Introduction: Dupilumab is a safe and effective biological drug that revolutionized the treatment of atopic dermatitis (AD). Concerning adverse events (AEs), the most commonly reported included ocular involvement, nasopharyngitis, and injection site reactions in clinical trials. Anyway, its use in daily practice is revealing novel dupilumab-induced manifestations.
Areas covered: Relevant English literature (real-life studies, case series, reviews, and meta-analyses) regarding real-life adverse events induced by dupilumab were searched for up to 10 June 2023.
Expert opinion: Dupilumab is an effective treatment for AD, showing favorable safety profile since no routine laboratory monitoring is recommended. However, several cutaneous and extracutaneous AEs have been reported in real-life setting expanding the pool emerged from clinical trials. In detail, dupilumab may determine de-novo onset or exacerbation of preexisting conditions, whose pathogenesis is still unclear and seems to involve Th1/Th2 and Th2/Th17 immune-response imbalance. Also, the heterogeneity and the variable onset time of AEs with respect to dupilumab initiation warrant a thorough patients' history collection and strict short- and long-term monitoring. Finally, the most appropriate management of patients with AEs related to dupilumab should take into consideration efficacy for AD as well as severity and nature of the AE, available treatment and patients' preferences.
Keywords: Adverse event; dupilumab; pathogenesis; real-life; safety.