Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study.

Abstract

OBJECTIVES:

Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy versus placebo (PBO) at Week 16 in biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with active psoriatic arthritis (PsA). Here, we report long-term efficacy and safety to Week 52.

METHODS:

BE OPTIMAL comprised a 16-week, double-blind, PBO-controlled period, then 36 weeks treatment-blind. Patients were randomised 3:2:1 to subcutaneous BKZ 160 mg every 4 weeks, PBO with switch to BKZ at Week 16, or reference arm (adalimumab (ADA) 40 mg every 2 weeks). Efficacy outcomes included the American College of Rheumatology (ACR) response criteria 20/50/70, Psoriasis Area and Severity Index (PASI) 75/90/100 in patients with baseline psoriasis affecting ≥3% body surface area and minimal disease activity (MDA); non-responder imputation.

RESULTS:

ACR20/50/70, PASI75/90/100 and MDA responses were sustained with BKZ to Week 52, consistent with results observed at Week 16. Patients who switched to BKZ at Week 16 demonstrated improvements in efficacy with similar results to BKZ-randomised patients by Week 52.To Week 52, 555/702 (79.1%) patients had ≥1 treatment-emergent adverse event (TEAE) during BKZ treatment; 113/140 (80.7%) on ADA. On BKZ, 46 (6.6%) patients had serious TEAEs. 54 (7.7%) Candida infections occurred during BKZ treatment and 1 (0.7%) during ADA; all cases were localised and non-serious. One death occurred in a BKZ-treated patient, unrelated to treatment.

CONCLUSIONS:

The efficacy of BKZ in bDMARD-naïve patients with PsA was sustained from Week 16 to Week 52. BKZ was well tolerated with no new safety signals observed.

TRIAL REGISTRATION NUMBER:

NCT03895203.

• Authors: Christopher T Ritchlin, Laura C Coates, Iain B McInnes, Philip J Mease, Joseph F Merola, Yoshiya Tanaka, Akihiko Asahina, Laure Gossec, Alice B Gottlieb, Richard B Warren, Barbara Ink, Rajan Bajracharya, Vishvesh Shende, Jason Coarse, Robert Bm Landewé
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 82 Issue 11 Pg. 1404-1414 (11 2023) ISSN: 1468-2060 [Electronic] England
• PMID: 37696588 (Publication Type: Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• bimekizumab
• Antirheumatic Agents
• Adalimumab
• Antibodies, Monoclonal
• Biological Products

Topics

• Humans
• Arthritis, Psoriatic (drug therapy)
• Treatment Outcome
• Antirheumatic Agents (adverse effects)
• Adalimumab (therapeutic use)
• Antibodies, Monoclonal (therapeutic use)
• Psoriasis (drug therapy)
• Biological Products (therapeutic use)
• Double-Blind Method
• Severity of Illness Index