An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEYOND)

• ClinicalTrials.gov Identifier: NCT01885078
• Recruitment Status: Completed
• First Posted: June 24, 2013
• Results First Posted: February 1, 2022
• Last Update Posted: April 25, 2022
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Drug: Baricitinib; Drug: Placebo
• Enrollment: 2877

Participant Flow

Recruitment Details

Participants were eligible to participate in the Step-down period if they achieved a sustained (at least 3 months in JADY) low disease activity (CDAI score ≤10; for participants originating in Studies JADV, JADX, JADW, and JAGS) or sustained remission (CDAI score ≤2.8; for participants originating in Study JADZ). Eligible participants were randomized to 4 mg or 2 mg baricitinib once daily to evaluate if treatment with 2 mg maintains the low disease activity achieved with 4 mg baricitinib.

Pre-assignment Details

Participants who completed an originating study: I4V-MC-JADZ (NCT01711359), I4V-MC-JADV (NCT017103580, I4V-MC-JADX (NCT01721057), I4V-MC-JADW (NCT01721044), I4V-MC-JADA (NCT01185353), or I4V-MC-JAGS (NCT02265705) were eligible for enrollment into study JADY.

Arm/Group Title	JADZ 4 Milligram (mg) Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib	2 mg Baricitinib Step-down	4 mg Baricitinib Step-down
Arm/Group Description	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Period Title: Treatment Period
Started	451	1091	180	403	117	331	221	83	0	0
Received at Least Once Dose of Study Drug	451	1090	180	403	117	331	221	83	0	0
Completed	19	64	49	120	27	81	0	55	0	0
Not Completed	432	1027	131	283	90	250	221	28	0	0
Reason Not Completed
Adverse Event	52	136	30	73	17	72	24	5	0	0
Death	13	33	5	9	2	10	3	2	0	0
Lack of Efficacy	12	33	10	23	24	58	9	5	0	0
Lost to Follow-up	16	19	7	9	2	8	2	0	0	0
Physician Decision	19	21	5	12	9	24	4	3	0	0
Protocol Violation	3	5	0	3	1	6	0	0	0	0
Sponsor Decision	245	648	49	90	20	38	162	3	0	0
Withdrawal by Subject	72	132	25	63	15	34	17	10	0	0
Other	0	0	0	1	0	0	0	0	0	0
Period Title: Step-down Period
Started	0 [1]	0 [1]	0 [1]	0 [1]	0 [1]	0 [1]	0	0 [1]	592 [2]	594 [2]
Complete Through Week 96	0	0	0	0	0	0	0	0	407	455
Completed	0	0	0	0	0	0	0	0	523	533
Not Completed	0	0	0	0	0	0	0	0	69	61
Reason Not Completed
Sponsor Decision	0	0	0	0	0	0	0	0	1	1
Adverse Event	0	0	0	0	0	0	0	0	29	38
Withdrawal by Subject	0	0	0	0	0	0	0	0	25	15
Physician Decision	0	0	0	0	0	0	0	0	7	2
Death	0	0	0	0	0	0	0	0	4	3
Lost to Follow-up	0	0	0	0	0	0	0	0	1	1
Lack of Efficacy	0	0	0	0	0	0	0	0	1	0
Protocol Violation	0	0	0	0	0	0	0	0	1	1
[1] Not all participants were eligible to enter the Step-Down Period.; [2] Eligible participants were offered the option of participating in the Step-Down Period.

