Bimekizumab Safety in Patients with Moderate to Severe Psoriasis: Analysis of Pooled Data from Phase 2 and 3 Clinical Trials

ConclusionsBimekizumab was well-tolerated across the plaque psoriasis clinical program; most TEAEs were mild to moderate and discontinuations were low.All candida infections were mucocutaneous in origin, with oral candidiasis being most frequent; oral candidiasis TEAEs were predominantly mild to moderate and the vast majority did not lead to discontinuation. ObjectiveTo report short-and longer-term safety data in bimekizumab-treated patients with moderate to severe plaque psoriasis pooled from eight phase 2/3 trials. Background• Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A.1,2 • Given that psoriasis is a chronic disease requiring long-term management, it is important to understand the long-term safety profiles of therapies such as bimekizumab.• We report short-and longer-term safety data in bimekizumab-treated patients with moderate to severe plaque psoriasis, and short-term data from adalimumab, ustekinumab, and placebo phase 3 comparator arms. Methods• Patients were included from four phase 3 trials -BE SURE, BE VIVID, BE READY, and the BE BRIGHT open-label extension (interim cut: November 1, 2019)and four phase 2 studies -BE ABLE 1, BE ABLE 2, PS0016, and PS0018.Patients received bimekizumab 320 mg every 4 or 8 weeks (Q4W/Q8W; additional doses used in phase 2), adalimumab, ustekinumab, or placebo.• Short-term safety from the initial treatment periods (Weeks 0-16) of three of the phase 3 trials (BE SURE, BE VIVID, and BE READY) was evaluated for patients who received ≥1 dose of bimekizumab, adalimumab, ustekinumab, or placebo.• Longer-term safety was also evaluated for patients who received ≥1 dose of bimekizumab in BE SURE, BE VIVID, BE READY, BE BRIGHT, and the four phase 2 trials.• We report treatment emergent adverse events (TEAEs; n [%]) for the initial treatment period for patients receiving bimekizumab 320 mg Q4W, adalimumab, ustekinumab, and placebo, as well as longer-term TEAEs for patients receiving bimekizumab 320 mg Q4W and all other doses of bimekizumab.-Exposure-adjusted incidence rates (EAIRs) are the incidence of new cases per 100 patient-years (PY) in patients receiving bimekizumab 320 mg Q4W (short-term) and all patients receiving any dose of bimekizumab (longer-term).-TEAEs were coded using MedDRA v19.0. Results Patient Population• Over 16 weeks, 989 patients with psoriasis received ≥1 bimekizumab dose, 159 patients received adalimumab, 163 patients received ustekinumab, and 169 patients received placebo.• Patient demographics and baseline disease characteristics are reported in Table 1. Short-Term Safety Outcomes• 593 (60.0%) bimekizumab-treated patients experienced ≥1 TEAE, versus 96 (60.4%) adalimumab-treated patients, 83 (50.9%) ustekinumab-treated patients, and 74 (43.8%) placebo-treated patients (Table 2).• Serious TEAEs occurred in <4% of patients in each treatment group, ranging from 1.5% for bimekizumab to 3.1% for ustekinumab.• Discontinuations due to TEAEs occurred in <5% of patients in each group, ranging from 1.7% for bimekizumab to 4.1% for placebo (Table 2).

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