Plaque Type Psoriasis
Conditions
Keywords
plaque type psoriasis, equivalent efficacy, safety and immunogenicity, GP2017, Humira®
Brief summary
The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.
Detailed description
The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment. The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.
Interventions
DRUGGP2017 Adalimumab
DRUGHumira ® Adalimumab
Sponsors
Hexal AG
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women at least 18 years of age at time of screening * Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization * Moderate to severe psoriasis as defined at baseline by: * PASI score of 12 or greater * Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and, * Body Surface Area affected by plaque-type psoriasis of 10% or greater * Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.
Exclusion criteria
* Forms of psoriasis other than chronic plaque-type * Drug-induced psoriasis * Ongoing use of prohibited psoriasis treatments * Previous exposure to adalimumab * Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab Other In-/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab | At Week 16 only | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA) | 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). |
| PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | At Week 17 only | Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1) |
| PASI 50, PASI75, PASI 90 and PASI100 Response Rates | At Week 35 only | Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2) |
| Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM) | 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. |
| DLQI | At Week 17 only | Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life) |
| ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17 | At Week 17 only | 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. |
| ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 | 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. |
| IGA Response Rate | 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. |
Countries
Bulgaria, France, Slovakia, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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). | 231 |
| 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). | 234 |
| Total | 465 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| EXTENSION PERIOD | Adverse Event | 0 | 0 | 2 | 0 | 1 | 0 |
| EXTENSION PERIOD | Lack of Efficacy | 0 | 0 | 1 | 3 | 1 | 1 |
| EXTENSION PERIOD | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 2 |
| EXTENSION PERIOD | New therapy for study indication | 0 | 0 | 0 | 0 | 1 | 1 |
| EXTENSION PERIOD | Non-compliance with study indication | 0 | 0 | 0 | 0 | 1 | 0 |
| EXTENSION PERIOD | Withdrawal by Subject | 0 | 0 | 2 | 2 | 2 | 2 |
| TREATMENT PERIOD 1 | Adverse Event | 3 | 5 | 0 | 0 | 0 | 0 |
| TREATMENT PERIOD 1 | Lack of Efficacy | 4 | 2 | 0 | 0 | 0 | 0 |
| TREATMENT PERIOD 1 | Lost to Follow-up | 6 | 4 | 0 | 0 | 0 | 0 |
| TREATMENT PERIOD 1 | Physician Decision | 0 | 2 | 0 | 0 | 0 | 0 |
| TREATMENT PERIOD 1 | Pregnancy | 0 | 1 | 0 | 0 | 0 | 0 |
| TREATMENT PERIOD 1 | Protocol Violation | 2 | 8 | 0 | 0 | 0 | 0 |
| TREATMENT PERIOD 1 | Withdrawal by Subject | 15 | 11 | 0 | 0 | 0 | 0 |
| TREATMENT PERIOD 2 | Adverse Event | 0 | 0 | 0 | 4 | 0 | 1 |
| TREATMENT PERIOD 2 | Death | 0 | 0 | 0 | 0 | 0 | 1 |
| TREATMENT PERIOD 2 | Lack of Efficacy | 0 | 0 | 2 | 6 | 3 | 2 |
| TREATMENT PERIOD 2 | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 1 |
| TREATMENT PERIOD 2 | Non compliance study medication | 0 | 0 | 0 | 0 | 0 | 1 |
| TREATMENT PERIOD 2 | Pregnancy | 0 | 0 | 0 | 0 | 0 | 1 |
| TREATMENT PERIOD 2 | Withdrawal by Subject | 0 | 0 | 3 | 1 | 1 | 7 |
Baseline characteristics
| Characteristic | GP2017 Adalimumab | Humira ® Adalimumab | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 26 Participants | 52 Participants |
| Age, Categorical Between 18 and 65 years | 205 Participants | 208 Participants | 413 Participants |
| Age, Continuous | 45.6 years STANDARD_DEVIATION 14.16 | 46.9 years STANDARD_DEVIATION 14.09 | 46.3 years STANDARD_DEVIATION 14.12 |
| Region of Enrollment Europe | 43 participants | 44 participants | 87 participants |
| Region of Enrollment United States | 188 participants | 190 participants | 378 participants |
| Sex: Female, Male Female | 89 Participants | 92 Participants | 181 Participants |
| Sex: Female, Male Male | 142 Participants | 142 Participants | 284 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 127 | 0 / 63 | 1 / 126 |
| other Total, other adverse events | 40 / 63 | 85 / 127 | 47 / 63 | 84 / 126 |
| serious Total, serious adverse events | 6 / 63 | 10 / 127 | 2 / 63 | 4 / 126 |
Outcome results
Primary
PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab | 66.8 percent of participants |
| Humira ® Adalimumab | PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab | 65.0 percent of participants |
95% CI: [-7.46, 11.15]
Secondary
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17 | 36.8 % patients with at least 1 ADA+ sample |
| Humira ® Adalimumab | ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17 | 34.1 % patients with at least 1 ADA+ sample |
Secondary
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51
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.
