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Bimekizumab for patients with moderate-to-severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled phase 2b extension study.

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BACKGROUND Dual neutralization of both interleukin-17A and interleukin-17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin-17A alone. OBJECTIVE To provide longer-term efficacy and… Click to show full abstract

BACKGROUND Dual neutralization of both interleukin-17A and interleukin-17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin-17A alone. OBJECTIVE To provide longer-term efficacy and safety data for bimekizumab from a phase 2b extension study in patients with moderate-to-severe psoriasis (BE ABLE 2, NCT03010527). METHODS After the 12-week initial study (BE ABLE 1), patients who had a Psoriasis Area and Severity Index (PASI) 90 response at week 12 received bimekizumab 64 mg, 160 mg, or 320 mg for an additional 48 weeks (60 weeks in total). The primary objective was safety. RESULTS Across all dose groups (N = 217), initial PASI90 responders generally maintained high levels of efficacy through week 60: PASI90, 80-100%; PASI100, 69-83%; Investigator's Global Assessment 0/1, 78-100% (all non-responder imputation). Incidence of serious treatment-emergent adverse events was 15/217 (6.9%). No cases of inflammatory bowel disease, MACE, or suicidal ideation/behavior were reported. LIMITATIONS Low numbers in the bimekizumab 64 mg group (n = 15). The majority of 60-week data reported here are primarily for the week 12 PASI90 responders only. CONCLUSION Bimekizumab response rates were maintained through week 60. A substantial proportion of patients achieved complete skin clearance. Bimekizumab was generally well tolerated.

Keywords: week; phase extension; extension study; bimekizumab; psoriasis

Journal Title: Journal of the American Academy of Dermatology
Year Published: 2020

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