The study included 478 patients with chronic plaque psoriasis for ≥6 months with an affected body surface area of ≥10%, Psoriasis Area and Severity Index (PASI 90) of ≥12 and Investigator Global Assessment (IGA) score ≥3 on a 5-point scale. Patients were randomized to receive bimekizumab or 56 weeks, or adalimumab for the initial 24 weeks followed by bimekizumab until week 56. The co-primary end points were PASI 90 response (defined as a patient that achieved a 90% reduction from baseline in the PASI score) and IGA response (defined as clear or almost clear with at least a 2-category improvement relative to baseline) at week 16.
Results showed that bimekizumab demonstrated superiority to adalimumab, meeting both co-primary end points at week 16. The study also met all of its ranked secondary end points with statistical significance. Patients treated with bimekizumab achieved superior total skin clearance at weeks 16 and 24, as measured by PASI 100, compared with adalimumab. Additionally, bimekizumab demonstrated statistical superiority to adalimumab in achieving rapid response, defined as PASI 75 at week 4. Patients also maintained high levels of skin clearance with bimekizumab through week 56 during the dose-blind maintenance period.
The safety profile of bimekizumab was consistent with that observed in previous clinical studies. Full study results will be presented at a scientific congress in 2020. This study is the third phase 3 bimekizumab study to report positive results, following results from BE VIVID and BE READY in adults with moderate-to-severe plaque psoriasis.
“Active-controlled trials are a key way to inform our clinical understanding and decision making in psoriasis. The results of BE SURE confirmed the superiority of bimekizumab to a widely used TNF inhibitor in psoriasis and further demonstrated the important role of selectively targeting IL-17A and IL-17F,” said lead BE SURE study investigator Prof. Kristian Reich, MD, PhD, Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation Center, Hamburg, Germany.
Bimekizumab, an investigational humanized monoclonal IgG1 antibody, is also being evaluated in psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, with results expected by the end of 2021.
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