Efficacy and Safety of Nemolizumab at Week 48: Results from the Maintenance Phase of Two Global Phase 3 Pivotal Studies (ARCADIA 1&2) in Patients with Moderate-to-Severe Atopic Dermatitis

Authors

  • Andreas Wollenberg Department of Dermatology and Allergy, University Hospital Augsburg, Augsburg, Germany; Comprehensive Center for Inflammation Medicine, University of Luebeck, Luebeck, Germany; Department of Dermatology and Allergy, Ludwig-Maximilian University of Munich, Munich, Germany
  • Jonathan I. Silverberg Department of Dermatology, George Washington University School of Medicine and Health Sciences, Washington, DC, United States
  • Franz J. Legat Department of Dermatology, Medical University of Graz, Graz, Austria
  • Marie Tauber Department of Allergy and Clinical Immunology, Lyon Sud Hospital, Hospices Civils de Lyon, Inserm U1111 Centre International de Recherche en Infectiology, Lyon, France
  • Vivian T. Laquer First OC Dermatology Research, Fountain Valley, CA, United States
  • April W. Armstrong Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States
  • Andrew E. Pink St. John’s Institute of Dermatology, Guy’s & St. Thomas' NHS Foundation Trust, London, United Kingdom
  • Luigi Naldi Academic Research Centre, Centro Studi GISED, Bergamo, Italy
  • Grażyna Pulka School of Medicine, Jagiellonian University Medical College, Kraków, Poland
  • Jacek Zdybski Klinika Zdybski Dermedic, Ostrowiec Świętokrzyski, Poland
  • Athanasios Tsianakas Department of Dermatology, Fachklinik Bad Bentheim, Bad Bentheim, Germany
  • Jorge Diaz Doral Medical Research, Doral, FL, United States
  • Inese Svarca Health and Aesthetics Private Ambulatory Practice, Riga, Latvia
  • Jennifer Beecker Division of Dermatology, Ottawa Hospital, Ottawa, ON, Canada; Ottawa Hospital Research Institute, Ottawa, ON, Canada; University of Ottawa, Ottawa, ON, Canada; Probity Medical Research, Waterloo, ON, Canada
  • Galina Balakirski Center for Dermatology, Allergology and Dermatosurgery, Helios University Hospital Wuppertal, University of Witten/Herdecke, Heusnerstraße, Wuppertal, Germany
  • Sylvia Pauser Klinische Forschung Osnabrück, Osnabrück, Germany
  • Liliana Ulianov Galderma R&D, Lausanne, Switzerland
  • Anna Ryzhkova Galderma R&D, Zug, Switzerland
  • Jean-Loup Machu Galderma R&D, Lausanne, Switzerland
  • Christophe Piketty Galderma R&D, Zug, Switzerland

DOI:

https://doi.org/10.2340/actadv.v106.adv-2025-0085

Keywords:

atopic dermatitis, Investigator’s Global Assessment, Eczema Area and Severity Index, itch, quality of life, sleep disturbance

Abstract

Nemolizumab with background topical therapy (corticosteroids±calcineurin inhibitors) significantly improved skin lesions, itch and sleep in two global phase 3 trials (ARCADIA 1&2) in adolescents and adults with moderate-to-severe atopic dermatitis through week (W)16. Efficacy and safety of nemolizumab, combined with background topical therapy, were evaluated for an additional 32 weeks
(W16–W48) with a focus on maintained skin responses in clinical responders (patients achieving Investigator’s Global Assessment [IGA] score of 0/1 [clear/almost clear] or ≥75% improvement in Eczema Area and Severity Index [EASI-75] at W16). At W16, clinical responders (N=507) to nemolizumab every 4 weeks (Q4W) were rerandomized (1 : 1 : 1) to receive nemolizumab 30 mg-Q4W/-Q8W/placebo (nemolizumab-withdrawal) subcutaneously with background topical therapy. At W48, 61.5% (strata-adjusted difference versus
nemolizumab-withdrawal group [Δ], 11.8% [95% CI 1.3–22.3]) and 76.3% (Δ, 12.4% [95% CI 2.7– 22.0]) of patients in nemolizumab-Q4W; 60.4% (Δ, 10.7% [95% CI 0.3–21.0]) and 75.7% (Δ, 11.8% [95% CI 2.1–21.5]) in nemolizumab-Q8W; and 49.7% and 63.9% in nemolizumab-withdrawal group maintained response rate for IGA success and EASI-75, respectively. The percentage of patients who experienced ≥1 adverse events were similar across the groups (range: 53.5%–58.3%). Up to W48, skin responses were maintained without notable differences in the safety profile of both nemolizumab dosing regimens.

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Published

2026-06-10

How to Cite

Wollenberg, A., Silverberg, J. I., Legat, F. J., Tauber, M., Laquer, V. T., Armstrong, A. W., … Piketty, C. (2026). Efficacy and Safety of Nemolizumab at Week 48: Results from the Maintenance Phase of Two Global Phase 3 Pivotal Studies (ARCADIA 1&2) in Patients with Moderate-to-Severe Atopic Dermatitis. Acta Dermato-Venereologica, 106, adv–2025. https://doi.org/10.2340/actadv.v106.adv-2025-0085

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Vol. 106 (2026)

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