A Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P1)

• ClinicalTrials.gov Identifier: NCT01695239
• Recruitment Status: Completed
• First Posted: September 27, 2012
• Results First Posted: October 27, 2016
• Last Update Posted: January 8, 2019
• 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: Psoriasis, Arthritic
• Interventions: Drug: Ixekizumab; Drug: Placebo; Drug: Adalimumab
• Enrollment: 417

Participant Flow

Recruitment Details
Pre-assignment Details	The Double-Blind Treatment Period was Week 0 up to Week 24 (Inadequate responders (IR) Week 16-24) followed by the combined extension period and long-term extension period from Week 24 to Week 156.

Arm/Group Title	Placebo (PBO)	Adalimumab (ADA) Q2W	Ixe Q4W	Ixe Q2W	Inadequate Responders (IR)/Ixe Q4W	IR/Ixe Q2W	IR PBO Washout	PBO Washout	Ixe Q4W/Ixe Q4W	Ixe Q2W/Ixe Q2W	Placebo Post-Treatment Follow-up Period	Adalimumab Post-Treatment Follow-up Period	Ixekizumab 80mg Q4W Post-Treatment Follow-up Period	Ixekizumab 80mg Q2W Post-Treatment Follow-up Period
Arm/Group Description	Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Placebo Week 16 inadequate responders (IRs) re-randomized to ixekizumab 80 mg every 4 weeks (Q4W) received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab Q4W IRs received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.	Placebo IRs re-randomized to ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab 80 mg Q2W IRs received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.	Adalimumab Q2W IRs re-randomized to ixekizumab 80 mg Q4W or ixekizumab 80 mg Q2W. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 16. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 18 to Week 22. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24.	Adalimumab Q2W participants re-randomized to ixekizumab 80 mg Q4W or ixekizumab Q2W Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 24. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 26 to Week 30. Participants received a dose of 80 mg of ixekizumab given as 1 SC injection at Week 32.	Participants continuing on 1 injection of ixekizumab 80 mg Q4W starting on Week 24 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 28 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 32 and ending on Week 156 alternating with placebo injections Q4W starting on Week 34 and ending on Week 154.	Participants continuing on 1 injection of ixekizumab 80 mg Q2W starting on Week 24 and ending on Week 156. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg Q2W at Week 16 and Week 24. Placebo washout participants who re-randomized at Week 16 receive a starting dose of 160 mg ixekizumab given as 2 SC injections of 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 28 and ending on Week 156. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 32 and ending on Week 156.	Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.	Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.	Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.	Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
Period Title: Double-Blind (DB) Treatment Period
Started	106	101	107	103	0	0	0	0	0	0	0	0	0	0
Received at Least 1 Dose of Study Drug	106	101	107	102	0	0	0	0	0	0	0	0	0	0
Classified as Inadequate Responder (IR)	27	9	11	10	0	0	0	0	0	0	0	0	0	0
Completed	91	97	97	96	0	0	0	0	0	0	0	0	0	0
Not Completed	15	4	10	7	0	0	0	0	0	0	0	0	0	0
Reason Not Completed
Entry Criteria Not Met	1	1	3	4	0	0	0	0	0	0	0	0	0	0
Adverse Event	2	2	2	3	0	0	0	0	0	0	0	0	0	0
Lack of Efficacy	4	0	2	0	0	0	0	0	0	0	0	0	0	0
Withdrawal by Subject	3	1	1	0	0	0	0	0	0	0	0	0	0	0
Sponsor Decision	3	0	1	0	0	0	0	0	0	0	0	0	0	0
Lost to Follow-up	1	0	1	0	0	0	0	0	0	0	0	0	0	0
Protocol Violation	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: IR Participants (Week 16 Up To Week 24)
Started	0 [1]	0 [1]	0 [1]	0 [1]	24 [2]	24 [3]	9 [4]	0	0	0	0	0	0	0
Completed	0	0	0	0	24	24	9	0	0	0	0	0	0	0
Not Completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0
[1] Only inadequate responders were included.; [2] IR from placebo who re-randomized to ixeQ4W and IR from ixeQ4W.; [3] IR from placebo who re-randomized to ixeQ2W and IR from ixeQ2W.; [4] Adalimumab Q2W (IR) who re-randomized to IxeQ2W or IxeQ4W and PBO for ixe and adalimumab.
Period Title: Placebo Washout (Week 24 Up To Week 32)
Started	0	0	0	0	0 [1]	0 [1]	0 [1]	88 [2]	0	0	0	0	0	0
Completed	0	0	0	0	0	0	0	77	0	0	0	0	0	0
Not Completed	0	0	0	0	0	0	0	11	0	0	0	0	0	0
Reason Not Completed
Lack of Efficacy	0	0	0	0	0	0	0	9	0	0	0	0	0	0
Adverse Event	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Entry Criteria Not Met	0	0	0	0	0	0	0	1	0	0	0	0	0	0
[1] Only included PBO washout participants.; [2] Adalimumab Q2W responders who re-randomized to IxeQ2W or IxeQ4W and PBO for ixe and adalimumab.
Period Title: Extension Long-Term Extension Periods
Started	0	0	0	0	0	0	0	0 [1]	187 [2]	183 [3]	0	0	0	0
Completed	0	0	0	0	0	0	0	0	121	122	0	0	0	0
Not Completed	0	0	0	0	0	0	0	0	66	61	0	0	0	0
Reason Not Completed
Lack of Efficacy	0	0	0	0	0	0	0	0	37	31	0	0	0	0
Adverse Event	0	0	0	0	0	0	0	0	15	21	0	0	0	0
Withdrawal by Subject	0	0	0	0	0	0	0	0	6	7	0	0	0	0
Physician Decision	0	0	0	0	0	0	0	0	3	0	0	0	0	0
Lost to Follow-up	0	0	0	0	0	0	0	0	2	1	0	0	0	0
Sponsor Decision	0	0	0	0	0	0	0	0	2	1	0	0	0	0
Death	0	0	0	0	0	0	0	0	1	0	0	0	0	0
[1] Only included combined extension participants.; [2] IxeQ4W who re-randomized to ixeQ4W.; [3] IxeQ2W who re-randomized to ixeQ2W.
Period Title: Post-Treatment Follow-Up Period
Started	0	0	0	0	0	0	0	0	0 [1]	0 [1]	20 [2]	1 [3]	165 [4]	171 [5]
Completed	0	0	0	0	0	0	0	0	0	0	20	0	156	166
Not Completed	0	0	0	0	0	0	0	0	0	0	0	1	9	5
Reason Not Completed
Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	1	6	3
Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	1	1
Physician Decision	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Protocol Violation	0	0	0	0	0	0	0	0	0	0	0	0	0	1
[1] Only included post-treatment follow-up participants.; [2] Participants who discontinued early and received PBO.; [3] Participants who discontinued early and received adalimumab.; [4] IxeQ4W participants who entered post-treatment follow-up.; [5] IxeQ2W participants who entered post-treatment follow-up.

