Alan Menter1, Petr Arenberger2, Sigrid Balser3, Stefan Beissert4, Ashley Cauthen5, Niklas Czeloth6, Jennifer Soung7, Sasha Jazayeri8, Peter Weisenseel9, Girish Jayadeva6. 1. Baylor Scott & White , Dallas, USA. 2. University Hospital Kralovske Vinohrady , Prague, Czech Republic. 3. Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riss, Germany. 4. Universitätsklinikum Carl Gustav Carus, TU Dresden , Germany. 5. Renstar Medical Research , Ocala, USA. 6. Boehringer Ingelheim International GmbH , Ingelheim am Rhein, Germany. 7. Southern California Dermatology Inc ., Santa Ana, USA. 8. Alliance Dermatology and Mohs Center PC , Phoenix, USA. 9. TFS GmbH , Hamburg, Germany.
Abstract
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: 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.
RCT Entities:
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: 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.
Entities:
Keywords:
(4–6 required): Adalimumab; BI 695501; Biosimilar; Equivalence; Psoriasis
Authors: Jonathan Kay; Vibeke Strand; Alan Menter; Stanley Cohen; Alice Gottlieb; Stephen Hanauer; Sravan Kumar Eduru; Susanne Buschke; Benjamin Lang; Karl-Heinz Liesenfeld; Jennifer Schaible; Dorothy McCabe Journal: Am J Clin Dermatol Date: 2022-08-07 Impact factor: 6.233