Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study
Language English Country Great Britain, England Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- Keywords
- Adalimumab, BI 695501, biosimilar, equivalence, psoriasis,
- MeSH
- Adalimumab adverse effects MeSH
- Biosimilar Pharmaceuticals * adverse effects MeSH
- Double-Blind Method MeSH
- Humans MeSH
- Psoriasis * drug therapy MeSH
- Severity of Illness Index MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Adalimumab MeSH
- BI 695501 MeSH Browser
- Biosimilar Pharmaceuticals * MeSH
Background: BI 695501 is an approved biosimilar to Humira® reference product (RP). Research design and methods: In this randomized Phase III trial (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy endpoint: the proportion of patients with ≥75% reduction in Psoriasis Area and Severity Index (PASI 75) response at week 16 (±18% equivalence limits for two-sided 95% confidence interval between treatment groups). Safety, pharmacokinetics, and immunogenicity were also assessed. Results: Baseline characteristics were balanced between treated groups (BI 695501, n = 159; adalimumab RP, n = 158). PASI 75 response rates (full analysis set, n = 158; n = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI: -14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab RP) were anti-drug antibody-positive. Conclusion: These data demonstrate equivalent efficacy and highly similar safety and immunogenicity between BI 695501 and adalimumab RP in patients with chronic plaque psoriasis. Study identifier: NCT02850965.
Alliance Dermatology and Mohs Center PC Phoenix AZ USA
Boehringer Ingelheim International GmbH Ingelheim am Rhein Germany
Boehringer Ingelheim Pharma GmbH and Co KG Biberach an der Riss Germany
Department of Dermatology Universitätsklinikum Carl Gustav Carus TU Dresden Dresden Germany
Institute for Rehabilitation Baylor Scott and White Dallas TX USA
Renstar Medical Research Ocala FL USA
References provided by Crossref.org
ClinicalTrials.gov
NCT02850965
