“The European Commission’s parallel approval of bimekizumab in PsA and axSpA builds on the momentum created since its first approval in moderate to severe plaque psoriasis and marks an exciting milestone offering healthcare professionals and patients the first IL-17A and IL-17F inhibitorIL-17F inhibitor for treatment of these diseases,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “The extended approval for bimekizumab in the European Union reflects our commitment to address unmet patient needs, improve patient outcomes and raise standards of care.” In PsA, bimekizumab is approved alone or in combination with methotrexate for the treatment of adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).1 In axSpA, bimekizumab is approved for the treatment of adults with active nr-axSpA with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs, and for the treatment of adults with active AS who have responded inadequately or are intolerant to conventional therapy.1 Bimekizumab in PsA: Highlights from BE OPTIMAL and BE COMPLETE The EC approval in PsA is based on results from the Phase 3 BE OPTIMAL and BE COMPLETE studies.1,2,3 In the two studies, bimekizumab met the primary endpoint of ACR50 response at Week 16 vs. placebo, and all ranked secondary endpoints.1,2,3 Consistent results were seen across both biologic-naïve and TNF-inhibitorTNF-inhibitor inadequate responder (TNFi-IR) populations.1 2,3 Clinical responses achieved at Week 16 were sustained up to Week 52 in BE OPTIMAL as assessed by ACR50, PASI90, PASI100 and Minimal Disease Activity (MDA).1 Bimekizumab in axSpA: Highlights from BE MOBILE 1 and BE MOBILE 2 The EC approval in axSpA is based on results from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies.1,4 In the two studies, bimekizumab met the primary endpoint of Assessment of SpondyloArthritis international Society (ASAS) 40 response at Week 16 vs. placebo, and all ranked secondary endpoints.4 ASAS40 responses were consistent across TNFi-naïve and TNFi-inadequate responder patients.4 Clinical responses achieved at Week 16 were sustained in both nr-axSpA and AS patient populations up to Week 52 as assessed by ASAS40 and other endpoints.1,5 In addition, in pooled data from BE MOBILE 1 and BE MOBILE 2, at Week 16, the proportion of patients developing a uveitis event was lower with bimekizumab (0.6 per cent) compared to placebo (4.6 percent). The incidence of uveitis remained low with long-term treatment with bimekizumab (1.2/100 patient-years in the pooled Phase 2/3 studies).1 “Today’s approval of a new treatment option for axial spondyloarthritis is welcome news to the European rheumatology community. In phase 3 clinical studies a greater proportion of patients treated with bimekizumab, compared with placebo, achieved high treatment targets with significant improvement in signs, symptoms and measures of disease activity across the full spectrum of disease, including non-radiographic and radiographic populations,” said Professor Désirée van der Heijde, Professor of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands. About BE OPTIMAL and BE COMPLETE
About BE MOBILE 1 and BE MOBILE 2
The efficacy and safety of bimekizumab (160 mg every four weeks) were evaluated in 586 adult patients with active axial spondyloarthritis (axSpA) in two multicenter, randomized, double-blind, placebo-controlled studies, one in non-radiographic axSpA (nr-axSpA; BE MOBILE 1) and one in ankylosing spondylitis (AS; BE MOBILE 2), also known as radiographic axSpA.1,4 The BE MOBILE 1 and BE MOBILE 2 studies evaluated 254 and 332 patients, respectively.4 Detailed findings from the BE MOBILE 1 and BE MOBILE 2 studies are published in the Annals of the Rheumatic Diseases.4 Live vaccines should not be given in patients treated with bimekizumab. Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information.
European SmPC date of revision: June 2023.
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product- information_en.pdf
*EU/EEA means European Union/European Economic Area
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
For further information, contact UCB: UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.