Bimekizumab-bkzx (Bimzelx, UCB) showed sustained control of inflammation and deep efficacy in adults with active psoriatic arthritis (PsA) for up to three years, according to research presented at the European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain.
Results from BE OPTIMAL, BE COMPLETE, and their open-label extension, BE VITAL, showed that bimekizumab delivered sustained efficacy across multiple clinical endpoints for up to three years in patients with active PsA, regardless of prior treatment experience.
Positive Study Results
At three years, 59.5% and 59.1% of biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve and tumor necrosis factor inhibitor inadequate response (TNFi-IR) patients, respectively, achieved elimination of swollen joints. Complete skin clearance, measured by Psoriasis Area and Severity Index [PASI]100, was sustained to three years by 61.9% and 67.5% of bDMARD-naïve and TNFi-IR patients, respectively, the study showed. Minimal disease activity (MDA), a comprehensive and clinically meaningful endpoint, was sustained to three years by 52.9% and 48.8% of bDMARD-naïve and TNFi-IR patients, respectively.
“A primary treatment goal in psoriatic arthritis is sustained control of inflammation to help prevent long-term, irreversible structural damage and to improve quality of life,” says Professor Laure Gossec from the Sorbonne University Hospital, Paris, France in a news release. “These bimekizumab data are notable for their consistency across treatment-naïve and experienced patients, with elimination of swollen joints in nearly sixty percent of patients and approximately half reaching MDA at three years – both strong clinical responses that suggest real control of inflammation in PsA.”
Across the three-year clinical trial data for PsA, bimekizumab was generally well-tolerated and no new safety signals were observed.
About the Phase 3 Trials
BE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of bimekizumab in the treatment of psoriatic arthritis. The primary endpoint in both studies was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at Week 16. BE OPTIMAL (bDMARD-naïve) and BE COMPLETE (TNFi-IR) assessed subcutaneous bimekizumab 160mg every four weeks (Q4W) in patients with PsA; both studies were placebo-controlled to Week 16, after which placebo patients switched to bimekizumab. BE OPTIMAL Week 52 and BE COMPLETE Week 16 completers were eligible for BE VITAL open-label extension.
