FDA Approves Bimekizumab-Bkzx for Psoriatic Arthritis, 2 Other Indications
The monoclonal antibody was also approved for active non-radiographic axial spondyloarthritis and active ankylosing spondylitis.
The FDA approved bimekizumab-bkzx (Bimzelx) for the treatment of active psoriatic arthritis in adults, active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation in adults, and active ankylosing spondylitis (AS) in adults, pharmaceutical company UCB announced in a release.1 The 3 new indications follow the October 2023 approval of the therapy to treat plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
FDA Approves Bimekizumab-Bkzx for Psoriatic Arthritis, 2 Other Indications / Tada Images - stock.adobe.com
The approval of bimekizumab-bkzx for active psoriatic arthritis was based on results from the BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) trials. Data from both studies were published separately in The Lancet.2,3 The approval for nr-axSpA was based on data from the BE MOBILE 1 (NCT03928704) study and the approval for AS was based on data from the BE MOBILE 2 (NCT03928743) study. Data from both studies were published in the Annals of Rheumatic Diseases.4
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“The approval of Bimzelx in the US across three new indications—active psoriatic arthritis, active non-radiographic axSpA with objective signs of inflammation, and active ankylosing spondylitis—highlights the clinical benefit of dual inhibition of both IL-17A and IL-17F for patients, and provides an opportunity for more people living with chronic inflammatory diseases to achieve meaningful outcomes,” Emmanuel Caeymaex, executive vice president, head of patient impact, and chief commercial officer at UCB, said in a release.1
BE OPTIMAL was a multicenter, randomized, double-blind, placebo-controlled, active reference phase 3 study. BE COMPLETE was a multicenter, randomized, double-blind, placebo-controlled phase 3 study. The studies evaluated the efficacy and safety of bimekizumab-bkzx in adults with active psoriatic arthritis. BE OPTIMAL included 852 patients, of which 431 received bimekizumab-bkzx, 281 received placebo, and 140 received adalimumab. BE COMPLETE included 400 patients, of which 267 received bimekizumab-bkzx and 133 received placebo.
In both trials, bimekizumab-bkzx met its primary endpoint of American College of Rheumatology 50 (ACR50) response at week 16. The therapy also met key secondary endpoints, including Psoriasis Area and Severity Index 90 (PASI90), minimal disease activity, and PASI100. The results were seen to be consistent across biologic-naïve and TNF inhibitor inadequate responder (TNFi-IR) populations. In an open-label extension study, clinical responses achieved at Week 16 were sustained to week 52.
“In Phase 3 clinical studies, the clinically meaningful and consistent clinical response in patients who had a previous inadequate response to TNF inhibitors, and in patients who were new to biologics, suggest that bimekizumab-bkzx has the potential to be an important new treatment option in our armamentarium for adults with psoriatic arthritis,” Joseph F. Merola, MD, MMSc, professor, dermatologist, and rheumatologist, said in a release.1 “The approval of bimekizumab-bkzx for the treatment of active psoriatic arthritis provides a new, differentiated treatment option for the rheumatology and dermatology communities.”
BE MOBILE 1 and BE MOBILE 2 were multicenter, randomized, double-blind, placebo-controlled phase 3 studies evaluating the efficacy and safety of bimekizumab-bkzx in adults with nr-axSpA and AS, respectively. BE MOBILE 1 included 274 patients and BE MOBILE 2 included 332 patients. The primary endpoint for both studies was Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at week 16. Secondary endpoints included ASAS40 response in TNFα inhibitor-naïve subjects at week 16 and ASAS20 response at week 16.
In both studies, patients who received bimekizumab-bkzx achieved ASAS40 response at week 16, which was sustained to week 52. Patients who switched from placebo to bimekizumab-bkzx at Week 16 had comparable responses to patients who initially received bimekizumab-bkzx at week 52. Additionally, the safety profile of the therapy was consistent with the known safety of bimekizumab-bkzx.
“People living with non-radiographic axial spondyloarthritis and ankylosing spondylitis experience pain, stiffness and fatigue that can limit their daily activities, ability to work, and quality of life,” Seth Ginsberg, co-founder and president of the Global Health Living Foundation and CreakyJoints, said in a release.1 “A new treatment option offers the opportunity for more patients to reach their treatment goals.”
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