Baseline Characteristics

Arm/Group Title		JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib	Total
Arm/Group Description		4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	Total of all reporting groups
Overall Number of Baseline Participants		451	1090	180	403	117	331	221	83	2876
Baseline Analysis Population Description		All participants who received at least one dose of study drug.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	451 participants	1090 participants	180 participants	403 participants	117 participants	331 participants	221 participants	83 participants	2876 participants
	<=18 years	0	0	0	0	0	0	0	0	0
	Between 18 and 65 years	386	881	150	335	86	253	199	68	2358
	>=65 years	65	209	30	68	31	78	22	15	518
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	451 participants	1090 participants	180 participants	403 participants	117 participants	331 participants	221 participants	83 participants	2876 participants
	Female	326	847	144	335	87	275	177	71	2262
	Male	125	243	36	68	30	56	44	12	614
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	451 participants	1090 participants	180 participants	403 participants	117 participants	331 participants	221 participants	83 participants	2876 participants
	American Indian or Alaska Native	35	56	1	12	6	21	6	6	143
	Asian	122	321	50	94	6	19	167	2	781
	Native Hawaiian or Other Pacific Islander	0	0	0	1	0	0	0	0	1
	Black or African American	17	4	9	10	7	12	3	2	64
	White	275	691	119	283	98	275	45	73	1859
	More than one race	2	17	1	2	0	1	0	0	23
	Unknown or Not Reported	0	1	0	1	0	3	0	0	5
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	451 participants	1090 participants	180 participants	403 participants	117 participants	331 participants	221 participants	83 participants	2876 participants
United States		68	64	39	103	52	136	0	26	488
Czechia		0	29	3	10	0	0	0	14	56
Portugal		3	3	2	3	0	0	0	0	11
Russia		35	70	10	7	0	0	0	0	122
Greece		0	2	0	0	2	4	0	0	8
South Korea		6	43	6	8	3	6	0	0	72
Latvia		0	8	0	0	0	0	0	0	8
Sweden		3	0	0	0	0	0	0	0	3
Austria		2	0	0	0	3	12	0	0	17
Netherlands		0	0	0	0	1	0	0	0	1
China		0	41	0	0	0	0	167	0	208
Poland		0	66	11	37	9	22	0	11	156
Brazil		16	0	0	0	0	0	14	0	30
Slovenia		0	5	0	0	0	0	0	0	5
Slovakia		0	17	3	7	0	0	0	0	27
France		0	16	0	0	6	14	0	0	36
Lithuania		0	21	0	0	0	0	0	0	21
Croatia		0	0	2	1	0	0	0	6	9
Argentina		87	226	15	44	3	15	40	0	430
Romania		0	14	2	2	0	0	0	3	21
Hungary		0	30	8	11	0	0	0	11	60
Japan		82	215	4	13	3	11	0	0	328
United Kingdom		10	8	3	1	1	3	0	0	26
Switzerland		0	0	0	0	0	7	0	0	7
India		28	0	16	27	0	0	0	0	71
Spain		0	28	9	24	6	19	0	0	86
Canada		13	8	8	13	3	2	0	0	47
Turkey		0	0	0	0	1	2	0	0	3
Belgium		20	7	3	8	0	3	0	0	41
Taiwan		0	12	23	46	0	0	0	0	81
Denmark		0	0	0	0	2	3	0	0	5
South Africa		16	40	0	0	0	0	0	0	56
Italy		12	0	3	6	3	3	0	0	27
Mexico		39	115	8	14	5	21	0	12	214
Israel		0	0	0	0	6	21	0	0	27
Australia		0	0	1	12	5	14	0	0	32
Germany		11	2	1	6	3	13	0	0	36

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
Description	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%. An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Time Frame	Baseline through 84 Months

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and did not discontinue the study for the reason 'Lost to Follow-up' at the first postbaseline visit in study JADY.

Arm/Group Title	2 mg Baricitinib	4 mg Baricitinib	2 mg Baricitinib Step-down	4 mg Baricitinib Step-down
Arm/Group Description:	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Overall Number of Participants Analyzed	297	2579	592	594
Measure Type: Number; Unit of Measure: participants
Adverse Events	234	1532	270	315
Serious Adverse Events	112	517	164	178

2. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Description	ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	92.6; (89.7 to 94.7)	88.4; (86.3 to 90.2)	79.3; (72.6 to 84.7)	79.5; (75.1 to 83.3)	72.3; (62.9 to 80.1)	70.8; (65.2 to 75.9)	86.7; (81.4 to 90.6)	75.6; (65.1 to 83.8)

3. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Description	ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	78.3; (74.1 to 82.0)	76.6; (73.9 to 79.1)	71.6; (64.4 to 77.9)	70.5; (65.6 to 74.9)	57.4; (47.7 to 66.6)	55.8; (49.9 to 61.6)	73.8; (67.5 to 79.3)	71.8; (61.0 to 80.6)

4. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20
Description	ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	67.3; (62.7 to 71.6)	65.6; (62.6 to 68.4)	60.4; (52.8 to 67.4)	56.0; (50.9 to 61.0)	50.5; (40.9 to 60.0)	43.1; (37.3 to 49.0)	24.8; (19.4 to 31.0)	60.3; (49.2 to 70.4)

5. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Description	ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	80.0; (75.9 to 83.5)	67.7; (64.8 to 70.5)	58.0; (50.5 to 65.2)	58.2; (53.1 to 63.1)	45.5; (36.2 to 55.2)	43.8; (38.0 to 49.7)	69.0; (62.5 to 74.9)	43.6; (33.1 to 54.6)

6. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Description	ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	67.8; (63.2 to 72.1)	61.6; (58.6 to 64.5)	49.7; (42.3 to 57.2)	53.3; (48.2 to 58.3)	43.6; (34.3 to 53.3)	36.5; (31.0 to 42.3)	59.0; (52.3 to 65.5)	43.6; (33.1 to 54.6)

7. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50
Description	ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	59.9; (55.1 to 64.5)	52.7; (49.7 to 55.7)	44.4; (37.1 to 51.9)	43.2; (38.2 to 48.3)	37.6; (28.8 to 47.4)	32.1; (26.9 to 37.9)	18.6; (13.9 to 24.4)	37.2; (27.3 to 48.3)

8. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Description	ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	61.3; (56.6 to 65.9)	45.7; (42.7 to 48.8)	34.9; (28.1 to 42.4)	35.8; (31.1 to 40.8)	28.7; (20.8 to 38.2)	25.9; (21.1 to 31.4)	42.9; (36.4 to 49.6)	26.9; (18.3 to 37.7)

9. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Description	ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	54.4; (49.6 to 59.1)	44.1; (41.1 to 47.1)	35.5; (28.7 to 43.0)	32.5; (27.9 to 37.5)	24.8; (17.4 to 34.0)	21.5; (17.1 to 26.8)	35.2; (29.1 to 41.9)	21.8; (14.1 to 32.2)

10. Secondary Outcome

Title	Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70
Description	ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 Milligram (mg) Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	48.2; (43.5 to 53.0)	39.1; (36.1 to 42.1)	28.4; (22.1 to 35.6)	28.4; (24.0 to 33.2)	23.8; (16.5 to 32.9)	18.2; (14.1 to 23.2)	12.9; (9.0 to 18.1)	19.2; (12.0 to 29.3)

11. Secondary Outcome

Title	Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Description	Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	81.9; (77.9 to 85.3)	71.9; (69.0 to 74.5)	66.3; (58.9 to 73.0)	68.6; (63.7 to 73.1)	50.5; (40.9 to 60.0)	51.1; (45.2 to 57.0)	72.4; (66.0 to 78.0)	59.0; (47.9 to 69.2)

12. Secondary Outcome

Title	Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Description	Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	71.8; (67.3 to 75.9)	65.5; (62.5 to 68.3)	59.2; (51.6 to 66.3)	59.3; (54.2 to 64.2)	47.5; (38.1 to 57.2)	41.6; (35.9 to 47.5)	61.0; (54.2 to 67.3)	60.3; (49.2 to 70.4)

13. Secondary Outcome

Title	Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2
Description	Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	61.1; (56.3 to 65.6)	58.9; (55.9 to 61.9)	46.7; (39.4 to 54.3)	50.0; (44.9 to 55.1)	44.6; (35.2 to 54.3)	34.3; (28.9 to 40.1)	21.0; (16.0 to 27.0)	53.8; (42.9 to 64.5)

