Bimekizumab safety in patients with moderate to severe plaque psoriasis: Pooled data from up to three years of treatment in randomized phase 3 trials

Abstract

Abstract Background Patients with psoriasis require long-term management; therefore, understanding the long-term safety of new treatments, such as bimekizumab, is crucial. Objectives To evaluate bimekizumab’s 3-year safety profile in patients with moderate to severe plaque psoriasis. Methods Three years of safety data were pooled from three phase 3 trials (BE VIVID, BE READY, BE SURE) and their ongoing open-label extension (BE BRIGHT). Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years (PY). Results 1,495 patients received ≥1 bimekizumab dose; total bimekizumab exposure was 3,876.4 PY. The overall EAIR of TEAEs was 175.5/100 PY and decreased with longer exposure to bimekizumab. The most commonly reported TEAEs were nasopharyngitis, oral candidiasis, and upper respiratory tract infection (EAIRs of 15.0/100 PY, 10.1/100 PY, and 6.5/100 PY, respectively); 99.3% of oral candidiasis events were mild or moderate in severity, none were serious, and few led to discontinuation. EAIRs of other TEAEs of interest were low, including serious infections (1.2/100 PY), adjudicated inflammatory bowel disease (0.2/100 PY), and laboratory elevations in aspartate aminotransferase or alanine aminotransferase (>5x upper limit of normal: 0.6/100 PY). Conclusions In these analyses pooled across 3 years, no new safety signals were observed with longer exposure to bimekizumab. The vast majority of oral candidiasis events were mild or moderate in severity, as reported previously. A video summarising this manuscript is available below. Clinicaltrials.gov identifiers NCT03412747, NCT03370133, NCT03410992, NCT03598790