Journal of the American Academy of Dermatology · 2025
Bimekizumab demonstrated a favorable safety profile and high levels of efficacy with up to 2 years of treatment in patients with moderate to severe hidradenitis suppurativa: Pooled results from two phase 3 randomized, controlled trials and their open-label extension.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Sayed Christopher J, Kirby Brian, Garg Amit, Naik Haley B, Kimball Alexa B, Zouboulis Christos C, Jemec Gregor B E, Kokolakis Georgios, Ingram John R, Morita Akimichi, Deherder Delphine, Crater Christina, Rolleri Robert L, Vaux Tom, Lambert Jérémy, Lukowski Bartosz, Bechara Falk G
Аннотация
BACKGROUND: Hidradenitis suppurativa is a chronic inflammatory disease, requiring treatment with durable efficacy and tolerability.
OBJECTIVE: To report the safety and efficacy of bimekizumab up to 2 years.
METHODS: Data from the BE HEARD I&II phase 3 trials and their open-label extension, BE HEARD Extension, were pooled to assess the safety and efficacy of bimekizumab in patients with moderate to severe hidradenitis suppurativa up to 2 years. For safety, exposure-adjusted incidence rates of treatment-emergent adverse events per 100 patient-years (TEAEs/100 PY) were evaluated. For efficacy, lesional-/skin pain-/health-related quality of life (HRQoL) outcomes were assessed.
RESULTS: Five hundred fifty-six patients entered the open-label extension; 446 received bimekizumab to Year 2. TEAEs did not increase with longer bimekizumab exposure (Year 1: 261.6/100 PY; Year 2: 235.7/100 PY). In Year 2, the most common TEAEs were hidradenitis (26.6/100 PY), coronavirus infection (23.1/100 PY), and oral candidiasis (12.5/100 PY). Most patients achieved HiSCR50/75/90/100 at Year 2 (85.4%/77.1%/57.6%/44.2%). Improvements in skin pain and HRQoL achieved at Year 1 were sustained at Year 2.
LIMITATIONS: Patient inclusion criteria limit real-world generalizability.
CONCLUSIONS: Bimekizumab was well-tolerated up to 2 years; no new safety signals were identified with longer exposure. Bimekizumab provided deep, durable improvements in clinical and HRQoL outcomes.
OBJECTIVE: To report the safety and efficacy of bimekizumab up to 2 years.
METHODS: Data from the BE HEARD I&II phase 3 trials and their open-label extension, BE HEARD Extension, were pooled to assess the safety and efficacy of bimekizumab in patients with moderate to severe hidradenitis suppurativa up to 2 years. For safety, exposure-adjusted incidence rates of treatment-emergent adverse events per 100 patient-years (TEAEs/100 PY) were evaluated. For efficacy, lesional-/skin pain-/health-related quality of life (HRQoL) outcomes were assessed.
RESULTS: Five hundred fifty-six patients entered the open-label extension; 446 received bimekizumab to Year 2. TEAEs did not increase with longer bimekizumab exposure (Year 1: 261.6/100 PY; Year 2: 235.7/100 PY). In Year 2, the most common TEAEs were hidradenitis (26.6/100 PY), coronavirus infection (23.1/100 PY), and oral candidiasis (12.5/100 PY). Most patients achieved HiSCR50/75/90/100 at Year 2 (85.4%/77.1%/57.6%/44.2%). Improvements in skin pain and HRQoL achieved at Year 1 were sustained at Year 2.
LIMITATIONS: Patient inclusion criteria limit real-world generalizability.
CONCLUSIONS: Bimekizumab was well-tolerated up to 2 years; no new safety signals were identified with longer exposure. Bimekizumab provided deep, durable improvements in clinical and HRQoL outcomes.