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
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
- Klíčová slova
- Adalimumab, BI 695501, biosimilar, equivalence, psoriasis,
- MeSH
- adalimumab škodlivé účinky MeSH
- biosimilární léčivé přípravky * škodlivé účinky MeSH
- dvojitá slepá metoda MeSH
- lidé MeSH
- psoriáza * farmakoterapie MeSH
- stupeň závažnosti nemoci MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- adalimumab MeSH
- BI 695501 MeSH Prohlížeč
- biosimilární léčivé přípravky * 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
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT02850965
