Bimekizumab FDA Approved for the Treatment of Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved UCB’s BIMZELX (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with active psoriatic arthritis (PsA). This approval marks the first dual IL-17A and IL-17F inhibitor available in the US for PsA, providing a new treatment option for patients with chronic immune-mediated inflammatory disease.

Bimekizumab is administered as a 160 mg injection every 4 weeks and is designed to address both joint and skin symptoms in PsA. The FDA approval is based on results from 2 Phase 3 studies, BE OPTIMAL and BE COMPLETE, which demonstrated statistically significant improvements in joint and skin symptoms compared to placebo at Week 16, with benefits sustained through Week 52. These studies included both biologic-naïve patients and those who had an inadequate response to tumor necrosis factor (TNF) inhibitors, showing bimekizumab’s effectiveness across different patient populations.

In the BE OPTIMAL and BE COMPLETE studies, bimekizumab met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16. In both biologic-naïve patients and those with inadequate responses to tumor necrosis factor (TNF) inhibitors, the clinical responses were significant and maintained through 1 year of treatment.

In addition to joint symptom relief, bimekizumab showed strong results for minimal disease activity (MDA) and complete skin clearance (PASI100). Patients receiving bimekizumab demonstrated considerable improvements in these key secondary endpoints, further highlighting the therapy's potential as a comprehensive treatment for psoriatic arthritis.

Joseph F. Merola, MD, MMSc, emphasized the importance of this approval, noting, "The approval of bimekizumab-bkzx provides a new, differentiated treatment option for patients with active psoriatic arthritis, offering consistent relief in both biologic-naïve patients and those previously unresponsive to TNF inhibitors."

The safety profile of bimekizumab was consistent with known risks of biologic therapies, with most common side effects including upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. No new safety concerns were identified during the clinical trials.

Bimekizumab represents a significant advancement for the treatment of psoriatic arthritis, providing sustained joint and skin symptom relief for patients, particularly those who have not responded to previous treatments. With its dual inhibition of IL-17A and IL-17F, bimekizumab offers a new and promising option for managing this challenging condition.

Reference:

UCB announces U.S. FDA approvals for BIMZELX (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis. Press Release. UCB. September 23, 2024. Accessed September 24, 2024. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-us-fda-approvals-for-bimzelxr-bimekizumab-bkzx-for-the-treatment-of-psoriatic-arthritis-non-radiographic-axial-spondyloarthritis-and-ankylosing-spondylitis