Safety and Efficacy of Bimekizumab in Patients with Active Psoriatic Arthritis: 3-Year Results from a Phase 2b Randomized Controlled Trial and its Open-Label Extension Study.
Coates LC., McInnes IB., Merola JF., Warren RB., Kavanaugh A., Gottlieb AB., Gossec L., Assudani D., Bajracharya R., Coarse J., Ink B., Ritchlin CT.
ObjectiveTo assess long-term safety, tolerability, and efficacy of bimekizumab in active psoriatic arthritis (PsA).MethodsAdult patients with active PsA completing the double- and dose-blind periods of the BE ACTIVE randomized controlled trial could enroll in the open-label extension (OLE) at Week 48, after which patients received bimekizumab 160 mg every four weeks. Safety and efficacy results are presented through 152 weeks.ResultsAt Week 152, 161/206 patients (78.2%) remained in the study. From Weeks 0-152, 184/206 patients (126.4/100 patient-years) had ≥1 treatment-emergent adverse event. Most frequent were nasopharyngitis (7.6), upper respiratory tract infection (6.8), bronchitis (3.5), and oral candidiasis (3.5). 47/206 patients (9.7) had fungal infections; 24/206 (4.6) had Candida infections and 19/206 (3.5) had oral candidiasis. All fungal infections were mild to moderate and localized. Four patients (0.7) had serious infections; there were no reported cases of active tuberculosis, adjudicated major adverse cardiac events, or deaths. Efficacy demonstrated at Week 48 was sustained in the OLE. At Week 152, non-responder imputation (observed case) analysis showed 52.9% (69.4%) of patients achieved American College of Rheumatology criteria 50% response, 57.7% (73.8%) achieved 100% skin clearance per the Psoriasis Area and Severity Index, and 51.5% (67.5%) achieved minimal disease activity. Patients also maintained improvements in pain, physical function, and health-related quality of life.ConclusionsThe safety profile of bimekizumab was consistent with previous reports, with no new safety signals identified. Sustained joint and efficacy responses were observed over three years.