14. Secondary Outcome

Title	Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Description	Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 Milligram (mg) Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	65.6; (61.0 to 70.0)	52.3; (49.3 to 55.4)	50.9; (43.4 to 58.3)	46.2; (41.1 to 51.3)	34.7; (26.1 to 44.3)	32.8; (27.6 to 38.6)	52.4; (45.6 to 59.0)	44.9; (34.3 to 55.9)

15. Secondary Outcome

Title	Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Description	Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	59.9; (55.1 to 64.5)	51.0; (47.9 to 54.0)	43.8; (36.5 to 51.3)	43.2; (38.2 to 48.3)	31.7; (23.4 to 41.3)	26.3; (21.4 to 31.8)	38.6; (32.2 to 45.3)	35.9; (26.1 to 47.0)

16. Secondary Outcome

Title	Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6
Description	Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	51.1; (46.3 to 55.8)	44.0; (41.0 to 47.0)	36.1; (29.2 to 43.6)	37.7; (32.9 to 42.8)	29.7; (21.7 to 39.2)	26.6; (21.8 to 32.2)	13.3; (9.4 to 18.6)	43.6; (33.1 to 54.6)

17. Secondary Outcome

Title	Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Description	DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	61.8; (57.1 to 66.3)	48.4; (45.3 to 51.4)	46.2; (38.8 to 53.7)	48.4; (43.3 to 53.5)	31.7; (23.4 to 41.3)	31.8; (26.5 to 37.5)	41.0; (34.5 to 47.7)	35.9; (26.1 to 47.0)

18. Secondary Outcome

Title	Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Description	DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	54.4; (49.6 to 59.1)	46.1; (43.1 to 49.2)	40.2; (33.1 to 47.8)	41.0; (36.1 to 46.1)	22.8; (15.7 to 31.9)	23.7; (19.1 to 29.1)	33.8; (27.8 to 40.4)	37.2; (27.3 to 48.3)

19. Secondary Outcome

Title	Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2
Description	DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	48.7; (43.9 to 53.5)	41.3; (38.3 to 44.3)	36.1; (29.2 to 43.6)	32.5; (27.9 to 37.5)	23.8; (16.5 to 32.9)	21.9; (17.4 to 27.2)	11.4; (7.8 to 16.4)	37.2; (27.3 to 48.3)

20. Secondary Outcome

Title	Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Description	DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	36.8; (32.3 to 41.5)	29.3; (26.6 to 32.2)	24.3; (18.4 to 31.2)	26.8; (22.5 to 31.5)	20.8; (14.0 to 29.7)	13.1; (9.6 to 17.7)	25.2; (19.8 to 31.5)	15.4; (9.0 to 25.0)

21. Secondary Outcome

Title	Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Description	DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	38.9; (34.4 to 43.7)	24.7; (22.1 to 27.4)	24.3; (18.4 to 31.2)	23.2; (19.2 to 27.8)	15.8; (10.0 to 24.2)	10.2; (7.2 to 14.4)	19.5; (14.7 to 25.4)	23.1; (15.1 to 33.6)

22. Secondary Outcome

Title	Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6
Description	DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	31.3; (27.0 to 35.9)	23.9; (21.4 to 26.6)	22.5; (16.8 to 29.4)	19.4; (15.7 to 23.8)	11.9; (6.9 to 19.6)	8.8; (6.0 to 12.7)	7.1; (4.4 to 11.4)	19.2; (12.0 to 29.3)

23. Secondary Outcome

Title	Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Description	Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	30.5; (26.3 to 35.1)	20.8; (18.4 to 23.4)	17.8; (12.7 to 24.2)	17.8; (14.2 to 22.0)	8.9; (4.8 to 16.1)	9.5; (6.6 to 13.5)	17.1; (12.6 to 22.8)	12.8; (7.1 to 22.0)

24. Secondary Outcome

Title	Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Description	Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	30.8; (26.6 to 35.4)	20.3; (18.0 to 22.9)	16.6; (11.7 to 22.9)	15.0; (11.7 to 19.1)	9.9; (5.5 to 17.3)	8.0; (5.4 to 11.9)	11.9; (8.2 to 17.0)	15.4; (9.0 to 25.0)

