Bimekizumab safety and tolerability in patients with moderate to severe hidradenitis suppurativa: 2-year results from BE HEARD EXT

Introduction: Hidradenitis suppurativa (HS) is a chronic, systemic, inflammatory skin disease characterized by painful lesions.[1] 1- and 2-year safety data for bimekizumab (BKZ), a humanized monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients with moderate to severe HS are reported.
Methods: Patients who completed the 48-week BE HEARD I&II (BHI&II) trials could enroll in the open-label extension, BE HEARD EXT (BHEXT), and receive open-label BKZ every 2 weeks (Q2W) or BKZQ4W.[2,3] Treatment-emergent adverse events (TEAEs) are reported as exposure-adjusted incidence rates (EAIRs; per 100 patient-years [PY]) in patients who received ≥1 BKZ dose (BKZ Total) across pooled BHI&II/BHEXT at 1 and 2 years (data cut-off November 2023).
Results: Among 1,014 patients enrolled in BHI&II, 995 BKZ-treated patients, pooled across BHI&II/BHEXT, were included in this analysis (Year1: N=995; Year2: N=754). Over 2 years, ≥1 TEAE occurred at an EAIR of 261.3/100 PY (Year1: 285.3/100PY; Year2: 266.7/100PY), severe TEAEs occurred at 8.3/100PY (Year1: 10.2/100PY; Year2: 7.3/100PY), and serious TEAEs occurred at 7.3/100PY (Year1: 7.9/100PY; Year2: 7.9/100PY). The most common TEAEs over 2 years were hidradenitis (events related to HS; abscesses/pain/worsening) at 23.0/100PY (Year1: 25.2/100PY; Year2: 27.1/100PY), coronavirus infection at 17.3/100PY (Year1: 14.6/100PY; Year2: 21.3/100PY), and oral candidiasis at 12.0/100PY (Year1: 15.4/100Y; Year2: 12.1/100PY). TEAEs leading to death were reported in 2 patients over 2 years (1 cardiac failure congestive, 1 central nervous system infection).
Conclusions: BKZ was well tolerated in patients with moderate to severe HS over 2 years, with no new safety signals observed in Year2.