Abstract
Abstract
Objectives
To evaluate the long-term efficacy of bimekizumab in patients with psoriatic arthritis (PsA) across the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) domains, PsA-related conditions, and comorbidities.
Methods
Post hoc analysis of pooled data from BE OPTIMAL (NCT03895203; biologic-naïve patients) and BE COMPLETE (NCT03896581; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors) phase 3 studies, and their open-label extension BE VITAL (NCT04009499), which assessed subcutaneous bimekizumab 160 mg every 4 weeks in patients with active PsA. Efficacy was assessed to 3 years (Week 148) across GRAPPA core domains, PsA-related conditions (inflammatory bowel disease [IBD] and uveitis), and inflammatory markers of cardiovascular risk.
Results
Among 1,112 bimekizumab-treated patients with PsA, improvements were sustained across the GRAPPA core domains to 3 years. Resolution of swollen and tender joint count at 3 years was achieved by 59.2% and 34.6% of patients, respectively, while 54.8% achieved ≥50% improvement from baseline in American College of Rheumatology response criteria (modified non-responder imputation [mNRI]). Enthesitis (LEI=0) and dactylitis (LDI=0) resolution was also achieved by 56.6% (mNRI) and 68.6% (NRI) of patients, respectively. A high proportion of patients achieved skin and nail psoriasis clearance (PASI100: 64.6%; mNAPSI=0: 68.0%; mNRI). IBD and uveitis events were rare, and inflammatory cardiovascular risk marker improvements were sustained.
Conclusion
Bimekizumab provided long-term, sustained disease control across GRAPPA domains and systemic inflammation markers in patients with PsA, with low rates of IBD and uveitis, supporting its use as a long-term treatment for the heterogeneous manifestations of PsA.
Clinical trial registration
BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499