25. Secondary Outcome

Title	Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response
Description	Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) <=1, swollen joint count (SJC28) <=1, hsCRP <=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) <=1 cm.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	26.5; (22.5 to 30.9)	17.7; (15.5 to 20.1)	13.6; (9.2 to 19.6)	14.2; (11.0 to 18.2)	6.9; (3.4 to 13.6)	7.3; (4.8 to 11.0)	5.2; (2.9 to 9.1)	15.4; (9.0 to 25.0)

26. Secondary Outcome

Title	Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Description	X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame	Baseline, Year 1

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 1 data. Zero participants analyzed, no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	0	0	0	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

27. Secondary Outcome

Title	Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Description	X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame	Baseline, Year 3

Outcome Measure Data

Analysis Population Description

All enrolled participants treated with at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 3 data. JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	387	343	137	301	0	0	203	0
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	1.30; (0.94 to 1.67)	1.64; (1.38 to 1.90)	1.13; (0.61 to 1.66)	1.13; (0.78 to 1.48)			1.20; (0.61 to 1.80)

28. Secondary Outcome

Title	Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)
Description	X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.
Time Frame	Baseline, Year 5

Outcome Measure Data

Analysis Population Description

All enrolled participants treated with at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 5 data. JAGS, JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	349	870	127	276	0	0	0	0
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	1.64; (1.18 to 2.09)	2.18; (1.85 to 2.51)	1.32; (0.69 to 1.96)	1.58; (1.15 to 2.02)

29. Secondary Outcome

Title	Percentage of Participants With mTSS Change ≤0
Description	X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY. Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	0	0	0	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

30. Secondary Outcome

Title	Percentage of Participants With mTSS Change ≤0
Description	X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY. JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	0	0	210	0
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	53.5; (48.7 to 58.2)	53.0; (50.0 to 56.0)	0.6; (0.1 to 3.3)	0.8; (0.3 to 2.4)			0; (0.0 to 1.8)

31. Secondary Outcome

Title	Percentage of Participants With mTSS Change ≤0
Description	X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448, with higher scores representing greater damage.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY. JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	0	0	210	0
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	1.7; (0.8 to 3.4)	0.6; (0.3 to 1.3)	0; (0.0 to 2.2)	0.5; (0.1 to 2.0)			0; (0.0 to 1.8)

32. Secondary Outcome

Title	Change From Baseline of Originating Study in Joint Space Narrowing at Year 1
Description	X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Time Frame	Baseline, Year 1

Outcome Measure Data

Analysis Population Description

All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	0	0	0	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

33. Secondary Outcome

Title	Change From Baseline of Originating Study in Joint Space Narrowing at Year 3
Description	X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
Time Frame	Baseline, Year 3

Outcome Measure Data

Analysis Population Description

All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	387	943	137	301	0	0	203	0
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	0.45; (0.26 to 0.63)	0.72; (0.59 to 0.86)	0.54; (0.25 to 0.83)	0.44; (0.24 to 0.63)			0.52; (0.23 to 0.82)

34. Secondary Outcome

Title	Change From Baseline of Originating Study in Joint Space Narrowing at Year 5
Description	X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing
Time Frame	Baseline, Year 5

Outcome Measure Data

Analysis Population Description

All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JAGS, JADW, and JADA, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	349	870	127	276	0	0	0	0
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	0.59; (0.36 to 0.83)	1.00; (0.84 to 1.17)	0.68; (0.34 to 1.02)	0.60; (0.37 to 0.83)

35. Secondary Outcome

Title	Change From Baseline of Originating Study in Duration of Morning Stiffness
Description	Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame	Baseline, Year 1

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	450	633	0	0	110	308	221	78
Mean (Standard Deviation); Unit of Measure: minutes
	-102.72 (155.27)	-73.53 (144.22)			-75.07 (139.00)	-73.88 (149.55)	-68.74 (148.34)	-37.12 (61.34)

36. Secondary Outcome

Title	Change From Baseline of Originating Study in Duration of Morning Stiffness
Description	Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame	Baseline, Year 3

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	387	556	0	0	81	222	192	69
Mean (Standard Deviation); Unit of Measure: minutes
	-112.41 (159.78)	-77.78 (141.01)			-84.60 (127.85)	-67.79 (154.05)	-90.61 (147.70)	-47.13 (52.97)

37. Secondary Outcome

Title	Change From Baseline of Originating Study in Duration of Morning Stiffness
Description	Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Time Frame	Baseline, Year 5

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.

