Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT01970488
• Recruitment Status: Completed
• First Posted: October 28, 2013
• Results First Posted: December 13, 2016
• Last Update Posted: April 3, 2019
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Psoriasis
• Interventions: Biological: Adalimumab; Biological: ABP 501
• Enrollment: 350

Participant Flow

Recruitment Details	This study was conducted at 49 centers in 6 countries (Australia, Canada, France, Germany, Hungary, and Poland). Participants were randomized in a 1:1 ratio to receive ABP 501 or adalimumab.
Pre-assignment Details	Randomization was stratified based on prior biologic use for psoriasis and geographic region. At week 16 participants with a PASI 50 response (≥ 50% improvement in Psoriasis Area and Severity Index score) continued on study; those initially randomized to adalimumab were re-randomized to receive either ABP 501 or adalimumab.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Period Title: Part 1: Through Week 16
Started	175	175	0	0	0
Received Treatment	174	173	0	0	0
Completed	164	162	0	0	0
Not Completed	11	13	0	0	0
Reason Not Completed
Protocol-specified Criteria	1	2	0	0	0
Protocol Violation	1	2	0	0	0
Adverse Event	6	5	0	0	0
Withdrawal by Subject	3	2	0	0	0
Lost to Follow-up	0	2	0	0	0
Period Title: Part 2: Post Week 16
Started	0	0	152 [1]	79 [1]	77 [1]
Completed	0	0	135	71	69
Not Completed	0	0	17	8	8
Reason Not Completed
Physician Decision	0	0	0	0	1
Non-compliance	0	0	1	0	0
Lack of Efficacy	0	0	2	3	1
Adverse Event	0	0	5	1	1
Withdrawal by Subject	0	0	8	3	3
Lost to Follow-up	0	0	1	1	2
[1] Only participants who completed week 16 and with a PASI 50 response continued in Part 2

Baseline Characteristics

Arm/Group Title		Part 1: ABP 501	Part 1: Adalimumab	Total
Arm/Group Description		Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		175	175	350
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	175 participants	175 participants	350 participants
		45.1 (12.95)	44.0 (13.68)	44.6 (13.31)
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	175 participants	175 participants	350 participants
< 65 years		164	163	327
≥ 65 years		11	12	23
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	175 participants	175 participants	350 participants
	Female	63 36.0%	59 33.7%	122 34.9%
	Male	112 64.0%	116 66.3%	228 65.1%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	175 participants	175 participants	350 participants
White		167	157	324
Black or African American		0	2	2
Asian		5	8	13
Native Hawaiian or Other Pacific Islander		0	1	1
Mixed Race		0	1	1
Other		1	3	4
Unknown		2	3	5
Prior Biological Use for Psoriasis; Measure Type: Number; Unit of measure: Participants	Number Analyzed	175 participants	175 participants	350 participants
Yes		33	30	63
No		142	145	287
Geographic Region; Measure Type: Number; Unit of measure: Participants	Number Analyzed	175 participants	175 participants	350 participants
Eastern Europe		71	70	141
Western Europe		43	43	86
Other		61	62	123
Static Physician's Global Assessment (sPGA) [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	175 participants	175 participants	350 participants
Clear		0	0	0
Almost Clear		0	0	0
Mild		0	0	0
Moderate		106	102	208
Severe		61	61	122
Very Severe		7	10	17
Missing		1	2	3
		[1] Measure Description: The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).
Psoriasis Area and Severity Index (PASI) Score [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	175 participants	175 participants	350 participants
		19.68 (8.100)	20.48 (7.880)	20.08 (7.990)
		[1] Measure Description: The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Data are reported for 174 and 173 participants in each reporting group respectively.
Body Surface Area (BSA) Affected by Psoriasis [1]; Mean (Standard Deviation); Unit of measure: Percentage of BSA
	Number Analyzed	175 participants	175 participants	350 participants
		25.3 (15.02)	28.5 (16.82)	26.9 (16.00)
		[1] Measure Description: Data are reported for 174 and 173 participants in each reporting group respectively.

