AUTHOR=Saeki Hidehisa , Usami Makiko , Suzuki Katsuhisa , Mochizuki Michika , Arima Kazuhiko 

TITLE=Real-world safety and effectiveness of dupilumab for the treatment of atopic dermatitis: two-year post-marketing surveillance in Japan

JOURNAL=Journal of Cutaneous Immunology and Allergy

VOLUME=Volume 8 - 2025

YEAR=2025

URL=https://www.frontierspartnerships.org/journals/journal-of-cutaneous-immunology-and-allergy/articles/10.3389/jcia.2025.14794

DOI=10.3389/jcia.2025.14794

ISSN=2574-4593

ABSTRACT=BackgroundDupilumab, a human anti-interleukin-4 receptor α monoclonal antibody, was approved in Japan in 2018 as an add-on to topical therapy for atopic dermatitis (AD) inadequately controlled with conventional therapies in patients aged ≥15 years. A regulatory-mandated post-marketing surveillance (PMS) of the real-world safety and effectiveness of dupilumab was conducted.MethodsPatients with AD who initiated dupilumab treatment between July 2018 and June 2020 in Japan were monitored for 2 years. Safety outcomes included adverse drug reactions (ADRs) and some adverse events (AEs). Effectiveness outcomes included changes in the Eczema Area and Severity Index (EASI), Investigator’s Global Assessment (IGA), and pruritus numerical rating scale (NRS) scores.ResultsOf the 989 patients registered from 184 sites, 962 and 892 were included in the safety and effectiveness analysis sets, respectively. At 2 years, the incidence rates of any ADR and serious ADRs (16.8% and 0.8%, respectively) were similar to those at the 1-year interim analysis. The most common ADRs were conjunctivitis (7.1%), allergic conjunctivitis (4.2%), and blepharitis (0.8%). For effectiveness at 2 years, significant improvements from baseline were observed for mean ± standard deviation EASI (from 30.1 ± 13.2 to 4.0 ± 7.0), IGA (from 3.4 ± 0.5 to 1.4 ± 0.8), and weekly peak pruritus NRS (from 6.9 ± 2.1 to 1.8 ± 1.6) scores (all P < 0.001 vs. baseline).LimitationsThe observational, non-comparative design precludes establishing causality, with concomitant AD treatments potentially confounding dupilumab’s effectiveness assessment and non-compulsory follow-up visits may have introduced selection bias.ConclusionThe real-world PMS in Japan confirmed that dupilumab was well-tolerated, demonstrated an acceptable safety profile and was associated with sustained improvements in AD signs and symptoms over 2 years.Trial RegistrationUMIN-CTR (https://www.umin.ac.jp/ctr/index.htm), Identifier: UMIN000032807.