Positive topline results were announced from a phase 3 study evaluating the efficacy and safety of bimekizumab, an investigational interleukin (IL)-17A and IL-17F inhibitor, in adults with active psoriatic arthritis who were inadequate responders or intolerant to tumor necrosis factor alpha (TNFα) inhibitors.
The multicenter, randomized, double-blind, placebo-controlled BE COMPLETE study (ClinicalTrials.gov Identifier: NCT03896581) included 400 adults with active psoriatic arthritis for at least 6 months prior to screening who also had a history of inadequate response or intolerance to 1 or 2 TNFα inhibitors. Patients were randomly assigned to receive either bimekizumab or placebo subcutaneously.
Findings showed that a statistically significantly greater proportion of patients treated with bimekizumab achieved 50% or greater improvement in the American College of Rheumatology (ACR) 50 response at week 16 compared with those who received placebo (primary endpoint). Bimekizumab also met all ranked secondary endpoints at week 16 vs placebo, including:
- Physical function, as measured by the Health Assessment Questionnaire-Disability Index;
- Skin clearance, as measured by at least 90% improvement in the Psoriasis Area and Severity Index;
- Physical health status, as measured by the Short Form-36-item Health Survey Physical Component Summary score; and
- Low disease activity, as measured by the Minimal Disease Activity index.
The safety profile of bimekizumab was consistent with that observed in previous studies.
“The BE COMPLETE results mark the latest positive data in a series of four phase 3 readouts for bimekizumab in the treatment of psoriatic arthritis and axial spondyloarthritis.” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB. “The positive findings in both studies highlight the clinical potential of bimekizumab in psoriatic arthritis for both biologic naïve and anti-TNF therapy experienced patients.”
The Company plans to submit a Biologics License Application to the Food and Drug Administration (FDA) for the psoriatic arthritis indication in the third quarter of 2022. The Agency is currently reviewing the BLA for bimekizumab for plaque psoriasis, though action on the application was deferred due to COVID-19 related travel restrictions that precluded an on-site facility inspection.
Positive top-line results for bimekizumab in second phase 3 psoriatic arthritis study. News release. UCB, Inc. Accessed January 21, 2022. https://www.prnewswire.com/news-releases/positive-top-line-results-for-bimekizumab-in-second-phase-3-psoriatic-arthritis-study-301465706.html