UCB achieved positive results from the Phase III active-controlled BE SURE study comparing the investigational IL-17A and IL-17F inhibitor bimekizumab to the TNF inhibitor adalimumab (Abbvie’s Humira) in the treatment of moderate-to-severe plaque psoriasis. The trial 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 secondary endpoints with statistical significance, including superior total skin clearance at weeks 16 and 24, as measured by PASI 100, compared to adalimumab. Bimekizumab was also 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.

BE SURE is the third Phase III bimekizumab study to report positive results since October. It follows findings from BE VIVID3 and BE READY2 – studies evaluating the efficacy and safety of bimekizumab in adults with moderate-to-severe plaque psoriasis.

“These 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 III 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.