Trial Outcomes & Findings for Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira (NCT NCT02016105)

NCT ID: NCT02016105

Last Updated: 2017-05-30

Results Overview

The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

465 participants

Primary outcome timeframe

At Week 16 only

Results posted on

2017-05-30

Participant Flow

661 patients were screened. 465 patients were randomized 1:1 into Treatment Period 1 and stratified by region (US/EU), body weight (\<90/≥90 kg) and prior systemic therapy (no/any). In Treatment Period 2 patients were re-randomized 2:1 to either continue originally assigned treatment or switch treatment and were stratified by region only.

Screening lasted for at least 2 weeks and up to 4 weeks. Main inclusion criteria: * Men or women of at least 18 years * Chronic plaque-type psoriasis ≥ 6 months before randomization * Moderate to severe psoriasis : * PASI score ≥ 12 * IGA score ≥3 * BSA affected by plaque-type psoriasis ≥ 10% * No previous exposure to adalimumab

Participant milestones

Participant milestones
Measure	GP2017 Adalimumab Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab Switched Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	Humira ® Adalimumab Continued Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).	GP2017 Adalimumab Switched Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
TREATMENT PERIOD 1 STARTED	231	234	0	0	0	0
TREATMENT PERIOD 1 COMPLETED	201	201	0	0	0	0
TREATMENT PERIOD 1 NOT COMPLETED	30	33	0	0	0	0
TREATMENT PERIOD 2 STARTED	0	0	63	127	63	126
TREATMENT PERIOD 2 COMPLETED	0	0	57	116	59	112
TREATMENT PERIOD 2 NOT COMPLETED	0	0	6	11	4	14
EXTENSION PERIOD STARTED	0	0	52	109	56	106
EXTENSION PERIOD COMPLETED	0	0	47	104	50	100
EXTENSION PERIOD NOT COMPLETED	0	0	5	5	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	GP2017 Adalimumab Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab Switched Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	Humira ® Adalimumab Continued Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).	GP2017 Adalimumab Switched Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
TREATMENT PERIOD 1 Protocol Violation	2	8	0	0	0	0
TREATMENT PERIOD 1 Physician Decision	0	2	0	0	0	0
TREATMENT PERIOD 1 Lack of Efficacy	4	2	0	0	0	0
TREATMENT PERIOD 1 Pregnancy	0	1	0	0	0	0
TREATMENT PERIOD 1 Adverse Event	3	5	0	0	0	0
TREATMENT PERIOD 1 Withdrawal by Subject	15	11	0	0	0	0
TREATMENT PERIOD 1 Lost to Follow-up	6	4	0	0	0	0
TREATMENT PERIOD 2 Non compliance study medication	0	0	0	0	0	1
TREATMENT PERIOD 2 Lack of Efficacy	0	0	2	6	3	2
TREATMENT PERIOD 2 Pregnancy	0	0	0	0	0	1
TREATMENT PERIOD 2 Death	0	0	0	0	0	1
TREATMENT PERIOD 2 Adverse Event	0	0	0	4	0	1
TREATMENT PERIOD 2 Withdrawal by Subject	0	0	3	1	1	7
TREATMENT PERIOD 2 Lost to Follow-up	0	0	1	0	0	1
EXTENSION PERIOD New therapy for study indication	0	0	0	0	1	1
EXTENSION PERIOD Lack of Efficacy	0	0	1	3	1	1
EXTENSION PERIOD Adverse Event	0	0	2	0	1	0
EXTENSION PERIOD Withdrawal by Subject	0	0	2	2	2	2
EXTENSION PERIOD Non-compliance with study indication	0	0	0	0	1	0
EXTENSION PERIOD Lost to Follow-up	0	0	0	0	0	2

Baseline Characteristics

Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GP2017 Adalimumab n=231 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=234 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Total n=465 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	205 Participants n=5 Participants	208 Participants n=7 Participants	413 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Age, Continuous	45.6 years STANDARD_DEVIATION 14.16 • n=5 Participants	46.9 years STANDARD_DEVIATION 14.09 • n=7 Participants	46.3 years STANDARD_DEVIATION 14.12 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	92 Participants n=7 Participants	181 Participants n=5 Participants
Sex: Female, Male Male	142 Participants n=5 Participants	142 Participants n=7 Participants	284 Participants n=5 Participants
Region of Enrollment United States	188 participants n=5 Participants	190 participants n=7 Participants	378 participants n=5 Participants
Region of Enrollment Europe	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 16 only

Population: The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.