Baseline Characteristics

Arm/Group Title		Placebo	ADA Q2W	Ixe Q4W	Ixe Q2W	Total
Arm/Group Description		Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Total of all reporting groups
Overall Number of Baseline Participants		106	101	107	103	417
Baseline Analysis Population Description		All randomized participants
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	106 participants	101 participants	107 participants	103 participants	417 participants
		50.60 (12.32)	48.58 (12.43)	49.07 (10.07)	49.79 (12.62)	49.52 (11.87)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	106 participants	101 participants	107 participants	103 participants	417 participants
	Female	58	50	62	55	225
	Male	48	51	45	48	192
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	106 participants	101 participants	107 participants	103 participants	417 participants
	American Indian or Alaska Native	2	3	2	2	9
	Asian	5	3	2	5	15
	Native Hawaiian or Other Pacific Islander	0	0	0	0	0
	Black or African American	0	0	0	0	0
	White	99	95	102	96	392
	More than one race	0	0	1	0	1
	Unknown or Not Reported	0	0	0	0	0
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	106 participants	101 participants	107 participants	103 participants	417 participants
Hispanic or Latino		6	5	5	4	20
Not Hispanic or Latino		92	83	94	87	356
Unknown or Not Reported		8	13	8	12	41
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	106 participants	101 participants	107 participants	103 participants	417 participants
Russia		9	7	10	8	34
United States		22	21	20	20	83
Japan		4	2	2	4	12
Ukraine		9	7	9	10	35
United Kingdom		3	5	5	4	17
Spain		4	2	3	4	13
Canada		1	1	2	0	4
Czechia		22	25	23	22	92
Netherlands		1	0	1	0	2
Belgium		2	2	0	1	5
Poland		16	14	15	15	60
Mexico		3	4	3	2	12
France		1	0	1	1	3
Bulgaria		3	4	5	4	16
Estonia		6	7	8	8	29

