FDA Grants Approval for Bimekizumab-Bkzx for Psoriatic Arthritis and Two Additional Conditions

The FDA has approved bimekizumab-bkzx (Bimzelx) for treating 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, as announced by pharmaceutical company UCB. This approval follows the October 2023 authorization of the drug for managing plaque psoriasis in adults who are suitable candidates for systemic therapy or phototherapy.

The decision to approve bimekizumab-bkzx for active psoriatic arthritis was based on findings from the BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) trials, with results from both studies published in The Lancet. The approval for nr-axSpA stemmed from the BE MOBILE 1 (NCT03928704) study, while the AS approval was supported by data from the BE MOBILE 2 (NCT03928743) study, both of which were published in the Annals of Rheumatic Diseases.

“The approval of Bimzelx in the U.S. for three new indications—active psoriatic arthritis, active non-radiographic axSpA with objective inflammation signs, and active ankylosing spondylitis—demonstrates the clinical advantages of dual inhibition of IL-17A and IL-17F for patients, offering more individuals with chronic inflammatory diseases a chance to achieve significant improvements,” stated Emmanuel Caeymaex, UCB’s executive vice president and chief commercial officer.

BE OPTIMAL was a multicenter, randomized, double-blind, placebo-controlled, active reference phase 3 study, while BE COMPLETE was also a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. Both studies assessed the efficacy and safety of bimekizumab-bkzx in adults with active psoriatic arthritis. BE OPTIMAL involved 852 patients, with 431 receiving bimekizumab-bkzx, 281 receiving a placebo, and 140 receiving adalimumab. BE COMPLETE included 400 patients, with 267 receiving bimekizumab-bkzx and 133 receiving placebo.

In both trials, bimekizumab-bkzx achieved its primary endpoint of American College of Rheumatology 50 (ACR50) response at week 16. The therapy also met important secondary endpoints, such as Psoriasis Area and Severity Index 90 (PASI90), minimal disease activity, and PASI100. Consistent results were observed in both biologic-naïve and TNF inhibitor inadequate responder (TNFi-IR) groups. Additionally, clinical responses noted at week 16 were maintained through week 52 in an open-label extension study.

“Phase 3 clinical trials show a meaningful and consistent clinical response in patients who previously had inadequate responses to TNF inhibitors, as well as in those who were new to biologics, indicating that bimekizumab-bkzx could be a significant new treatment option for adults with psoriatic arthritis,” commented Joseph F. Merola, MD, MMSc, a professor and dermatologist. “The approval of bimekizumab-bkzx for active psoriatic arthritis provides a new, distinctive treatment option for both rheumatology and dermatology practitioners.”

The BE MOBILE 1 and BE MOBILE 2 studies were multicenter, randomized, double-blind, placebo-controlled phase 3 trials that investigated the efficacy and safety of bimekizumab-bkzx in adults with nr-axSpA and AS, respectively. BE MOBILE 1 involved 274 patients, while BE MOBILE 2 included 332 patients. The primary endpoint for both studies was the Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) at week 16, with secondary endpoints including ASAS40 responses in TNFα inhibitor-naïve subjects and ASAS20 responses.

In both studies, patients treated with bimekizumab-bkzx achieved ASAS40 responses by week 16, which were sustained until week 52. Those who switched from placebo to bimekizumab-bkzx at week 16 showed comparable responses to those who had initially received the treatment by week 52. The safety profile of the drug was consistent with previous findings.

“Individuals suffering from non-radiographic axial spondyloarthritis and ankylosing spondylitis often face pain, stiffness, and fatigue that can hinder their daily activities and overall quality of life,” remarked Seth Ginsberg, co-founder and president of the Global Health Living Foundation and CreakyJoints. “The introduction of a new treatment option can help more patients achieve their treatment goals.”

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