Outcome Measures

1. Primary Outcome

Title	Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
Description	The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

This analysis was performed using the full analysis set which includes all participants initially randomized in the study. Last observation carried forward (LOCF) imputation was used for participants with at least one post-baseline value.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab
Arm/Group Description:	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
Overall Number of Participants Analyzed	172	173
Mean (Standard Deviation); Unit of Measure: percent change
	80.91 (24.237)	83.06 (25.195)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 1: ABP 501, Part 1: Adalimumab
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.
Method of Estimation	Estimation Parameter	Least Squares (LS) Mean Difference
	Estimated Value	-2.18
	Confidence Interval	(2-Sided) 95%; -7.39 to 3.02
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Participants With a PASI 75 Response at Week 16
Description	A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab
Arm/Group Description:	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
Overall Number of Participants Analyzed	172	173
Measure Type: Number; Unit of Measure: percentage of participants
	74.4	82.7

3. Secondary Outcome

Title	Percentage of Participants With a PASI 75 Response at Week 32
Description	A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and week 32

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 32 are included.

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	143	72	71
Measure Type: Number; Unit of Measure: percentage of participants
	82.5	84.7	84.5

4. Secondary Outcome

Title	Percentage of Participants With a PASI 75 Response at Week 50
Description	A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and week 50

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 50 are included.

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	134	70	69
Measure Type: Number; Unit of Measure: percentage of participants
	85.1	87.1	81.2

5. Secondary Outcome

Title	Percent Improvement From Baseline in PASI at Week 32
Description	The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Time Frame	Baseline and week 32

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	143	72	71
Mean (Standard Deviation); Unit of Measure: percent change
	87.62 (18.387)	88.16 (18.181)	86.98 (16.637)

6. Secondary Outcome

Title	Percent Improvement From Baseline in PASI at Week 50
Description	The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
Time Frame	Baseline and week 50

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	134	70	69
Mean (Standard Deviation); Unit of Measure: percent change
	87.16 (19.559)	88.11 (20.957)	85.82 (21.864)

7. Secondary Outcome

Title	Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16
Description	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab
Arm/Group Description:	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
Overall Number of Participants Analyzed	172	173
Measure Type: Number; Unit of Measure: percentage of participants
	58.7	65.3

8. Secondary Outcome

Title	Percentage of Participants With a sPGA Response at Week 32
Description	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Time Frame	Week 32

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	143	72	71
Measure Type: Number; Unit of Measure: percentage of participants
	66.4	72.2	70.4

9. Secondary Outcome

Title	Percentage of Participants With a sPGA Response at Week 50
Description	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Time Frame	Week 50

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data.

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	134	70	69
Measure Type: Number; Unit of Measure: percentage of participants
	68.7	74.3	69.6

10. Secondary Outcome

Title	Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16
Description	A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Change from baseline is calculated as (value at post-baseline visit - value at baseline). A decrease from baseline (negative value) indicates improvement.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab
Arm/Group Description:	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
Overall Number of Participants Analyzed	172	173
Mean (Standard Deviation); Unit of Measure: percentage of BSA
	-18.0 (13.57)	-22.1 (17.11)

11. Secondary Outcome

Title	Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32
Description	A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Change from baseline is calculated as (value at post-baseline visit - value at baseline). A decrease from Baseline (negative value) indicates improvement.
Time Frame	Baseline and week 32

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	143	72	71
Mean (Standard Deviation); Unit of Measure: percentage of BSA
	-20.6 (13.87)	-25.3 (15.94)	-23.8 (16.17)

12. Secondary Outcome

Title	Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50
Description	A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Change from baseline is calculated as (value at post-baseline visit - value at baseline). A decrease from Baseline (negative value) indicates improvement.
Time Frame	Baseline and week 50

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	134	70	69
Mean (Standard Deviation); Unit of Measure: percentage of BSA
	-20.7 (13.58)	-25.5 (16.14)	-25.1 (17.43)

13. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. A serious AE is defined as an AE that meets at least 1 of the following serious criteria: fatal; life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups.
Time Frame	From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.

Outcome Measure Data

Analysis Population Description

The safety analysis set includes all randomized participants who received at least 1 dose of study drug, based on actual treatment received.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	174	173	152	79	77
Measure Type: Number; Unit of Measure: participants
Any adverse event (AE)	117	110	108	52	54
Grade ≥ 3 adverse event	8	5	7	2	3
Treatment-related adverse event (TRAE)	43	43	28	18	20
Grade ≥ 3 treatment-related adverse event	4	2	3	1	1
Serious adverse event (SAE)	6	5	4	4	4
Treatment-related serious adverse event	4	0	2	1	1
AE leading to discontinuation of study drug	7	5	7	1	3
TRAE leading to discontinuation of study drug	4	3	3	1	2
AE leading to discontinuation from study	7	5	4	1	2
TRAE leading to discontinuation from study	4	3	2	1	1

14. Secondary Outcome

Title	Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab
Description	Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay). Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.
Time Frame	For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.

Outcome Measure Data

Analysis Population Description

Results are reported for the anti-drug antibody analysis set (defined as the subset of participants in the Safety Analysis Set who had at least 1 evaluable antibody test) from Baseline to Week 16 for all randomized participants, and from baseline to Week 52 for participants who were re-randomized.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	174	173	152	79	77
Measure Type: Number; Unit of Measure: percentage of participants
Binding Antibody Positive	55.2	63.6	68.4	74.7	72.7
Neutralizing Antibody Positive	9.8	13.9	13.8	20.3	24.7

15. Post-Hoc Outcome

Title	Percentage of Participants With a PASI 90 Response at Week 16
Description	A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab
Arm/Group Description:	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
Overall Number of Participants Analyzed	172	173
Measure Type: Number; Unit of Measure: percentage of participants
	47.1	47.4

16. Post-Hoc Outcome

Title	Percentage of Participants With a PASI 90 Response at Week 32
Description	A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and Week 32

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	143	72	71
Measure Type: Number; Unit of Measure: percentage of participants
	62.2	65.3	57.7

17. Post-Hoc Outcome

Title	Percentage of Participants With a PASI 90 Response at Week 50
Description	A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and Week 50

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data.

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	134	70	69
Measure Type: Number; Unit of Measure: percentage of participants
	59.0	64.3	66.7

18. Post-Hoc Outcome

Title	Percentage of Participants With a PASI 100 Response at Week 16
Description	A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.

Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab
Arm/Group Description:	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
Overall Number of Participants Analyzed	172	173
Measure Type: Number; Unit of Measure: percentage of participants
	16.9	19.7

19. Post-Hoc Outcome

Title	Percentage of Participants With a PASI 100 Response at Week 32
Description	A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and Week 32

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	143	72	71
Measure Type: Number; Unit of Measure: percentage of participants
	32.9	33.3	25.4

20. Post-Hoc Outcome

Title	Percentage of Participants With a PASI 100 Response at Week 50
Description	A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame	Baseline and Week 50

Outcome Measure Data

Analysis Population Description

This analysis was performed in the re-randomized analysis set with available data.

Arm/Group Title	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description:	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed	134	70	69
Measure Type: Number; Unit of Measure: percentage of participants
	32.8	35.7	34.8

