Trial Outcomes & Findings for Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis (NCT NCT01970488)

NCT ID: NCT01970488

Last Updated: 2019-04-03

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 350 participants
• Primary outcome timeframe: Baseline and Week 16
• Results posted on: 2019-04-03

Participant Flow

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.

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.

Participant milestones

Measure	Part 1: ABP 501 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.	Part 1: Adalimumab 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.	Part 2: ABP 501/ABP 501 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Part 1: Through Week 16 STARTED	175	175	0	0	0
Part 1: Through Week 16 Received Treatment	174	173	0	0	0
Part 1: Through Week 16 COMPLETED	164	162	0	0	0
Part 1: Through Week 16 NOT COMPLETED	11	13	0	0	0
Part 2: Post Week 16 STARTED	0	0	152	79	77
Part 2: Post Week 16 COMPLETED	0	0	135	71	69
Part 2: Post Week 16 NOT COMPLETED	0	0	17	8	8

Reasons for withdrawal

Measure	Part 1: ABP 501 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.	Part 1: Adalimumab 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.	Part 2: ABP 501/ABP 501 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Part 1: Through Week 16 Protocol-specified Criteria	1	2	0	0	0
Part 1: Through Week 16 Protocol Violation	1	2	0	0	0
Part 1: Through Week 16 Adverse Event	6	5	0	0	0
Part 1: Through Week 16 Withdrawal by Subject	3	2	0	0	0
Part 1: Through Week 16 Lost to Follow-up	0	2	0	0	0
Part 2: Post Week 16 Physician Decision	0	0	0	0	1
Part 2: Post Week 16 Non-compliance	0	0	1	0	0
Part 2: Post Week 16 Lack of Efficacy	0	0	2	3	1
Part 2: Post Week 16 Adverse Event	0	0	5	1	1
Part 2: Post Week 16 Withdrawal by Subject	0	0	8	3	3
Part 2: Post Week 16 Lost to Follow-up	0	0	1	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Part 1: ABP 501 n=175 Participants 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.	Part 1: Adalimumab n=175 Participants 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 n=350 Participants Total of all reporting groups
Age, Continuous	45.1 years STANDARD_DEVIATION 12.95 • n=93 Participants	44.0 years STANDARD_DEVIATION 13.68 • n=4 Participants	44.6 years STANDARD_DEVIATION 13.31 • n=27 Participants
Age, Customized < 65 years	164 participants n=93 Participants	163 participants n=4 Participants	327 participants n=27 Participants
Age, Customized ≥ 65 years	11 participants n=93 Participants	12 participants n=4 Participants	23 participants n=27 Participants
Sex: Female, Male Female	63 Participants n=93 Participants	59 Participants n=4 Participants	122 Participants n=27 Participants
Sex: Female, Male Male	112 Participants n=93 Participants	116 Participants n=4 Participants	228 Participants n=27 Participants
Race/Ethnicity, Customized White	167 participants n=93 Participants	157 participants n=4 Participants	324 participants n=27 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants
Race/Ethnicity, Customized Asian	5 participants n=93 Participants	8 participants n=4 Participants	13 participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized Mixed Race	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized Other	1 participants n=93 Participants	3 participants n=4 Participants	4 participants n=27 Participants
Race/Ethnicity, Customized Unknown	2 participants n=93 Participants	3 participants n=4 Participants	5 participants n=27 Participants
Prior Biological Use for Psoriasis Yes	33 participants n=93 Participants	30 participants n=4 Participants	63 participants n=27 Participants
Prior Biological Use for Psoriasis No	142 participants n=93 Participants	145 participants n=4 Participants	287 participants n=27 Participants
Geographic Region Eastern Europe	71 participants n=93 Participants	70 participants n=4 Participants	141 participants n=27 Participants
Geographic Region Western Europe	43 participants n=93 Participants	43 participants n=4 Participants	86 participants n=27 Participants
Geographic Region Other	61 participants n=93 Participants	62 participants n=4 Participants	123 participants n=27 Participants
Static Physician's Global Assessment (sPGA) Clear	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Static Physician's Global Assessment (sPGA) Almost Clear	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Static Physician's Global Assessment (sPGA) Mild	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Static Physician's Global Assessment (sPGA) Moderate	106 participants n=93 Participants	102 participants n=4 Participants	208 participants n=27 Participants
Static Physician's Global Assessment (sPGA) Severe	61 participants n=93 Participants	61 participants n=4 Participants	122 participants n=27 Participants
Static Physician's Global Assessment (sPGA) Very Severe	7 participants n=93 Participants	10 participants n=4 Participants	17 participants n=27 Participants
Static Physician's Global Assessment (sPGA) Missing	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants
Psoriasis Area and Severity Index (PASI) Score	19.68 units on a scale STANDARD_DEVIATION 8.100 • n=93 Participants	20.48 units on a scale STANDARD_DEVIATION 7.880 • n=4 Participants	20.08 units on a scale STANDARD_DEVIATION 7.990 • n=27 Participants
Body Surface Area (BSA) Affected by Psoriasis	25.3 percentage of BSA STANDARD_DEVIATION 15.02 • n=93 Participants	28.5 percentage of BSA STANDARD_DEVIATION 16.82 • n=4 Participants	26.9 percentage of BSA STANDARD_DEVIATION 16.00 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: 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.

