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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.

Original publication




Journal article


Arthritis & rheumatology (hoboken, n.j.)

Publication Date



Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.