UCB announced new long-term data from the BIMZELX® (bimekizumab) Phase 2b study BE AGILE and its open-label extension (OLE). Patients with ankylosing spondylitis (AS) treated with BIMZELX, an IL-17A and IL-17F inhibitor, showed sustained improvements in signs and symptoms, disease activity, physical function, and health-related quality of life for up to five years, with a consistent safety profile through five years of treatment.1 These data are being presented this week at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, November 10?15. BIMZELX is not approved in the U.S. for the treatment of AS.

In the U.S., the efficacy and safety of BIMZELX for the treatment of AS have not been established. In the U.S., BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Of 255/303 (84.2 percent) patients who entered the OLE at Week 48, and received =1 BIMZELX dose, 202/255 (79.2 percent) completed to Week 256.

Clinical improvements were sustained across the endpoints detailed below through Week 256 in patients receiving BIMZELX. ASAS40: At the OLE entry visit (Week 48), 51.7% of patients who started the dose-blind period (n=296) achieved ASAS40, a 40 percent improvement response according to Assessment of Spondyloarthritis international Society (ASAS) criteria and 49.7 percent of patients achieved ASAS40 at five years (Week 256; non-responder imputation).1 Of patients who entered the OLE at Week 48 (n=249), 59.8 percent achieved ASAS40 at Week 48 and 59.0 percent at five years (Week 256; non-responder imputation). Disease Activity: Mean reduction from baseline to Week 48 in Ankylosing Spondylitis Disease Activity Score (ASDAS, 3.9 to 2.1, respectively) in patients who entered the dose-blind period were sustained at five years (2.1, multiple imputation).

At Week 48, 49.3 percent who started the dose-blind period (n=296) achieved low disease activity (LDA) status, as measured by ASDAS<2.1 and 41.6 percent of patients had ASDAS LDA at five years (Week 256; non-responder imputation).1 Of patients who entered the OLE at Week 48 (n=249), 57.3 percent achieved ASDAS LDA at Week 48 with 66.0 percent at five years (Week 256; multiple imputation). Mean reductions from baseline to Week 48 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, 6.5 to 3.0, respectively) in patients who entered the dose-blind period were sustained or further decreased to 2.5 at five years (Week 256; multiple imputation).1 Responses for patients who entered the OLE were similar. Physical Function and Quality of Life: Improvements in physical function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) and mean improvements in quality of life measured by the Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) were sustained to Week 256.

Over five years, exposure adjusted incidence rates (EAIRs) per 100 patient years were 134.6 for any treatment emergent adverse event (TEAE) and 5.2 for serious TEAEs. The EAIR of Candida infections over 256 weeks at 2.6 was lower than in weeks 0?48 (7.5). All Candida infections were mild or moderate, and none were systemic.