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).

Outcome measures

Measure	Part 1: ABP 501 n=172 Participants 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.	Part 1: Adalimumab n=173 Participants 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.	Part 2: Adalimumab/ABP 501 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16	80.91 percent change Standard Deviation 24.237	83.06 percent change Standard Deviation 25.195	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 16

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=172 Participants 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.	Part 1: Adalimumab n=173 Participants 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.	Part 2: Adalimumab/ABP 501 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 75 Response at Week 16	74.4 percentage of participants	82.7 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 32

Population: 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.

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.

Outcome measures

Measure	Part 1: ABP 501 n=143 Participants 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.	Part 1: Adalimumab n=72 Participants 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.	Part 2: Adalimumab/ABP 501 n=71 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 75 Response at Week 32	82.5 percentage of participants	84.7 percentage of participants	84.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and week 50

Population: 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.

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.

Outcome measures

Measure	Part 1: ABP 501 n=134 Participants 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.	Part 1: Adalimumab n=70 Participants 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.	Part 2: Adalimumab/ABP 501 n=69 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 75 Response at Week 50	85.1 percentage of participants	87.1 percentage of participants	81.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and week 32

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

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).

Outcome measures

Measure	Part 1: ABP 501 n=143 Participants 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.	Part 1: Adalimumab n=72 Participants 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.	Part 2: Adalimumab/ABP 501 n=71 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percent Improvement From Baseline in PASI at Week 32	87.62 percent change Standard Deviation 18.387	88.16 percent change Standard Deviation 18.181	86.98 percent change Standard Deviation 16.637	—	—

SECONDARY outcome

Timeframe: Baseline and week 50

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

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).

Outcome measures

Measure	Part 1: ABP 501 n=134 Participants 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.	Part 1: Adalimumab n=70 Participants 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.	Part 2: Adalimumab/ABP 501 n=69 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percent Improvement From Baseline in PASI at Week 50	87.16 percent change Standard Deviation 19.559	88.11 percent change Standard Deviation 20.957	85.82 percent change Standard Deviation 21.864	—	—

SECONDARY outcome

Timeframe: Week 16

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

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).

Outcome measures

Measure	Part 1: ABP 501 n=172 Participants 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.	Part 1: Adalimumab n=173 Participants 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.	Part 2: Adalimumab/ABP 501 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16	58.7 percentage of participants	65.3 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Week 32

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

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).

Outcome measures

Measure	Part 1: ABP 501 n=143 Participants 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.	Part 1: Adalimumab n=72 Participants 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.	Part 2: Adalimumab/ABP 501 n=71 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a sPGA Response at Week 32	66.4 percentage of participants 18.387	72.2 percentage of participants 18.181	70.4 percentage of participants 16.637	—	—

SECONDARY outcome

Timeframe: Week 50

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

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).

