Trial Outcomes & Findings for A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis (NCT NCT05073315)

Results Overview

Participants analyzed according to actual treatment received.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

425 participants

Primary outcome timeframe

Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

Results posted on

2024-02-09

Participant Flow

A total of 425 participants were enrolled in the study at 83 centers across 6 countries (Canada, Estonia, Germany, Latvia, Poland, and the US) between October 2021 and December 2022.

Participants were enrolled in Period 1 of the study (Lead-in Period) and received adalimumab (Humira®) subcutaneously (SC) during a 12-week period. Participants who responded to treatment during Period 1 (achieving PASI ≥ 50) were randomized in Period 2 to either the Continued-use Group or the Switching Group. Period 2 lasted 20 weeks from Week 12 to Week 32.

Participant milestones

Participant milestones
Measure	Period 1 (Lead-in Period) Participants with plaque psoriasis (Ps) received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 \[80 mg\], Week 2/Day 8 \[40 mg\], Week 4, Week 6, Week 8, and Week 10 \[40 mg\]) during the Lead-in Period.	Period 2 (Switching Group) Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Period 1 (Lead-in Period) STARTED	425	0	0
Period 1 (Lead-in Period) COMPLETED	380	0	0
Period 1 (Lead-in Period) NOT COMPLETED	45	0	0
Period 2 STARTED	0	186	194
Period 2 COMPLETED	0	174	173
Period 2 NOT COMPLETED	0	12	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Period 1 (Lead-in Period) Participants with plaque psoriasis (Ps) received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 \[80 mg\], Week 2/Day 8 \[40 mg\], Week 4, Week 6, Week 8, and Week 10 \[40 mg\]) during the Lead-in Period.	Period 2 (Switching Group) Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Period 1 (Lead-in Period) Adverse Event	6	0	0
Period 1 (Lead-in Period) Death	1	0	0
Period 1 (Lead-in Period) Withdrawal by Subject	6	0	0
Period 1 (Lead-in Period) Lost to Follow-up	3	0	0
Period 1 (Lead-in Period) Protocol Violation	5	0	0
Period 1 (Lead-in Period) Did not Meet PASI 50 at Week 12	23	0	0
Period 1 (Lead-in Period) Lack of Efficacy	1	0	0
Period 2 Adverse Event	0	3	6
Period 2 Lost to Follow-up	0	5	5
Period 2 Withdrawal by Subject	0	4	9
Period 2 Protocol Violation	0	0	1

Baseline Characteristics

A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Period 2 (Switching Group) n=186 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=194 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.	Total n=380 Participants Total of all reporting groups
Age, Continuous	44.9 Years STANDARD_DEVIATION 13.27 • n=5 Participants	44.3 Years STANDARD_DEVIATION 13.91 • n=7 Participants	44.6 Years STANDARD_DEVIATION 13.59 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	63 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants	131 Participants n=7 Participants	261 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	36 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants	158 Participants n=7 Participants	316 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	162 Participants n=5 Participants	172 Participants n=7 Participants	334 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 28 pre-dose and 1hour, 1 day, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

Population: The Pharmacokinetic (PK) Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between Weeks 28 and 30.

Participants analyzed according to actual treatment received.

Outcome measures

Outcome measures
Measure	Period 2 (Switching Group) n=146 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=145 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Area Under the Curve From Time 0 Over the Dosing Interval (AUCtau) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	1458.03 hr*μg/mL Geometric Coefficient of Variation 156.6	1472.68 hr*μg/mL Geometric Coefficient of Variation 174.9

PRIMARY outcome

Timeframe: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

Population: The PK Parameter Analysis Set consists of all randomized participants who receive at least one dose post-randomization and who have an evaluable ABP 501 or adalimumab serum concentration-time profile between weeks 28 and 30.

Participants analyzed according to treatment received.

Outcome measures

Outcome measures
Measure	Period 2 (Switching Group) n=153 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=153 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Maximum Serum Concentration (Cmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	4.91 μg/mL Geometric Coefficient of Variation 153.6	5.01 μg/mL Geometric Coefficient of Variation 160.4

SECONDARY outcome

Timeframe: Week 28 pre-dose, 1h post Week 28 dose, 1 day post Week 28 dose, 3 days, 4 days, 7 days, 11 days, and 14 days post Week 28 dose

Population: The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of investigational product (IP) post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization.

Time to reach maximum serum concentration.

Outcome measures

Outcome measures
Measure	Period 2 (Switching Group) n=162 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=160 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Time to Reach Maximum Serum Concentration (Tmax) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group)	72.30 Hours Interval 0.0 to 266.5	72.35 Hours Interval 0.0 to 334.9

SECONDARY outcome

Timeframe: Pre-dose at Week 12, Week 16, Week 20, and Week 28

Population: The analyses of the secondary PK endpoints is based on the PK Concentration Analysis Set, which included all randomized participants who received at least 1 dose of IP post-randomization and had at least 1 reported serum concentration of ABP 501 or adalimumab on or after the day of randomization. All participants reported in the overall number of participants analyzed contributed data to this analysis.

