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

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. ORCID: https://orcid.org/0000-0002-5257-1142, Morita, Akimichi, Deherder, Delphine, Crater, Christina, Rolleri, Robert L., Vaux, Tom, Lambert, Jérémy, Lukowski, Bartosz and Bechara, Falk G. 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. Journal of The American Academy of Dermatology 10.1016/j.jaad.2025.11.031

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Abstract

Background Hidradenitis suppurativa (HS) 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 BE HEARD I&II phase 3 trials and their open-label extension (OLE) BE HEARD Extension were pooled to assess the safety and efficacy of bimekizumab in patients with moderate to severe HS 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 556 patients entered the OLE; 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.

Item Type:	Article
Date Type:	Published Online
Status:	In Press
Schools:	Schools > Medicine
Additional Information:	Rights Retention Strategy policy applied
Publisher:	Elsevier
ISSN:	0190-9622
Date of First Compliant Deposit:	24 November 2025
Date of Acceptance:	12 November 2025
Last Modified:	25 Nov 2025 16:00
URI:	https://orca.cardiff.ac.uk/id/eprint/182587

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