Dupilumab Efficacy and Safety Assessment in the Treatment of Atopic Dermatitis in Pediatric Patients: A Systematic Review

Abstract

Background/Objectives

Atopic dermatitis (AD) is a chronic inflammatory skin condition, commonly first occurring in early childhood. Although many treatments have currently been established, their effectiveness often varies, and it is not always adequate. The first biologic agent approved in the pediatric population, in severe AD cases, is dupilumab. In this review we aim to present the current data on dupilumab effectiveness and safety in the pediatric population.

Methods

Systematic search was conducted throughout PubMed, ScienceDirect, and clinicaltrials.gov, from which three clinical trials and four real-life studies were included. The studies were analyzed in terms of drug effectiveness (using EASI, IGA and SCORAD scoring systems) and safety profile (presence and occurrence of adverse events).

Results

EASI, SCORAD, and IGA scores were significantly improved in patients receiving dupilumab treatment irrespective of dosage. Conjunctivitis was the most consistently and commonly reported adverse event in both clinical trials (relative risk; RR = 2.4, 95% confidence interval [CI] [1.20, 4.84], p = 0.01) and real-life studies (10.8% of patients). Injection-site reactions and nasopharyngitis demonstrated an increased, yet nonsignificant RR. Compared to placebo, dupilumab exhibited a reduced RR of 36% in AD exacerbations (95% CI [0.43, 0.94], p = 0.0234) and 44% in skin infections (95% CI [0.36, 0.88], p = 0.0106).

Conclusions

Dupilumab appears to be a promising drug in the treatment of moderate to severe AD in pediatric population, with noticeable improvement in outcome scores. Among the adverse events, conjunctivitis is the most common; however, no long-term or life-threatening events were reported.