UCB presents positive data from Phase 2b psoriasis treatment extension study

UCB presented positive data from the Phase 2b BE ABLE extension study of bimekizumab in patients with moderate-to-severe chronic plaque psoriasis, which showed nearly all BE ABLE 1 responders completing 60 weeks of bimekizumab treatment maintained complete or almost complete skin clearance. The results are the longest-term data so far investigating bimekizumab and further highlight the potential value of the molecule’s unique dual mechanism of action, which potently and selectively neutralizes IL-17F in addition to IL-17A, two key cytokines driving inflammatory processes. Findings were presented at a late breaker session at the American Academy of Dermatology Annual Meeting in Washington, DC. In the BE ABLE 1 study, up to 79% of patients achieved at least 90% skin clearance as soon as week 12, based on a dose range of 64mg, 160mg, 160mg with a 320mg loading dose, 320mg, or 480mg, administered every four weeks. Among these BE ABLE 1 responders, defined as achievement of PASI90 at week 12, 80-100% maintained the rigorous PASI90 measure for up to an additional 48 weeks based on a dose range of 160mg or 320mg, administered every 4 weeks, in the BE ABLE 2 extension study. Further, 70-83% and 78-100% of BE ABLE 1 responders maintained PASI100 and the Investigator’s Global Assessment of response, respectively. The safety profile was consistent with previous studies, with no new safety findings observed. The most frequent treatment-emergent adverse events were oral candidiasis and nasopharyngitis. No cases of suicidal ideation/behavior, major adverse cardiac events, or inflammatory bowel disease were reported. UCB also presented findings this week from the BE AGILE study of bimekizumab in ankylosing spondylitis and the BE ACTIVE study of bimekizumab in psoriatic arthritis. The safety and efficacy of bimekizumab have not been established, and it is not approved by any regulatory authority worldwide.
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