• The BE SURE study, comparing bimekizumab to Humira® (adalimumab) for the treatment of adults with moderate-to-severe plaque psoriasis, met all co-primary and ranked secondary endpoints • BE SURE is the third Phase 3 bimekizumab psoriasis study to report positive results since October • UCB will submit applications to regulatory authorities for approval of bimekizumab to treat adults with moderate-to-severe plaque psoriasis in mid-2020
Brussels, Belgium – 06 December 2019, 7:00 AM CET – Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced positive results from the Phase 3 active-controlled BE SURE study. BE SURE compared the investigational IL-17A and IL-17F inhibitor bimekizumab to the TNF inhibitor adalimumab in the treatment of adults with moderate-to-severe plaque psoriasis. BE SURE met its co-primary endpoints at week 16, demonstrating superiority of bimekizumab to adalimumab in achieving at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1).
The BE SURE study also met all of its ranked secondary endpoints with statistical significance, including superior total skin clearance at weeks 16 and 24, as measured by PASI 100, compared to adalimumab. Furthermore, bimekizumab was statistically superior to adalimumab in achieving rapid response, defined as PASI 75 at week 4. During the dose-blind maintenance period, high levels of skin clearance were maintained with bimekizumab through week 56. The continued data assessment indicates that the safety profile of bimekizumab was consistent with earlier clinical studies. The full BE SURE results will be presented at a scientific congress in 2020.
BE SURE is the third Phase 3 bimekizumab study to report positive results since October. It follows findings from BE VIVID and BE READY – studies evaluating the efficacy and safety of bimekizumab in adults with moderate-to-severe plaque psoriasis. The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.
“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 Prof. Kristian Reich, M.D., Ph.D., 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, and BE SURE Lead Study Investigator.
“Today’s BE SURE findings are consistent with the positive results we recently announced for both BE VIVID and BE READY. UCB is committed to addressing the critical unmet needs of adult patients with moderate-to-severe plaque psoriasis, particularly complete skin clearance. Our Phase 3 studies have shown that bimekizumab has the potential to make a meaningful difference for these patients,” said Iris Loew-Friedrich, Head of Drug Development and Chief Medical Officer, UCB.
The safety and efficacy of bimekizumab are also being evaluated in psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, with first top-line results expected by the end of 2021.