Outcome measures

Measure	Part 1: ABP 501 n=134 Participants 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.	Part 1: Adalimumab n=70 Participants 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.	Part 2: Adalimumab/ABP 501 n=69 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a sPGA Response at Week 50	68.7 percentage of participants	74.3 percentage of participants	69.6 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 16

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=172 Participants 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.	Part 1: Adalimumab n=173 Participants 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.	Part 2: Adalimumab/ABP 501 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16	-18.0 percentage of BSA Standard Deviation 13.57	-22.1 percentage of BSA Standard Deviation 17.11	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 32

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=143 Participants 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.	Part 1: Adalimumab n=72 Participants 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.	Part 2: Adalimumab/ABP 501 n=71 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32	-20.6 percentage of BSA Standard Deviation 13.87	-25.3 percentage of BSA Standard Deviation 15.94	-23.8 percentage of BSA Standard Deviation 16.17	—	—

SECONDARY outcome

Timeframe: Baseline and week 50

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=134 Participants 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.	Part 1: Adalimumab n=70 Participants 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.	Part 2: Adalimumab/ABP 501 n=69 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50	-20.7 percentage of BSA Standard Deviation 13.58	-25.5 percentage of BSA Standard Deviation 16.14	-25.1 percentage of BSA Standard Deviation 17.43	—	—

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=174 Participants 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.	Part 1: Adalimumab n=173 Participants 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.	Part 2: Adalimumab/ABP 501 n=152 Participants 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.	Part 2: Adalimumab/Adalimumab n=79 Participants 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.	Part 2: Adalimumab/ABP 501 n=77 Participants 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.
Number of Participants With Adverse Events Any adverse event (AE)	117 participants	110 participants	108 participants	52 participants	54 participants
Number of Participants With Adverse Events Grade ≥ 3 adverse event	8 participants	5 participants	7 participants	2 participants	3 participants
Number of Participants With Adverse Events Treatment-related adverse event (TRAE)	43 participants	43 participants	28 participants	18 participants	20 participants
Number of Participants With Adverse Events Grade ≥ 3 treatment-related adverse event	4 participants	2 participants	3 participants	1 participants	1 participants
Number of Participants With Adverse Events Serious adverse event (SAE)	6 participants	5 participants	4 participants	4 participants	4 participants
Number of Participants With Adverse Events Treatment-related serious adverse event	4 participants	0 participants	2 participants	1 participants	1 participants
Number of Participants With Adverse Events AE leading to discontinuation of study drug	7 participants	5 participants	7 participants	1 participants	3 participants
Number of Participants With Adverse Events TRAE leading to discontinuation of study drug	4 participants	3 participants	3 participants	1 participants	2 participants
Number of Participants With Adverse Events AE leading to discontinuation from study	7 participants	5 participants	4 participants	1 participants	2 participants
Number of Participants With Adverse Events TRAE leading to discontinuation from study	4 participants	3 participants	2 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.

Population: 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.

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.

Outcome measures

Measure	Part 1: ABP 501 n=174 Participants 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.	Part 1: Adalimumab n=173 Participants 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.	Part 2: Adalimumab/ABP 501 n=152 Participants 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.	Part 2: Adalimumab/Adalimumab n=79 Participants 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.	Part 2: Adalimumab/ABP 501 n=77 Participants 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.
Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab Binding Antibody Positive	55.2 percentage of participants	63.6 percentage of participants	68.4 percentage of participants	74.7 percentage of participants	72.7 percentage of participants
Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab Neutralizing Antibody Positive	9.8 percentage of participants	13.9 percentage of participants	13.8 percentage of participants	20.3 percentage of participants	24.7 percentage of participants

POST_HOC outcome

Timeframe: Baseline and Week 16

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=172 Participants 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.	Part 1: Adalimumab n=173 Participants 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.	Part 2: Adalimumab/ABP 501 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 90 Response at Week 16	47.1 percentage of participants	47.4 percentage of participants	—	—	—

POST_HOC outcome

Timeframe: Baseline and Week 32

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=143 Participants 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.	Part 1: Adalimumab n=72 Participants 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.	Part 2: Adalimumab/ABP 501 n=71 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 90 Response at Week 32	62.2 percentage of participants 18.387	65.3 percentage of participants 18.181	57.7 percentage of participants 16.637	—	—

