Health Boards
UCB publish "Be Radiant" and "Be Sure" phase 3 data.
Source: ucb.com
Quote:
BE RADIANT RESULTS
The Phase 3b BE RADIANT study compared the efficacy and safety of bimekizumab to secukinumab in adults with moderate to severe plaque psoriasis. The study met its primary endpoint, with significantly more patients treated with bimekizumab achieving complete skin clearance, as measured by a 100 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 100) at week 16, compared to those treated with secukinumab (61.7 percent versus 48.9 percent, respectively; p<0.001).
The study also met all ranked secondary endpoints.1 The superior levels of complete skin clearance observed at week 16 continued through to week 48, with 67.0 percent of patients treated with bimekizumab, achieving PASI 100, compared to 46.2 percent of patients treated with secukinumab (p<0.001). At week 48, both bimekizumab maintenance dosing groups (every four weeks [Q4W] and every eight weeks [Q8W]), showed higher rates of complete skin clearance (PASI 100), compared with secukinumab (p<0.001). In addition, at week 4, significantly more patients treated with bimekizumab achieved PASI 75 compared to patients treated with secukinumab (71.0 percent versus 47.3 percent, respectively; p<0.001).
“In BE RADIANT, patients treated with bimekizumab achieved superior levels of complete skin clearance, PASI 100, compared with secukinumab-treated patients at week 16, the primary endpoint of the study, and up to 48 weeks of therapy. At week 4, a faster onset of response was also observed with bimekizumab compared with secukinumab. Data from this study support the value of inhibition of IL-17F in addition to IL-17A in the treatment of patients with moderate to severe plaque psoriasis.” said Prof. Kristian Reich, M.D., Ph.D., Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany.
Across the study duration, the most common treatment-emergent adverse events (TEAEs) with bimekizumab were upper respiratory tract infections* (38.9 percent), oral candidiasis (19.3 percent) and urinary tract infection (6.7 percent). Oral candidiasis cases were predominantly mild or moderate and none led to discontinuation. Over 48 weeks, the incidence of serious TEAEs was 5.9 percent with bimekizumab and 5.7 percent with secukinumab.
BE SURE RESULTS
The Phase 3 BE SURE study compared the efficacy and safety of bimekizumab to adalimumab in adults with moderate to severe plaque psoriasis. Results from the BE SURE study were previously reported at the European Academy of Dermatology and Venereology (EADV) Congress 2020.
BE SURE met its co-primary endpoints, demonstrating that bimekizumab-treated patients achieved superior levels of skin clearance, at week 16, compared to those who received adalimumab, as measured by PASI 90 and Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1); p<0.001 for both comparisons. These results were further supported by the study meeting all ranked secondary endpoints. The safety profile of bimekizumab was consistent with earlier clinical studies with no new safety signals identified.
In September 2020, UCB announced that the FDA and EMA had accepted the Company’s Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults. UCB is committed to bringing bimekizumab to patients worldwide and additional regulatory filings are underway.
About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17F has overlapping biology with IL-17A and drives inflammation independently of IL-17A.Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone. The safety and efficacy of bimekizumab are being evaluated across multiple disease states as part of a robust clinical program.
Source: ucb.com