The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=197 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=196 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab	66.8 percent of participants	65.0 percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=197 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=196 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)	-60.7 percentage change from baseline Standard Error 1.54	-61.5 percentage change from baseline Standard Error 1.55	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=197 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=196 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)	-59.7 percentage change from baseline Standard Error 1.59	60.8 percentage change from baseline Standard Error 1.61	—	—

SECONDARY outcome

Timeframe: At Week 17 only

Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=197 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=196 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates % of patients achieving PASI50 at Week 17	93.2 percent of participants	92.8 percent of participants	—	—
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates % of patients achieving PASI75 at Week 17	71.4 percent of participants	68.6 percent of participants	—	—
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates % of patients achieving PASI90 at Week 17	51.6 percent of participants	44.8 percent of participants	—	—
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates % of patients achieving PASI100 at Week 17	21.9 percent of participants	16.5 percent of participants	—	—

SECONDARY outcome

Timeframe: At Week 35 only

Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=51 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=115 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched n=55 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued n=105 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
PASI 50, PASI75, PASI 90 and PASI100 Response Rates % of patients achieving PASI50 at Week 35	95.9 percent of participants	96.4 percent of participants	94.1 percent of participants	96.1 percent of participants
PASI 50, PASI75, PASI 90 and PASI100 Response Rates % of patients achieving PASI75 at Week 35	73.5 percent of participants	73.6 percent of participants	70.6 percent of participants	74.5 percent of participants
PASI 50, PASI75, PASI 90 and PASI100 Response Rates % of patients achieving PASI90 at Week 35	53.1 percent of participants	52.7 percent of participants	62.7 percent of participants	61.8 percent of participants
PASI 50, PASI75, PASI 90 and PASI100 Response Rates % of patients achieving PASI100 at Week 35	28.6 percent of participants	30.9 percent of participants	35.3 percent of participants	33.3 percent of participants

SECONDARY outcome

Timeframe: At Week 51 only

Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=51 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=115 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched n=55 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued n=105 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
PASI 50, PASI75, PASI 90 and PASI100 Response Rates % of patients achieving PASI50 at Week 51	95.3 percent of participants	93.9 percent of participants	87.5 percent of participants	95.9 percent of participants
PASI 50, PASI75, PASI 90 and PASI100 Response Rates % of patients achieving PASI75 at Week 51	76.7 percent of participants	79.6 percent of participants	75.0 percent of participants	84.5 percent of participants
PASI 50, PASI75, PASI 90 and PASI100 Response Rates % of patients achieving PASI90 at Week 51	48.8 percent of participants	51.0 percent of participants	60.4 percent of participants	62.9 percent of participants
PASI 50, PASI75, PASI 90 and PASI100 Response Rates % of patients achieving PASI100 at Week 51	25.6 percent of participants	29.6 percent of participants	31.3 percent of participants	35.1 percent of participants

SECONDARY outcome

Timeframe: At Week 17 only

Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 17.