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])
Description	ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	101	107	103
Measure Type: Number; Unit of Measure: percentage of participants
	30.2	57.4	57.9	62.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab Q4W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ixekizumab Q2W
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Participants Achieving ACR20 Response
Description	ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	101	107	103
Measure Type: Number; Unit of Measure: percentage of participants
	31.1	51.5	57.0	60.2

3. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response
Description	ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	101	107	103
Measure Type: Number; Unit of Measure: percentage of participants
	15.1	38.6	40.2	46.6

4. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score
Description	ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	101	107	103
Measure Type: Number; Unit of Measure: percentage of participants
	5.7	25.7	23.4	34.0

5. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
Description	HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores 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), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post baseline HAQ-DI data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	105	97	103	98
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-0.1797 (0.0524)	-0.3712 (0.0510)	-0.4431 (0.0503)	-0.4963 (0.0507)

6. Secondary Outcome

Title	Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])
Description	The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post baseline mTSS data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	101	107	103
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.49 (0.086)	0.10 (0.085)	0.17 (0.082)	0.08 (0.083)

7. Secondary Outcome

Title	Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)
Description	The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	67	68	73	59
Measure Type: Number; Unit of Measure: percentage of participants
PASI 75	7.5	33.8	75.3	69.5
PASI 90	1.5	22.1	52.1	57.6
PASI 100	1.5	14.7	31.5	40.7

8. Secondary Outcome

Title	Change From Baseline in Leeds Enthesitis Index (LEI)
Description	The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	57	55	70	56
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-0.8 (0.24)	-0.8 (0.24)	-0.9 (0.21)	-1.5 (0.24)

9. Secondary Outcome

Title	Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
Description	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	67	68	73	59
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	0.2 (0.27)	-1.4 (0.28)	-2.6 (0.27)	-2.8 (0.30)

10. Secondary Outcome

Title	Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
Description	The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline and post baseline fatigue NRS data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	103	97	101	97
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-1.3 (0.25)	-1.5 (0.24)	-1.6 (0.24)	-1.9 (0.24)

11. Secondary Outcome

Title	Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)
Description	JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	91	95	97	96
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
Joint Space Narrowing Score	0.07 (0.031)	0.01 (0.031)	0.04 (0.030)	0.01 (0.030)
Bone Erosion Score	0.44 (0.077)	0.12 (0.077)	0.15 (0.075)	0.08 (0.075)

12. Secondary Outcome

Title	Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
Description	SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	99	95	98	95
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
PCS Score	2.94 (0.958)	6.78 (0.904)	7.45 (0.894)	8.24 (0.898)
MCS Score	2.67 (1.013)	4.22 (0.943)	4.86 (0.933)	3.39 (0.936)

13. Secondary Outcome

Title	Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])
Description	The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline and post baseline QIDS-SR16 data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	101	98	102	99
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-0.9 (0.36)	-1.6 (0.33)	-0.8 (0.32)	-0.7 (0.32)

14. Secondary Outcome

Title	Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease
Description	The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP measured in milligram/liter (mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline and post baseline DAS28-CRP data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	104	99	106	99
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-0.835 (0.1307)	-1.743 (0.1215)	-1.955 (0.1206)	-2.036 (0.1225)

15. Secondary Outcome

Title	Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)
Description	The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	101	107	103
Measure Type: Number; Unit of Measure: percentage of participants
	32.1	58.4	57.9	66.0

16. Secondary Outcome

Title	Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline
Description	The sPGA is the physician's determination of the severity of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	41	37	52	41
Measure Type: Number; Unit of Measure: percentage of participants
	17.1	62.2	65.4	73.2

17. Secondary Outcome

Title	Percent Change From Baseline in Body Surface Area (BSA)
Description	The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	99	94	100	91
Least Squares Mean (Standard Error); Unit of Measure: percent change in BSA
	-2.7 (1.36)	-9.5 (1.35)	-12.0 (1.32)	-10.6 (1.39)

18. Secondary Outcome

Title	Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline
Description	The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	69	68	66	69
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-2.4 (1.66)	-10.7 (1.49)	-14.0 (1.54)	-15.5 (1.49)

19. Secondary Outcome

Title	Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)
Description	The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	39	23	54	41
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-25.4 (6.53)	-57.1 (7.84)	-57.1 (5.67)	-48.3 (6.31)

20. Secondary Outcome

Title	Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description	The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	75	73	85	71
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-1.25 (0.268)	-2.42 (0.249)	-2.74 (0.234)	-2.91 (0.251)

21. Secondary Outcome

Title	Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)
Description	Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and post baseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.

Arm/Group Title	Placebo	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	103	107	100
Measure Type: Number; Unit of Measure: participants
Treatment Emergent (TE)	0	6	5
NAb	0	0	0

22. Secondary Outcome

Title	Percent Change in American College of Rheumatology-N (ACR-N) Score
Description	The ACR-N score is a continuous measure of clinical, laboratory, and functional outcomes that characterizes the percentage of improvement from baseline in disease activity and the lowest of either a) the percent change in tender joint count (TJC) b) the percent change in swollen joint count (SJC), or c) the median percent change of the remaining 5 ACR core criteria. An ACR-N score of X has improvement of at least X% in both TJC and SJC and a median improvement of at least X% in 5 criteria: patient's assessment of arthritis pain, PatGA, PGA, HAQ-DI and hs-CRP. ACR-N is calculated by allowing for negative results which indicate worsening. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment.
Time Frame	Baseline, 24 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants with post-baseline ACR data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	101	107	103
Least Squares Mean (Standard Error); Unit of Measure: percent change
	-4.182 (6.1417)	28.517 (5.9189)	33.509 (5.8905)	30.391 (5.9736)

23. Secondary Outcome

Title	Change From Baseline in Tender Joint Counts (TJC)
Description	TJC is calculated based on tenderness response of 68 joints. TJC possible values range from 0 to 68. A lower TJC indicated less joint tenderness. A higher TJC indicated more joint tenderness. TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post-baseline TJC data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	100	107	102
Least Squares Mean (Standard Error); Unit of Measure: joint counts
	-4.7 (1.14)	-10.1 (1.10)	-11.9 (1.08)	-13.6 (1.09)

24. Secondary Outcome

Title	Change From Baseline in Swollen Joint Counts (SJC)
Description	SJC is calculated based on swelling response of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joint swelling. A higher SJC indicated more joint swelling. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post-baseline SJC data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	100	107	102
Least Squares Mean (Standard Error); Unit of Measure: joint counts
	-3.5 (0.62)	-6.1 (0.59)	-7.0 (0.59)	-8.3 (0.59)

25. Secondary Outcome

Title	Change From Baseline in Patient's Assessment of Pain VAS
Description	The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post-baseline patient's assessment of pain data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	105	99	104	98
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-14.0 (2.68)	-30.0 (2.52)	-29.6 (2.51)	-31.6 (2.54)

26. Secondary Outcome

Title	Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS
Description	Participants scored their overall assessment of their PsA activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post-baseline patient's global assessment of disease activity data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	105	99	104	98
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-14.8 (2.65)	-31.6 (2.49)	-33.8 (2.48)	-35.6 (2.50)

27. Secondary Outcome

Title	Change From Baseline in Physician's Global Assessment of Disease Activity VAS
Description	The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 0 to 100 mm horizontal VAS. The scale ranged from 0 no disease activity to 100 extremely active disease activity. The scores were measured to the nearest millimeter from the left. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, 24 Weeks

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post-baseline physician's global assessment of disease activity data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	100	88	96	95
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-24.2 (2.14)	-34.7 (2.10)	-38.5 (2.06)	-42.0 (1.99)

28. Secondary Outcome

Title	Change From Baseline in C-Reactive Protein (CRP)
Description	CRP milligram/liter (mg/L) was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline and post-baseline CRP data.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	106	101	107	103
Least Squares Mean (Standard Error); Unit of Measure: milligram/liter (mg/L)
	-3.873 (1.4292)	-7.512 (1.2674)	-8.804 (1.2602)	-8.942 (1.2552)

