Long-Term Dupilumab Efficacy and Safety in Pediatric Patients: A Real-World Experience Over 2 Years

Abstract

In this exploratory retrospective, single-center observational study, we evaluated the long-term effectiveness and safety of dupilumab in 42 pediatric patients with moderate-to-severe atopic dermatitis (AD), including individuals with rare genetic syndromes. We also explored the feasibility of seasonal dosing modulation. During the summer months (June–August), patients underwent an extended dupilumab dosing interval (from every 2 weeks to every 3 weeks or from every 4 weeks to every 5 weeks), taking advantage of the typical seasonal improvement in AD symptoms. At 24 months, mean EASI scores were significantly reduced from 21.2 at baseline to 1.6 (p < 0.0001), and substantial improvements were observed in both P-NRS and sleep quality, with 95% of patients achieving at least a 50% improvement by week 16. Although the summer dosing extension maintained disease control in all patients, 21 (50%) required a return to standard dosing in autumn to sustain efficacy. Dupilumab was well-tolerated, with conjunctivitis being the sole adverse event, reported in 9.5% of patients and resolving without the need to discontinue therapy. These results underscore dupilumab’s sustained efficacy and safety in a complex pediatric population and support the potential of seasonal dose modulation as a tailored treatment strategy.