OX40/OX40L Inhibitors in Atopic Dermatitis: Current Evidence on Short-term Safety

Authors

  • Kian Karimian National Allergy Research Centre, Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Herlev, Denmark
  • Daniel Isufi Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark; Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark
  • Mikkel Bak Jensen National Allergy Research Centre, Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Herlev, Denmark; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  • Raj Chovatiya Department of Medicine, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, IL, United States; Center for Medical Dermatology and Immunology Research, Chicago, IL, USA, United States
  • Christopher G. Bunick Department of Dermatology, Yale School of Medicine, New Haven, CT, United States; Program in Translational Biomedicine, Yale School of Medicine, New Haven, CT, United States
  • Tiago Torres Department of Dermatology, Centro Académico Clínico ICBAS/Santo António, Porto, Portugal; Instituto de Ciências Biomédicas Abel Salazar, University of Porto, Porto, Portugal.
  • Jakob Ferløv Baselius Schwensen National Allergy Research Centre, Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Herlev, Denmark; Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  • Nikolai Loft Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark; Copenhagen Research Group for Inflammatory Skin, Herlev and Gentofte Hospital, Hellerup, Denmark

DOI:

https://doi.org/10.2340/actadv.v106.adv-2026-0665

Keywords:

Adverse events, Atopic dermatitis, Biologics, OX40/OX40L Inhibitors, Phase 2 trial, Phase 3 trial

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References

Guttman-Yassky E, Simpson EL, Reich K, Kabashima K, Igawa K, Suzuki T, et al. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. Lancet 2023; 401: 204–214. DOI: https://doi.org/10.1016/S0140-6736(22)02037-2

Weidinger S, Bieber T, Cork MJ, Reich A, Wilson R, Quaratino S, et al. Safety and efficacy of amlitelimab, a fully human nondepleting, noncytotoxic anti-OX40 ligand monoclonal antibody, in atopic dermatitis: results of a phase IIa randomized placebo-controlled trial. Br J Dermatol 2023; 189: 531–539. DOI: https://doi.org/10.1093/bjd/ljad240

Rewerska B, Sher LD, Alpizar S, Pauser S, Pulka G, Mozaffarian N, et al. Phase 2b randomized trial of OX40 inhibitor telazorlimab for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Glob 2024; 3: 100195. DOI: https://doi.org/10.1016/j.jacig.2023.100195

Weidinger S, Blauvelt A, Papp KA, Reich A, Lee CH, Worm M, et al. Phase 2b randomized clinical trial of amlitelimab, an anti-OX40 ligand antibody, in patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol 2025; 155: 1264–1275. DOI: https://doi.org/10.1016/j.jaci.2024.10.031

Guttman-Yassky E, Pavel AB, Zhou L, Estrada YD, Zhang N, Xu H, et al. GBR 830, an anti-OX40, improves skin gene signatures and clinical scores in patients with atopic dermatitis. J Allergy Clin Immunol 2019; 144: 482–493. DOI: https://doi.org/10.1016/j.jaci.2018.11.053

Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HCH, Chovatiya R, et al. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet 2026; 407: 53–66. DOI: https://doi.org/10.1016/S0140-6736(25)01865-3

Simpson EL, Gooderham M, de Bruin MS, Armstrong A, Warren RB, Geng B, et al. 223 Rocatinlimab with concomitant topical therapy significantly improved clinical signs and symptoms of atopic dermatitis in adults: results from the phase 3 ROCKET-SHUTTLE Trial. J Invest Dermatol 2025; 145: e66. DOI: https://doi.org/10.1016/j.jid.2025.09.227

Kirin K. Kyowa Kirin announces discontinuation of rocatinlimab clinical trials. 2026. [cited 2026 April 20]. Available from: https://ir.kyowakirin.com/en/news/news-2560625228719159862/main/0/link/e20260303_01.pdf

Sanofi. Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews. 2026. [cited 2026 August 31]. Available from: https://www.sanofi.com/assets/dotcom/pressreleases/2026/2026-07-24-05-30-00-3332696-en.pdf

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Published

2026-10-12

How to Cite

Karimian, K., Isufi, D., Jensen, M. B., Chovatiya, R., Bunick, C. G., Torres, T., … Loft, N. (2026). OX40/OX40L Inhibitors in Atopic Dermatitis: Current Evidence on Short-term Safety. Acta Dermato-Venereologica, 106, adv–2026. https://doi.org/10.2340/actadv.v106.adv-2026-0665

Issue

Vol. 106 (2026)

Section

Short Communication

Categories

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Copyright (c) 2026 Kian Karimian, Daniel Isufi, Mikkel Bak Jensen, Raj Chovatiya, Christopher G. Bunick, Tiago Torres, Jakob Ferløv Baselius Schwensen, Nikolai Loft

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