Positive topline results were announced from the phase 3 BE OPTIMAL study evaluating the efficacy and safety of bimekizumab for the treatment of active psoriatic arthritis in adults who are biologic disease-modifying antirheumatic drug naïve.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F. The randomized, double-blind, placebo-controlled, noninferential active reference arm, parallel group BE OPTIMAL study (ClinicalTrials.gov Identifier: NCT03895203) included 852 patients with active psoriatic arthritis of at least 6 months duration prior to screening, a baseline tender joint count of at least 3 out of 68, and swollen joint count of at least 3 out of 66.
Patients were randomly assigned to receive bimekizumab, placebo, or adalimumab at prespecified time intervals. The primary endpoint was the proportion of patients who achieved an American College of Rheumatology (ACR) 50 response at week 16, defined as having 50% or greater improvement of arthritis from baseline.
Interim results demonstrated that a significantly greater proportion of patients treated with bimekizumab achieved an ACR50 response at week 16 compared with placebo. Bimekizumab also met all ranked secondary endpoints including significant improvements for physical function, as measured by the Health Assessment Questionnaire-Disability Index; skin clearance, as measured by at least a 90% improvement in the Psoriasis Area and Severity Index; and joint radiographic progression, as measured by the van der Heijde modified Total Sharp Score.
The safety profile of bimekizumab was consistent with that observed in previous studies. There were no new safety signals reported. Full detailed results will be presented at an upcoming medical conference and published in a peer-reviewed medical journal.
“The clinically meaningful improvements seen in both joint and skin symptoms strengthen our belief that bimekizumab can address the unmet needs of patients with psoriatic arthritis,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.
The Food and Drug Administration (FDA) is currently reviewing the Biologics License Application for bimekizumab for the treatment of moderate to severe plaque psoriasis.
Positive top-line results from bimekizumab phase 3 psoriatic arthritis study demonstrated significant improvements in joint and skin symptoms. News release. UCB. Accessed November 19, 2021. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/positive-top-line-results-bimekizumab-phase-3-psoriatic-arthritis-study-demonstrated-significant-improvements-in-joint-and-skin-symptoms.