Outcome measures

Outcome measures
Measure	Period 2 (Switching Group) n=162 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=160 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Week 12	4528.7316 ng/mL Geometric Coefficient of Variation 88.9	4072.5556 ng/mL Geometric Coefficient of Variation 119.0
Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Week 16	4046.3069 ng/mL Geometric Coefficient of Variation 144.1	3682.0016 ng/mL Geometric Coefficient of Variation 188.1
Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Week 20	4113.0839 ng/mL Geometric Coefficient of Variation 160.8	4332.1272 ng/mL Geometric Coefficient of Variation 148.9
Trough Concentration (Ctrough) of ABP 501 (Switching Group) and Adalimumab (Continued-use Group) Week 28	3736.9917 ng/mL Geometric Coefficient of Variation 182.1	4014.4980 ng/mL Geometric Coefficient of Variation 193.5

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 30

Population: Based on the per-protocol (PP) efficacy analysis set as observed, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

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

Outcome measures
Measure	Period 2 (Switching Group) n=151 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=151 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
PASI Percent Improvement From Baseline (Day 1) to Week 30	88.56 Percentage Change Interval 86.07 to 91.05	91.01 Percentage Change Interval 88.76 to 93.26

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 30

Population: Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

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

Outcome measures
Measure	Period 2 (Switching Group) n=151 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=151 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Number of Participants Achieving PASI 75 Response at Week 30	131 Participants	134 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 30

Population: Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

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

Outcome measures
Measure	Period 2 (Switching Group) n=151 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=151 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Number of Participants Achieving PASI 90 Response at Week 30	92 Participants	108 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 30

Population: Based on the PP efficacy analysis set, which consisted of all participants who were randomized and received all assigned doses post randomization and who had not experienced an important protocol deviation that could affect the efficacy endpoints; used for primary analysis of the secondary efficacy endpoints; analyzed according to actual treatment received.

A PASI 100 response is a 100% 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

Outcome measures
Measure	Period 2 (Switching Group) n=151 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=151 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Number of Participants Achieving PASI 100 Response at Week 30	52 Participants	61 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 32

Population: Population from the Safety Analysis Set (SAS). Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

Outcome measures

Outcome measures
Measure	Period 2 (Switching Group) n=186 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=194 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) TEAE	97 Participants	106 Participants
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) Serious TEAE	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 32

Population: Population from the SAS. Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

An EOI is defined as a noteworthy event for a particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals.

Outcome measures

Outcome measures
Measure	Period 2 (Switching Group) n=186 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=194 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Number of Participants Experiencing Events of Interest (EOI)	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Week 16, Week 20, Week 28, Week 30, and Week 32

Population: Population from the SAS. Population consisted of participants who were randomized and received at least 1 dose of IP post randomization; used for analyses of the safety endpoints during the Post-randomization Period; analyzed according to actual treatment received.

Anti-drug antibody samples were drawn prior to investigational product administration at dosing visits.

Outcome measures

Outcome measures
Measure	Period 2 (Switching Group) n=186 Participants Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).	Period 2 (Continued-use Group) n=194 Participants Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Participants with a post-randomization result	186 Participants	194 Participants
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Binding antibody negative or no result prior to the first dose of post-randomization IP	25 Participants	18 Participants
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Binding antibody positive with negative/no result prior to first dose post-randomization	16 Participants	10 Participants
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Transient binding antibody positive with negative/no result prior to first dose post-randomization	3 Participants	2 Participants
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Neutralizing antibody negative or no result prior to the first dose of post-randomization IP	174 Participants	182 Participants
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Neutralizing antibody positive with negative/no result prior to first dose post-randomization	21 Participants	27 Participants
Number of Participants With Anti-drug Antibodies (ADA) Expression Post Randomization Transient neutralizing antibody positive with negative/no result prior first dose post-randomization	2 Participants	3 Participants

Adverse Events

Period 1 (Lead-in Period)

Serious events: 5 serious events

Other events: 38 other events

Deaths: 1 deaths

Period 2 (Continued-use Group)

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Period 2 (Switching Group)

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Period 1 (Lead-in Period) n=425 participants at risk Participants with Ps received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 \[80 mg\], Week 2/Day 8 \[40 mg\], Week 4, Week 6, Week 8, and Week 10 \[40 mg\]) during the Lead-in Period.	Period 2 (Continued-use Group) n=194 participants at risk Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.	Period 2 (Switching Group) n=186 participants at risk Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).
Infections and infestations COVID-19	3.3% 14/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.6% 7/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	7.0% 13/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	2.8% 12/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.7% 11/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	7.0% 13/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	3.8% 16/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.7% 13/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.2% 4/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

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

Measure	Period 1 (Lead-in Period) n=425 participants at risk Participants with Ps received adalimumab 100 mg/mL SC from Week 1 to Week 12 for a total of 6 doses (Week 1/Day 1 \[80 mg\], Week 2/Day 8 \[40 mg\], Week 4, Week 6, Week 8, and Week 10 \[40 mg\]) during the Lead-in Period.	Period 2 (Continued-use Group) n=194 participants at risk Participants with Ps who responded to treatment achieving PASI ≥ 50 in Period 1, were randomised to the Continued-use Group from Week 12 to Week 32 in Period 2 of the study. Participants continued receiving adalimumab 40 mg Q2W.	Period 2 (Switching Group) n=186 participants at risk Participants with Ps who responded to treatment, defined as achieving PASI ≥ 50 in Period 1, were randomised to the Switching Group from Week 12 to Week 32 in Period 2 of the study. Participants received ABP 501 Q2W (Week 12 and Week 14 \[40 mg\]), adalimumab Q2W (Week 16 and Week 18 \[40 mg\]), and ABP 501 Q2W again (Week 20, Week 22, Week 24, Week 26, Week 28 \[40 mg\]).
Gastrointestinal disorders Abdominal pain	0.24% 1/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Alcoholic pancreatitis	0.00% 0/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.54% 1/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.52% 1/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Death	0.24% 1/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.52% 1/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tuberculosis	0.00% 0/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.52% 1/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.54% 1/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.24% 1/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.24% 1/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.24% 1/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Central nervous system lesion	0.24% 1/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Facial paralysis	0.24% 1/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Trigeminal nerve disorder	0.24% 1/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.52% 1/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/425 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/194 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.54% 1/186 • Baseline up to 32 weeks All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.