Adverse Events

Time Frame	From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Arm/Group Description	Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.	Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.	Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
All-Cause Mortality
	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--	--/--
Serious Adverse Events
	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/174 (3.45%)	5/173 (2.89%)	4/152 (2.63%)	4/79 (5.06%)	4/77 (5.19%)
Cardiac disorders
Acute myocardial infarction † 1	1/174 (0.57%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Arrhythmia † 1	1/174 (0.57%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Coronary artery disease † 1	0/174 (0.00%)	0/173 (0.00%)	1/152 (0.66%)	0/79 (0.00%)	0/77 (0.00%)
Hepatobiliary disorders
Drug-induced liver injury † 1	0/174 (0.00%)	0/173 (0.00%)	1/152 (0.66%)	0/79 (0.00%)	0/77 (0.00%)
Immune system disorders
Hypersensitivity † 1	1/174 (0.57%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Infections and infestations
Appendicitis † 1	1/174 (0.57%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Bronchitis † 1	0/174 (0.00%)	1/173 (0.58%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Diverticulitis † 1	0/174 (0.00%)	0/173 (0.00%)	1/152 (0.66%)	0/79 (0.00%)	0/77 (0.00%)
Ophthalmic herpes zoster † 1	0/174 (0.00%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	1/77 (1.30%)
Postoperative abscess † 1	1/174 (0.57%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Urinary tract infection † 1	0/174 (0.00%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	1/77 (1.30%)
Metabolism and nutrition disorders
Dyslipidaemia † 1	0/174 (0.00%)	0/173 (0.00%)	1/152 (0.66%)	0/79 (0.00%)	0/77 (0.00%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion † 1	0/174 (0.00%)	0/173 (0.00%)	0/152 (0.00%)	1/79 (1.27%)	0/77 (0.00%)
Osteoarthritis † 1	0/174 (0.00%)	1/173 (0.58%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Patellofemoral pain syndrome † 1	0/174 (0.00%)	1/173 (0.58%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Rotator cuff syndrome † 1	0/174 (0.00%)	0/173 (0.00%)	1/152 (0.66%)	0/79 (0.00%)	0/77 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna † 1	1/174 (0.57%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Nervous system disorders
Cerebral ischaemia † 1	0/174 (0.00%)	0/173 (0.00%)	1/152 (0.66%)	0/79 (0.00%)	0/77 (0.00%)
Headache † 1	0/174 (0.00%)	0/173 (0.00%)	0/152 (0.00%)	1/79 (1.27%)	0/77 (0.00%)
Migraine † 1	0/174 (0.00%)	0/173 (0.00%)	0/152 (0.00%)	1/79 (1.27%)	0/77 (0.00%)
Syncope † 1	0/174 (0.00%)	1/173 (0.58%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Transient ischaemic attack † 1	0/174 (0.00%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	1/77 (1.30%)
Psychiatric disorders
Depression † 1	0/174 (0.00%)	0/173 (0.00%)	0/152 (0.00%)	1/79 (1.27%)	0/77 (0.00%)
Reproductive system and breast disorders
Metrorrhagia † 1	0/174 (0.00%)	1/173 (0.58%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
Ovarian cyst † 1	0/174 (0.00%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	1/77 (1.30%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease † 1	1/174 (0.57%)	0/173 (0.00%)	0/152 (0.00%)	0/79 (0.00%)	0/77 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 17.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	50/174 (28.74%)	60/173 (34.68%)	48/152 (31.58%)	31/79 (39.24%)	34/77 (44.16%)
Gastrointestinal disorders
Diarrhoea † 1	2/174 (1.15%)	3/173 (1.73%)	3/152 (1.97%)	4/79 (5.06%)	8/77 (10.39%)
Infections and infestations
Nasopharyngitis † 1	25/174 (14.37%)	27/173 (15.61%)	25/152 (16.45%)	14/79 (17.72%)	18/77 (23.38%)
Upper respiratory tract infection † 1	9/174 (5.17%)	9/173 (5.20%)	9/152 (5.92%)	6/79 (7.59%)	7/77 (9.09%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	5/174 (2.87%)	7/173 (4.05%)	4/152 (2.63%)	5/79 (6.33%)	2/77 (2.60%)
Back pain † 1	7/174 (4.02%)	1/173 (0.58%)	5/152 (3.29%)	5/79 (6.33%)	1/77 (1.30%)
Nervous system disorders
Headache † 1	12/174 (6.90%)	18/173 (10.40%)	5/152 (3.29%)	8/79 (10.13%)	2/77 (2.60%)
Skin and subcutaneous tissue disorders
Psoriasis † 1	2/174 (1.15%)	2/173 (1.16%)	10/152 (6.58%)	5/79 (6.33%)	4/77 (5.19%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 17.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

Results Point of Contact

• Name/Title: Study Director
• Organization: Amgen Inc.
• Phone: 866-572-6436

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017 Dec;177(6):1562-1574. doi: 10.1111/bjd.15857. Epub 2017 Dec 1.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01970488
• Other Study ID Numbers: 20120263; 2013-000537-12 ( EudraCT Number )
• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Results First Submitted: October 20, 2016
• Results First Posted: December 13, 2016
• Last Update Posted: April 3, 2019