Arm/Group Title	JADZ 4 Milligram (mg) Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	330	470	0	0	70	169	128	57
Mean (Standard Deviation); Unit of Measure: minutes
	-111.45 (164.74)	-82.48 (137.23)			-88.37 (146.73)	-91.57 (163.88)	-92.75 (125.39)	-45.89 (60.43)

38. Secondary Outcome

Title	Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Description	The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame	Baseline, Year 1

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.

Arm/Group Title	JADZ 4 Milligram (mg) Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	450	1088	171	383	108	305	221	0
Mean (Standard Deviation); Unit of Measure: score on a scale
UK	0.28 (0.26)	0.23 (0.24)	0.19 (0.26)	0.20 (0.23)	0.21 (0.22)	0.19 (0.24)	0.20 (0.26)
US	0.19 (0.18)	0.16 (0.17)	0.13 (0.18)	0.14 (0.16)	0.14 (0.15)	0.13 (0.16)	0.14 (0.18)

39. Secondary Outcome

Title	Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Description	The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame	Baseline, Year 3

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	386	952	146	309	80	219	190	0
Mean (Standard Deviation); Unit of Measure: score on a scale
UK	0.33 (0.24)	0.24 (0.25)	0.20 (0.26)	0.21 (0.26)	0.21 (0.22)	0.22 (0.25)	0.24 (0.24)
US	0.23 (0.17)	0.17 (0.17)	0.15 (0.18)	0.15 (0.18)	0.14 (0.15)	0.15 (0.17)	0.17 (0.17)

40. Secondary Outcome

Title	Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores
Description	The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Time Frame	Baseline, Year 5

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	330	820	122	264	70	169	127	0
Mean (Standard Deviation); Unit of Measure: score on a scale
UK	0.35 (0.24)	0.26 (0.26)	0.19 (0.25)	0.20 (0.26)	0.21 (0.22)	0.22 (0.30)	0.25 (0.26)
US	0.24 (0.16)	0.18 (0.18)	0.13 (0.17)	0.14 (0.18)	0.15 (0.15)	0.15 (0.20)	0.18 (0.18)

41. Secondary Outcome

Title	Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Description	The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame	Baseline, Year 1

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	450	1088	171	383	108	305	221	0
Mean (Standard Deviation); Unit of Measure: millimeter (mm)
	24.69 (28.50)	19.72 (28.17)	15.13 (26.78)	18.32 (26.35)	20.96 (24.53)	14.98 (30.21)	18.47 (27.31)

42. Secondary Outcome

Title	Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Description	The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame	Baseline, Year 3

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	386	952	146	309	80	219	190	0
Mean (Standard Deviation); Unit of Measure: mm
	28.48 (29.88)	22.10 (28.02)	16.29 (25.37)	16.48 (30.24)	23.53 (24.70)	18.79 (30.03)	21.45 (29.64)

43. Secondary Outcome

Title	Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Description	The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Time Frame	Baseline, Year 5

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	330	820	122	264	70	169	127	0
Mean (Standard Deviation); Unit of Measure: mm
	31.13 (28.15)	23.93 (28.45)	13.82 (29.59)	19.34 (27.48)	26.19 (27.09)	23.57 (31.67)	27.31 (27.19)

44. Secondary Outcome

Title	Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Description	The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	81.6; (77.6 to 85.0)	75.3; (72.6 to 77.9)	68.6; (61.3 to 75.2)	69.9; (65.1 to 74.4)	52.5; (42.8 to 61.9)	50.7; (44.8 to 56.6)	73.3; (67.0 to 78.9)	60.3; (49.2 to 70.4)