Time frame: At Week 51 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 | 39.3 % patients with at least 1 ADA+ sample |
| Humira ® Adalimumab | ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 | 45.1 % patients with at least 1 ADA+ sample |
| GP2017 Adalimumab Switched | ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 | 46.7 % patients with at least 1 ADA+ sample |
| GP2017 Adalimumab Continued | ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 | 35.8 % patients with at least 1 ADA+ sample |
Secondary
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time frame: At Week 35 only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | DLQI | 49.0 % of patients with DLQI of 0 or 1 |
| Humira ® Adalimumab | DLQI | 54.5 % of patients with DLQI of 0 or 1 |
| GP2017 Adalimumab Switched | DLQI | 52.9 % of patients with DLQI of 0 or 1 |
| GP2017 Adalimumab Continued | DLQI | 55.9 % of patients with DLQI of 0 or 1 |
Secondary
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time frame: At Week 17 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | DLQI | 50.5 % of patients with DLQI of 0 or 1 |
| Humira ® Adalimumab | DLQI | 48.4 % of patients with DLQI of 0 or 1 |
Secondary
DLQI
Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time frame: At Week 51 only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | DLQI | 48.8 % of patients with DLQI of 0 or 1 |
| Humira ® Adalimumab | DLQI | 55.6 % of patients with DLQI of 0 or 1 |
| GP2017 Adalimumab Switched | DLQI | 54.2 % of patients with DLQI of 0 or 1 |
| GP2017 Adalimumab Continued | DLQI | 59.8 % of patients with DLQI of 0 or 1 |
Secondary
IGA Response Rate
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
Time frame: At Week 35 only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | IGA Response Rate | 59.2 percent of participants |
| Humira ® Adalimumab | IGA Response Rate | 58.2 percent of participants |
| GP2017 Adalimumab Switched | IGA Response Rate | 58.8 percent of participants |
| GP2017 Adalimumab Continued | IGA Response Rate | 58.8 percent of participants |
Secondary
IGA Response Rate
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.
Time frame: At Week 17 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | IGA Response Rate | 53.6 percent of participants |
| Humira ® Adalimumab | IGA Response Rate | 53.6 percent of participants |
Secondary
IGA Response Rate
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
Time frame: At Week 51 only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP2017 Adalimumab | IGA Response Rate | 46.5 percent of participants |
| Humira ® Adalimumab | IGA Response Rate | 55.1 percent of participants |
| GP2017 Adalimumab Switched | IGA Response Rate | 58.3 percent of participants |
| GP2017 Adalimumab Continued | IGA Response Rate | 59.8 percent of participants |
Secondary
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)
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).
Time frame: Baseline to Week 16
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| GP2017 Adalimumab | 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 |
| Humira ® Adalimumab | Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA) | 60.8 percentage change from baseline | Standard Error 1.61 |
95% CI: [-2.78, 5.08]
Secondary
Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)
The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.
Time frame: Baseline to Week 16
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| GP2017 Adalimumab | Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM) | -60.7 percentage change from baseline | Standard Error 1.54 |
| Humira ® Adalimumab | Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM) | -61.5 percentage change from baseline | Standard Error 1.55 |
95% CI: [-3.15, 4.84]
Secondary
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates
Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)
Time frame: At Week 17 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GP2017 Adalimumab | PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | % of patients achieving PASI50 at Week 17 | 93.2 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | % of patients achieving PASI75 at Week 17 | 71.4 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | % of patients achieving PASI90 at Week 17 | 51.6 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | % of patients achieving PASI100 at Week 17 | 21.9 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | % of patients achieving PASI100 at Week 17 | 16.5 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | % of patients achieving PASI50 at Week 17 | 92.8 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | % of patients achieving PASI90 at Week 17 | 44.8 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates | % of patients achieving PASI75 at Week 17 | 68.6 percent of participants |
Secondary
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)
Time frame: At Week 51 only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GP2017 Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI50 at Week 51 | 95.3 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI75 at Week 51 | 76.7 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI90 at Week 51 | 48.8 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI100 at Week 51 | 25.6 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI75 at Week 51 | 79.6 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI90 at Week 51 | 51.0 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI100 at Week 51 | 29.6 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI50 at Week 51 | 93.9 percent of participants |
| GP2017 Adalimumab Switched | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI90 at Week 51 | 60.4 percent of participants |
| GP2017 Adalimumab Switched | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI75 at Week 51 | 75.0 percent of participants |
| GP2017 Adalimumab Switched | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI100 at Week 51 | 31.3 percent of participants |
| GP2017 Adalimumab Switched | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI50 at Week 51 | 87.5 percent of participants |
| GP2017 Adalimumab Continued | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI100 at Week 51 | 35.1 percent of participants |
| GP2017 Adalimumab Continued | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI75 at Week 51 | 84.5 percent of participants |
| GP2017 Adalimumab Continued | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI50 at Week 51 | 95.9 percent of participants |
| GP2017 Adalimumab Continued | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI90 at Week 51 | 62.9 percent of participants |
Secondary
PASI 50, PASI75, PASI 90 and PASI100 Response Rates
Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)
Time frame: At Week 35 only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GP2017 Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI50 at Week 35 | 95.9 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI75 at Week 35 | 73.5 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI90 at Week 35 | 53.1 percent of participants |
| GP2017 Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI100 at Week 35 | 28.6 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI75 at Week 35 | 73.6 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI90 at Week 35 | 52.7 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI100 at Week 35 | 30.9 percent of participants |
| Humira ® Adalimumab | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI50 at Week 35 | 96.4 percent of participants |
| GP2017 Adalimumab Switched | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI90 at Week 35 | 62.7 percent of participants |
| GP2017 Adalimumab Switched | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI75 at Week 35 | 70.6 percent of participants |
| GP2017 Adalimumab Switched | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI100 at Week 35 | 35.3 percent of participants |
| GP2017 Adalimumab Switched | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI50 at Week 35 | 94.1 percent of participants |
| GP2017 Adalimumab Continued | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI100 at Week 35 | 33.3 percent of participants |
| GP2017 Adalimumab Continued | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI75 at Week 35 | 74.5 percent of participants |
| GP2017 Adalimumab Continued | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI50 at Week 35 | 96.1 percent of participants |
| GP2017 Adalimumab Continued | PASI 50, PASI75, PASI 90 and PASI100 Response Rates | % of patients achieving PASI90 at Week 35 | 61.8 percent of participants |