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 - 13/12/25

Doi : 10.1016/j.jaad.2025.11.031

Christopher J. Sayed, MD ^a,^b,^⁎ , Brian Kirby, MD ^b,^c, Amit Garg, MD ^d, Haley B. Naik, MD ^e, Alexa B. Kimball, MD, MPH ^f, Christos C. Zouboulis, MD, PhD ^b,^g, Gregor B.E. Jemec, MD, DMSc ^b,^h,ⁱ, Georgios Kokolakis, PhD ^j, John R. Ingram, DM ^b,^k, Akimichi Morita, MD, PhD ^l, Delphine Deherder, MSc ^m, Christina Crater, MD ⁿ, Robert L. Rolleri, PharmD ⁿ, Tom Vaux, MSc ^o, Jérémy Lambert, PhD ^p, Bartosz Lukowski, PhD ^q, Falk G. Bechara, MD ^r,^s
^a Department of Dermatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina
^b European Hidradenitis Suppurativa Foundation (EHSF) e.V., Dessau, Germany
^c St Vincent's University Hospital, Elm Park and the Charles Institute, University College Dublin, Dublin, Republic of Ireland
^d Department of Dermatology, Northwell, New Hyde Park, New York
^e Department of Dermatology, University of California, San Francisco, California
^f Department of Dermatology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts
^g Departments of Dermatology, Venereology, Allergology and Immunology, Staedtisches Klinikum Dessau, Brandenburg Medical School Theodor Fontane and Faculty of Health Sciences Brandenburg, Dessau, Germany
^h Department of Dermatology, Herlev-Gentofte Hospital, University Hospital, Herlev, Denmark
ⁱ Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
^j Psoriasis Research and Treatment Center, Clinic of Dermatology, Venereology, and Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
^k Department of Dermatology & Academic Wound Healing, Division of Infection and Immunity, Cardiff University, Cardiff, UK
^l Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
^m UCB, Braine-l'Alleud, Belgium
ⁿ UCB, Morrisville, North Carolina
^o UCB, Slough, UK
^p UCB, Colombes, France
^q Vedim/UCB, Warsaw, Poland
^r Department of Dermatology, Venereology, and Allergology, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany
^s Department of Dermatology, ICH – International Center for Hidradenitis Suppurativa/Acne Inversa, Ruhr-University Bochum, Bochum, Germany

^∗Correspondence to: Christopher J. Sayed, MD, Department of Dermatology, University of North Carolina School of Medicine, 410 Market St #400A, CB# 7715, Chapel Hill, NC 27516.410Market St #400ACB# 7715Chapel HillNC27516

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Saturday 13 December 2025

Abstract

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.

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Key words : BE HEARD, bimekizumab, cytokines, hidradenitis suppurativa, IL-17 inhibitors, inflammatory skin disease, open-label extension, randomized controlled trial

Abbreviations used : DT, EAIR, HRQoL, HS, IBD, IL, MACE, SIB, TEAE

Plan

Introduction

Methods

Study design and treatment

Baseline characteristics

Safety

Efficacy

Discussion

	Funding sources: UCB contributed to study design, participated in data collection, completed the data analysis, and participated in data interpretation. UCB participated in writing, review, and approval of the manuscript. All authors had full access to the data, reviewed and approved the final version, and were responsible for the decision to submit for publication. A medical writing agency, employed by UCB, assisted with manuscript preparation under the authors' direction.
	Patient consent: All the results presented in this article are in aggregate form, and no personally identifiable information was used for this study.
	IRB approval status: Reviewed and approved by the relevant institutional review board (Pro00050006/18 Mar 2021).
	Data sharing statement: Underlying data from this manuscript can be requested by qualified researchers 6 months after product approval in the United States of America and Europe, or global development is discontinued, and 18 months after trial completion. Investigators can request access to anonymized individual patient-level data and redacted trial documents, which can include analysis-ready datasets, study protocol, annotated case-report form, statistical analysis plan, dataset specifications, and clinical study report. Before use of the data, proposals need to be approved by an independent review panel at Vivli.org/ and a signed data-sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password-protected portal.