45. Secondary Outcome

Title	Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Description	The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	73.3; (68.8 to 77.3)	67.7; (64.8 to 70.5)	60.4; (52.8 to 67.4)	60.4; (55.3 to 65.3)	49.5; (40.0 to 59.1)	44.5; (38.8 to 50.4)	61.4; (54.7 to 67.8)	56.4; (45.4 to 66.9)

46. Secondary Outcome

Title	Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10
Description	The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame	Years 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	61.6; (56.8 to 66.1)	61.1; (58.1 to 64.0)	51.5; (44.0 to 58.9)	54.6; (49.5 to 59.7)	44.6; (35.2 to 54.3)	35.4; (30.0 to 41.2)	21.9; (16.8 to 28.0)	56.4; (45.4 to 66.9)

47. Secondary Outcome

Title	Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤ 2.8
Description	The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	44.9; (40.2 to 49.7)	28.3; (25.7 to 31.2)	21.9; (16.3 to 28.7)	25.1; (21.0 to 29.8)	16.8; (10.8 to 25.3)	13.5; (10.0 to 18.1)	22.9; (17.7 to 29.0)	14.1; (8.1 to 23.5)

48. Secondary Outcome

Title	Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
Description	The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	40.1; (35.5 to 44.9)	30.0; (27.3 to 32.8)	21.9; (16.3 to 28.7)	23.5; (19.4 to 28.1)	22.8; (15.7 to 31.9)	15.0; (11.2 to 19.7)	18.6; (13.9 to 24.4)	20.5; (13.0 to 30.8)

49. Secondary Outcome

Title	Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8
Description	The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	33.9; (29.5 to 38.6)	25.0; (22.5 to 27.8)	19.5; (14.3 to 26.2)	22.4; (18.4 to 27.0)	15.8; (10.0 to 24.2)	12.8; (9.3 to 17.2)	8.1; (5.1 to 12.6)	19.2; (12.0 to 29.3)

50. Secondary Outcome

Title	Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Description	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	89.7; (86.5 to 92.3)	81.4; (78.9 to 83.7)	78.7; (71.9 to 84.2)	75.4; (70.7 to 79.5)	74.3; (65.0 to 81.8)	69.3; (63.6 to 74.5)	80.0; (74.1 to 84.8)	48.7; (37.9 to 59.6)

51. Secondary Outcome

Title	Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Description	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	75.4; (71.1 to 79.3)	70.4; (67.6 to 73.1)	64.5; (57.0 to 71.3)	63.4; (58.3 to 68.2)	56.4; (46.7 to 65.7)	54.4; (48.5 to 60.2)	68.1; (61.5 to 74.0)	47.4; (36.7 to 58.4)

52. Secondary Outcome

Title	Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22
Description	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	65.2; (60.5 to 69.6)	58.5; (55.5 to 61.5)	51.5; (44.0 to 58.9)	51.4; (46.3 to 56.4)	50.5; (40.9 to 60.0)	39.4; (33.8 to 45.3)	20.0; (15.2 to 25.9)	39.7; (29.6 to 50.8)

53. Secondary Outcome

Title	Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Description	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	85.4; (81.7 to 88.5)	75.6; (72.9 to 78.1)	72.8; (65.6 to 78.9)	69.4; (64.5 to 73.9)	65.3; (55.7 to 73.9)	61.7; (55.8 to 67.2)	75.2; (69.0 to 80.6)	43.6; (33.1 to 54.6)

54. Secondary Outcome

Title	Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Description	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	72.6; (68.1 to 76.6)	64.8; (61.8 to 67.6)	61.5; (54.0 to 68.5)	58.5; (53.4 to 63.4)	50.5; (40.9 to 60.0)	47.8; (42.0 to 53.7)	63.8; (57.1 to 70.0)	38.5; (28.4 to 49.6)

