Phase 3
Completed N=465
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
Plaque Type Psoriasis
Source: ClinicalTrials.gov NCT02016105 ↗
Enrolled (actual)
465
Serious AEs
5.8%
Results posted
Apr 2017
Primary outcomePrimary: PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab — 66.8; 65.0 percent of participants
◆ Published Evidence
Established
21citations · ~4 / year
Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS).
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.
Linked Publications (3)
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Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS).
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Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies.
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Comparison of treatment with GP2017 (an adalimumab biosimilar) and reference adalimumab in people with plaque psoriasis: a plain language summary of the ADACCESS trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab |
66.8; 65.0 | — |
| SECONDARY Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM) |
-60.7; -61.5 | — |
| SECONDARY Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA) |
-59.7; 60.8 | — |
| SECONDARY PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates |
93.2; 92.8; 71.4; 68.6; 51.6; 44.8 | — |
| SECONDARY PASI 50, PASI75, PASI 90 and PASI100 Response Rates |
95.3; 93.9; 87.5; 95.9; 76.7; 79.6 | — |
| SECONDARY IGA Response Rate |
46.5; 55.1; 58.3; 59.8 | — |
| SECONDARY DLQI |
48.8; 55.6; 54.2; 59.8 | — |
| SECONDARY ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17 |
36.8; 34.1 | — |
| SECONDARY ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51 |
39.3; 45.1; 46.7; 35.8 | — |
Eligibility Criteria
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-/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02016105) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.