29. Secondary Outcome

Title	Change From Baseline in Leeds Enthesitis Index (LEI)
Description	The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	57	56	70	59
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-0.8 (0.26)	-0.9 (0.23)	-1.3 (0.21)	-1.4 (0.24)

30. Secondary Outcome

Title	Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)
Description	The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Arm/Group Title		Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:		Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed		38	61	60	49
Measure Type: Number; Unit of Measure: percentage of participants
PASI 75	Number Analyzed	7 participants	37 participants	52 participants	45 participants
		10.9	55.2	71.2	80.4
PASI 90	Number Analyzed	4 participants	25 participants	41 participants	38 participants
		6.3	37.3	56.2	67.9
PASI 100	Number Analyzed	2 participants	16 participants	31 participants	30 participants
		3.1	23.9	42.5	53.6

31. Secondary Outcome

Title	Change From Baseline in Itching Severity Using the Itch NRS
Description	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.

Arm/Group Title	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
Arm/Group Description:	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed	67	68	73	59
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-0.3 (0.32)	-1.7 (0.29)	-2.9 (0.29)	-2.8 (0.31)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Arm/Group Title	Placebo (PBO) Double-Blind Period		Adalimumab (ADA) Double-Blind Period		Ixe Q2W Double-Blind Period		Ixe Q4W Double-Blind Period		IR IXE Q4W		IR IXE Q2W		IR PBO Washout		PBO Washout		IXE Q4W		IXE Q2W		PBO Post-Treatment Follow-Up Period		Adalimumab Post-Treatment Follow-up Period		IXE Q4W Post-Treatment Follow-up Period		IXE Q2W Post-Treatment Follow-up Period
Arm/Group Description	Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.		Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24		Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.		Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W or Placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.		Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.		Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.		Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.		Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.		Ixekizumab every 4 weeks (IxeQ4W) and IR IxeQ4W participants received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 24 to Week 156. Placebo and IR placebo (PBO) Washout participants re-randomized to Ixekizumab 80 mg Q4W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of alternating placebo for ixekizumab or ixekizumab Q2W from Week 26 to Week 156. PBO Washout participants re-randomized to ixekizumab 80 mg Q4W received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 32 to Week 156.		Ixekizumab Q2W (IxeQ2W) and IR IxeQ2W participants received one SC injection of 80 mg of ixekizumab Q2W from Week 24 to Week 156. Placebo and IR PBO Washout participants re-randomized to Ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 26 to Week 156. PBO Washout participants re-randomized to ixekizumab 80 mg Q2W received one SC injection of 80 mg of ixekizumab Q2W from Week 32 to Week 156.		Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.		Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.		Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.		Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
All-Cause Mortality
	Placebo (PBO) Double-Blind Period		Adalimumab (ADA) Double-Blind Period		Ixe Q2W Double-Blind Period		Ixe Q4W Double-Blind Period		IR IXE Q4W		IR IXE Q2W		IR PBO Washout		PBO Washout		IXE Q4W		IXE Q2W		PBO Post-Treatment Follow-Up Period		Adalimumab Post-Treatment Follow-up Period		IXE Q4W Post-Treatment Follow-up Period		IXE Q2W Post-Treatment Follow-up Period
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--		--/--		--/--		--/--		--/--		--/--		--/--		--/--		--/--		--/--		--/--
Serious Adverse Events
	Placebo (PBO) Double-Blind Period		Adalimumab (ADA) Double-Blind Period		Ixe Q2W Double-Blind Period		Ixe Q4W Double-Blind Period		IR IXE Q4W		IR IXE Q2W		IR PBO Washout		PBO Washout		IXE Q4W		IXE Q2W		PBO Post-Treatment Follow-Up Period		Adalimumab Post-Treatment Follow-up Period		IXE Q4W Post-Treatment Follow-up Period		IXE Q2W Post-Treatment Follow-up Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/106 (1.89%)		5/101 (4.95%)		6/107 (5.61%)		3/102 (2.94%)		0/24 (0.00%)		0/24 (0.00%)		0/9 (0.00%)		1/88 (1.14%)		28/187 (14.97%)		19/183 (10.38%)		0/20 (0.00%)		0/1 (0.00%)		2/165 (1.21%)		2/171 (1.17%)
Cardiac disorders
Acute myocardial infarction † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Atrial fibrillation † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	2	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Cardiac disorder † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	2	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Coronary artery disease † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	2/183 (1.09%)	2	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Coronary artery occlusion † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Myocardial ischaemia † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	2	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Eye disorders
Retinal detachment † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Gastrointestinal disorders
Abdominal pain † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Colitis ulcerative † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	5	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Duodenitis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Gastric ulcer † 1	0/106 (0.00%)	0	1/101 (0.99%)	2	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Gastrointestinal inflammation † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Impaired gastric emptying † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	1/102 (0.98%)	2	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Irritable bowel syndrome † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	1/171 (0.58%)	1
Oesophagitis † 1	0/106 (0.00%)	0	1/101 (0.99%)	2	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Pancreatitis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	1/107 (0.93%)	1	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Pancreatitis acute † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Hepatobiliary disorders
Cholecystitis acute † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	2/187 (1.07%)	2	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Cholelithiasis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	1/107 (0.93%)	1	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Immune system disorders
Anaphylactic reaction † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	1/165 (0.61%)	1	0/171 (0.00%)	0
Infections and infestations
Arthritis bacterial † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Cellulitis † 1	0/106 (0.00%)	0	1/101 (0.99%)	1	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Chronic tonsillitis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Gastroenteritis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	1/107 (0.93%)	1	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Gastroenteritis clostridial † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Gastroenteritis rotavirus † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Herpes zoster † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	1/102 (0.98%)	1	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Latent tuberculosis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Lower respiratory tract infection † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Oesophageal candidiasis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	1/102 (0.98%)	1	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Pneumonia † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	2/187 (1.07%)	2	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Pneumonia mycoplasmal † 1	0/106 (0.00%)	0	1/101 (0.99%)	1	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Upper respiratory tract infection † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Injury, poisoning and procedural complications
Anastomotic stenosis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Clavicle fracture † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Fall † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	2	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Fibula fracture † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	1/107 (0.93%)	1	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Humerus fracture † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Joint dislocation † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	3	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Ligament injury † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Limb injury † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Lumbar vertebral fracture † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Meniscus injury † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Perirenal haematoma † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Post procedural haematoma † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Tendon rupture † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Investigations
Hepatic enzyme increased † 1	1/106 (0.94%)	1	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Metabolism and nutrition disorders
Obesity † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	2	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Lumbar spinal stenosis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	1/107 (0.93%)	1	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Osteoarthritis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Psoriatic arthropathy † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	1/165 (0.61%)	1	0/171 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Breast cancer † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Invasive ductal breast carcinoma † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Large intestine benign neoplasm † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Melanocytic naevus † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Parathyroid tumour benign † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Prostate cancer † 1	0/48 (0.00%)	0	0/51 (0.00%)	0	0/45 (0.00%)	0	0/47 (0.00%)	0	0/8 (0.00%)	0	0/8 (0.00%)	0	0/1 (0.00%)	0	0/50 (0.00%)	0	0/78 (0.00%)	0	0/92 (0.00%)	0	0/10 (0.00%)	0	0/1 (0.00%)	0	0/71 (0.00%)	0	1/87 (1.15%)	1
Nervous system disorders
Carotid artery occlusion † 1	0/106 (0.00%)	0	1/101 (0.99%)	1	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Carotid artery stenosis † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	1/183 (0.55%)	2	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Cerebrovascular accident † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Cervical myelopathy † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	1/102 (0.98%)	1	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Depressed level of consciousness † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	1/187 (0.53%)	1	0/183 (0.00%)	0	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Guillain-barre syndrome † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Ischaemic stroke † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	0/107 (0.00%)	0	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0	0/88 (0.00%)	0	0/187 (0.00%)	0	1/183 (0.55%)	1	0/20 (0.00%)	0	0/1 (0.00%)	0	0/165 (0.00%)	0	0/171 (0.00%)	0
Post-traumatic headache † 1	0/106 (0.00%)	0	0/101 (0.00%)	0	1/107 (0.93%)	1	0/102 (0.00%)	0	0/24 (0.00%)	0	0/24 (0.00%)	0	0/9 (0.00%)	0