POST_HOC outcome

Timeframe: Baseline and Week 50

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=134 Participants 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.	Part 1: Adalimumab n=70 Participants 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.	Part 2: Adalimumab/ABP 501 n=69 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 90 Response at Week 50	59.0 percentage of participants	64.3 percentage of participants	66.7 percentage of participants	—	—

POST_HOC outcome

Timeframe: Baseline and Week 16

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=172 Participants 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.	Part 1: Adalimumab n=173 Participants 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.	Part 2: Adalimumab/ABP 501 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 100 Response at Week 16	16.9 percentage of participants	19.7 percentage of participants	—	—	—

POST_HOC outcome

Timeframe: Baseline and Week 32

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=143 Participants 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.	Part 1: Adalimumab n=72 Participants 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.	Part 2: Adalimumab/ABP 501 n=71 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 100 Response at Week 32	32.9 percentage of participants 18.387	33.3 percentage of participants 18.181	25.4 percentage of participants 16.637	—	—

POST_HOC outcome

Timeframe: Baseline and Week 50

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

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.

Outcome measures

Measure	Part 1: ABP 501 n=134 Participants 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.	Part 1: Adalimumab n=70 Participants 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.	Part 2: Adalimumab/ABP 501 n=69 Participants 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.	Part 2: Adalimumab/Adalimumab 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.	Part 2: Adalimumab/ABP 501 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.
Percentage of Participants With a PASI 100 Response at Week 50	32.8 percentage of participants	35.7 percentage of participants	34.8 percentage of participants	—	—

Adverse Events

Part 1: ABP 501

Serious events: 6 serious events

Other events: 50 other events

Deaths: 0 deaths

Part 1: Adalimumab

Serious events: 5 serious events

Other events: 60 other events

Deaths: 0 deaths

Part 2: ABP 501/ABP 501

Serious events: 4 serious events

Other events: 48 other events

Deaths: 0 deaths

Part 2: Adalimumab/Adalimumab

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Part 2: Adalimumab/ABP 501

Serious events: 4 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: ABP 501 n=174 participants at risk 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.	Part 1: Adalimumab n=173 participants at risk 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.	Part 2: ABP 501/ABP 501 n=152 participants at risk 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.	Part 2: Adalimumab/Adalimumab n=79 participants at risk 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.	Part 2: Adalimumab/ABP 501 n=77 participants at risk 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.
Nervous system disorders Migraine	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Syncope	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.58% 1/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient ischaemic attack	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.58% 1/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute myocardial infarction	0.57% 1/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arrhythmia	0.57% 1/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.66% 1/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.66% 1/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Hypersensitivity	0.57% 1/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis	0.57% 1/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.58% 1/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Diverticulitis	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.66% 1/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Postoperative abscess	0.57% 1/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.66% 1/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.58% 1/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.58% 1/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.66% 1/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.57% 1/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral ischaemia	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.66% 1/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.00% 0/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.57% 1/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Part 1: ABP 501 n=174 participants at risk 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.	Part 1: Adalimumab n=173 participants at risk 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.	Part 2: ABP 501/ABP 501 n=152 participants at risk 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.	Part 2: Adalimumab/Adalimumab n=79 participants at risk 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.	Part 2: Adalimumab/ABP 501 n=77 participants at risk 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.
Gastrointestinal disorders Diarrhoea	1.1% 2/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 3/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.0% 3/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.4% 8/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	14.4% 25/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.6% 27/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.4% 25/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	17.7% 14/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	23.4% 18/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	5.2% 9/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.2% 9/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 9/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.6% 6/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 7/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 5/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.0% 7/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 4/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.3% 5/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	4.0% 7/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.58% 1/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.3% 5/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.3% 5/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	6.9% 12/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.4% 18/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.3% 5/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.1% 8/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Psoriasis	1.1% 2/174 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.2% 2/173 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.6% 10/152 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.3% 5/79 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.2% 4/77 • 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. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER