EU Approves Bimekizumab for Psoriatic Arthritis and Axial Spondyloarthritis

Lucy Hicks

June 08, 2023

The European Commission has approved bimekizumab (Bimzelx) for the treatment of active psoriatic arthritis (PsA) and active axial spondylarthritis (axSpA) in adults.

The IL-17A and IL-17F inhibitor has already been approved for the treatment of moderate to severe plaque psoriasis in the European Union and in several other countries, including Canada, Great Britain, and Japan. This is the first worldwide authorization of bimekizumab for treating PsA or axSpA, according to an announcement from the biopharmaceutical company UCB.

Bimekizumab is currently pending approval by the US Food and Drug Administration for the treatment of moderate to severe plaque psoriasis.

This newest approval was based on phase 3 trials for patients with PsA and those with axSpA for both nonradiographic and radiographic disease, also called ankylosing spondylitis. In the clinical trials BE COMPLETE and BE OPTIMAL, 43% to 44% of patients with PsA (both biologic-naive patients and those whose condition did not respond to a tumor necrosis factor [TNF] inhibitor) who received bimekizumab 160 mg every 4 weeks achieved 50% improvement in modified American College of Rheumatology response criteria (ACR50) at week 16. From 7% to 10% of the groups that received placebo met the same criteria. These clinical responses were sustained for up to a year.

"The approval of bimekizumab in psoriatic arthritis provides rheumatologists and dermatologists in the European Union with a new treatment option, " said Iain McInnes, MD, PhD, from the Institute of Infection, Immunity, and Inflammation at the University of Glasgow, Glasgow, Scotland, in a UCB press release. He presented data from the BE OPTIMAL trial at the European Alliance of Associations for Rheumatology (EULAR) 2022 Annual Meeting. He noted that the trials demonstrated "consistently high thresholds of disease control " with bimekizumab, compared with placebo.

In BE MOBILE 1, a multicenter trial involving patients with nonradiographic axSpA, 47.7% of patients who received bimekizumab 160 mg every 4 weeks achieved 40% improvement on the Assessment of SpondyloArthritis international Society response criteria (ASAS40) at week 16, compared with 21.4% who received placebo. In BE MOBILE 2, which enrolled patients with ankylosing spondylitis, 44.8% of the bimekizumab group (160 mg every 4 weeks) reached ASAS40 at week 16, compared with 22.5% of the placebo group. The results were consistent across TNF inhibitor-naive and TNF inhibitor-resistant patients. Clinical responses lasted 52 weeks.

This new treatment option for axSpA is "welcome news to the European rheumatology community, " added Désiréé van der Heijde, MD, PhD, of Leiden University Medical Center, Leiden, the Netherlands in a press release, who also presented trial data at EULAR 2022.

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