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=197 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=196 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
IGA Response Rate	53.6 percent of participants	53.6 percent of participants	—	—

SECONDARY outcome

Timeframe: At Week 35 only

Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=51 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=115 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched n=55 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued n=105 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
IGA Response Rate	59.2 percent of participants	58.2 percent of participants	58.8 percent of participants	58.8 percent of participants

SECONDARY outcome

Timeframe: At Week 51 only

Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=51 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=115 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched n=55 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued n=105 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
IGA Response Rate	46.5 percent of participants	55.1 percent of participants	58.3 percent of participants	59.8 percent of participants

SECONDARY outcome

Timeframe: At Week 17 only

Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=197 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=196 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
DLQI	50.5 % of patients with DLQI of 0 or 1	48.4 % of patients with DLQI of 0 or 1	—	—

SECONDARY outcome

Timeframe: At Week 35 only

Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=51 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=115 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched n=55 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued n=105 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
DLQI	49.0 % of patients with DLQI of 0 or 1	54.5 % of patients with DLQI of 0 or 1	52.9 % of patients with DLQI of 0 or 1	55.9 % of patients with DLQI of 0 or 1

SECONDARY outcome

Timeframe: At Week 51 only

Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=51 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=115 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched n=55 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued n=105 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
DLQI	48.8 % of patients with DLQI of 0 or 1	55.6 % of patients with DLQI of 0 or 1	54.2 % of patients with DLQI of 0 or 1	59.8 % of patients with DLQI of 0 or 1

SECONDARY outcome

Timeframe: At Week 17 only

Population: The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.

Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17. Patients with ADA positive results at baseline were excluded from subsequent results.

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=231 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=234 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17	36.8 % patients with at least 1 ADA+ sample	34.1 % patients with at least 1 ADA+ sample	—	—

SECONDARY outcome

Timeframe: At Week 51 only

Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51. Patients with ADA positive results at baseline were excluded from subsequent results.

Outcome measures

Outcome measures
Measure	GP2017 Adalimumab n=63 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	Humira ® Adalimumab n=127 Participants Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).	GP2017 Adalimumab Switched n=63 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued n=126 Participants GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51	39.3 % patients with at least 1 ADA+ sample	45.1 % patients with at least 1 ADA+ sample	46.7 % patients with at least 1 ADA+ sample	35.8 % patients with at least 1 ADA+ sample

Adverse Events

Humira ® Adalimumab Switched

Serious events: 6 serious events

Other events: 40 other events

Deaths: 0 deaths

Humira ® Adalimumab Continued

Serious events: 10 serious events

Other events: 85 other events

Deaths: 0 deaths

GP2017 Adalimumab Switched

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

GP2017 Adalimumab Continued

Serious events: 4 serious events

Other events: 84 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Global Program Medical Director

Sandoz

Phone: +49 8024 476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.
Publication restrictions are in place

Restriction type: OTHER

Measure	Humira ® Adalimumab Switched n=63 participants at risk Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	Humira ® Adalimumab Continued n=127 participants at risk Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.	GP2017 Adalimumab Switched n=63 participants at risk GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35). GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).	GP2017 Adalimumab Continued n=126 participants at risk GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Infections and infestations Pneumonia	3.2% 2/63 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Infections and infestations Pneumonia necrotizing	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Infections and infestations Pulmonary tuberculosis	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Infections and infestations Pyelonephritis	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/126 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Infections and infestations Sepsis	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.6% 1/63 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	1.6% 1/63 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/126 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	1.6% 1/63 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
General disorders Chest pain	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
General disorders Non-cardiac chest pain	1.6% 1/63 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
General disorders Pyrexia	1.6% 1/63 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
General disorders Swelling	1.6% 1/63 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Psychiatric disorders Completed suicide	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/126 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Psychiatric disorders Schizoaffective disorder	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	1.6% 1/63 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Psychiatric disorders Suicide attempt	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Cardiac disorders Cardiomyopathy	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/126 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Cardiac disorders Coronary artery disease	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Gastrointestinal disorders Abdominall pain	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Gastrointestinal disorders Vomiting	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Renal and urinary disorders Renal colic	1.6% 1/63 • Number of events 2 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Renal and urinary disorders Renal haematoma	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Musculoskeletal and connective tissue disorders Joint effusion	1.6% 1/63 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/127 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.79% 1/127 • Number of events 1 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/63 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)	0.00% 0/126 • Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)