Efficacy of rocatinlimab for moderate-to-severe atopic dermatitis

In their multicentre, double-blind, placebo-controlled phase 2b study, Emma Guttman-Yassky and colleagues showed the efficacy and safety of subcutaneous rocatinlimab versus subcutaneous placebo for the treatment of moderate-to-severe atopic dermatitis.1Guttman-Yassky E Simpson EL Reich K 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: 204-214Summary Full Text Full Text PDF PubMed Scopus (31) Google Scholar Although the findings of this study are novel and encouraging, there are a few limitations that require elucidation. A 2018 review on the epidemiology of atopic dermatitis indicated a higher prevalence of atopic dermatitis among Asian and Black individuals compared with White individuals worldwide.2Kaufman BP Guttman-Yassky E Alexis AF Atopic dermatitis in diverse racial and ethnic groups—variations in epidemiology, genetics, clinical presentation and treatment.Exp Dermatol. 2018; 27: 340-357Crossref PubMed Scopus (209) Google Scholar 171 (60%) of the 267 patients in Guttman-Yassky and colleagues' randomised controlled trial were of Asian descent. However, only 13 (6%) patients in the study population were of Black or African American descent, which does not represent the overall prevalence of atopic dermatitis. Patients of different races can have different genetic polymorphisms that influence symptoms and response to current therapies.3Bhattacharya T Silverberg JI Efficacy of systemic treatments for atopic dermatitis in racial and ethnic minorities in the United States.JAMA Dermatol. 2014; 150: 1232-1234Crossref PubMed Scopus (31) Google Scholar The breakdown of participants in this clinical trial could impair the generalisability of the study findings. The authors state that the incidence of serious adverse events ranged from 2% to 6% in the rocatinlimab groups and was 2% in the placebo group. The scarcity of results beyond 20 weeks could pose a concern for the long-term safety of rocatinlimab. Additionally, nearly 25% of patients in the treatment group reported fever and chills, which the investigators classified as injection reactions. An understanding of patient sentiments regarding injections and side-effects to ascertain potential compliance at home could be beneficial for the external validity of the study. JJW is or has been an investigator, consultant, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, DermTech, Dr Reddy's Laboratories, Eli Lilly, EPI Health, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, and Zerigo Health. All other authors declare no competing interests. For more on the French National Health Strategy 2018–2022 see https://sante.gouv.fr/IMG/pdf/dossier_sns_2017_synthesev6-10p_anglaisv2.pdf For more on the French National Health Strategy 2018–2022 see https://sante.gouv.fr/IMG/pdf/dossier_sns_2017_synthesev6-10p_anglaisv2.pdf An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b studyPatients treated with rocatinlimab had progressive improvements in atopic dermatitis, which was maintained in most patients after treatment discontinuation. Treatment was well tolerated. Full-Text PDF Efficacy of rocatinlimab for moderate-to-severe atopic dermatitis – Authors' replyWe thank Shivali Devjani and colleagues for their Correspondence in response to our Article1 on the efficacy and safety of subcutaneous rocatinlimab for moderate-to-severe atopic dermatitis. In their Correspondence, the authors point out unequal racial representation in the study in relation to the racial distribution of atopic dermatitis in real-world settings. We agree that the higher number of Asian patients compared with Black patients studied in this phase 2b study could limit generalisability of the findings. Full-Text PDF