55. Secondary Outcome

Title	Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3
Description	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: percentage of participants
	62.8; (58.0 to 67.3)	53.4; (50.3 to 56.4)	46.7; (39.4 to 54.3)	46.2; (41.1 to 51.3)	46.5; (37.1 to 56.2)	35.0; (29.6 to 40.9)	19.5; (14.7 to 25.4)	34.6; (25.0 to 45.7)

56. Secondary Outcome

Title	Change From Baseline of Originating Study in Bone Erosion Score
Description	The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion. LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Time Frame	Baseline, Year 1

Outcome Measure Data

Analysis Population Description

All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	0	0	0	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

57. Secondary Outcome

Title	Change From Baseline of Originating Study in Bone Erosion Score
Description	The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion. LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Time Frame	Baseline, Year 3

Outcome Measure Data

Analysis Population Description

All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	387	943	137	301	0	0	203	0
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	0.85; (0.63 to 1.08)	0.92; (0.76 to 1.07)	0.59; (0.30 to 0.89)	0.69; (0.49 to 0.89)			0.68; (0.32 to 1.03)

58. Secondary Outcome

Title	Change From Baseline of Originating Study in Bone Erosion Score
Description	The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion. LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.
Time Frame	Baseline, Year 5

Outcome Measure Data

Analysis Population Description

All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JAGS, JADW, and JADA, zero participants analyzed due to no data collected in this study or originating study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	349	870	127	276	0	0	0	0
Least Squares Mean (95% Confidence Interval); Unit of Measure: score on a scale
	1.04; (0.77 to 1.32)	1.18; (0.98 to 1.38)	0.65; (0.28 to 1.01)	0.98; (0.74 to 1.23)

59. Secondary Outcome

Title	Healthcare Resource Utilization
Description	Number of visits to medical care providers related to treatment of Rheumatoid Arthritis (RA) outside of the clinical study. Reported here are healthcare consultations and emergency room consultations from end of originating study to end of participation in study JADY.
Time Frame	Baseline up to 84 Months

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and had access to and utilized healthcare services outside of the clinical study.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	451	1090	180	403	117	331	221	83
Measure Type: Number; Unit of Measure: consultations
Healthcare Consultations	3134	11108	2160	4573	2380	5410	717	749
Emergency Room Consultations	95	244	52	131	73	154	40	16

60. Secondary Outcome

Title	Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Description	SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	81.6; (77.6 to 85.0)	75.2; (72.5 to 77.8)	70.4; (63.1 to 76.8)	69.1; (64.2 to 73.6)	53.5; (43.8 to 62.9)	53.6; (47.7 to 59.5)	72.4; (66.0 to 78.0)	59.0; (47.9 to 69.2)

61. Secondary Outcome

Title	Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Description	SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Time Frame	Year 3 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	73.3; (68.8 to 77.3)	67.8; (64.9 to 70.6)	60.9; (53.4 to 68.0)	62.3; (57.2 to 67.1)	48.5; (39.0 to 58.1)	44.5; (38.8 to 50.4)	60.0; (53.3 to 66.4)	57.7; (46.6 to 68.0)

62. Secondary Outcome

Title	Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11
Description	SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.
Time Frame	Year 5 after entry into JADY

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Arm/Group Title	JADZ 4 mg Baricitinib	JADV 4 mg Baricitinib	JADX 2 mg Baricitinib	JADX 4 mg Baricitinib	JADW 2 mg Baricitinib	JADW 4 mg Baricitinib	JAGS 4 mg Baricitinib	JADA 4 mg Baricitinib
Arm/Group Description:	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	2 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.	4 mg Baricitinib administered orally once daily.
Overall Number of Participants Analyzed	419	1034	169	366	101	274	210	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	61.3; (56.6 to 65.9)	61.2; (58.2 to 64.1)	51.5; (44.0 to 58.9)	53.3; (48.2 to 58.3)	46.5; (37.1 to 56.2)	35.4; (30.0 to 41.2)	23.3; (18.1 to 29.5)	57.7; (46.6 to 68.0)

63. Secondary Outcome

Title	Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3
Description	SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.
Time Frame	Year 1 after entry into JADY

Outcome Measure Data

Analysis