Atopic dermatitis (AD) is a chronic inflammatory disease with a high clinical burden and risk of persistence in pediatric patients. To assess safety and efficacy of treatment with dupilumab for up to 2 years in infants and young children with AD. Patients aged 6 months to 5 years who had previously participated in parent studies LIBERTY AD PRESCHOOL Part A or B (NCT03346434), with moderate-to-severe AD at parent study baseline, were enrolled in the ongoing LIBERTY AD PED open-label extension (OLE) study (NCT02612454). Patients initially received weight-based dupilumab (3 or 6 mg/kg once a week); following protocol amendment, patients were switched to a weight-tiered dose every 4 weeks (200 mg for patients weighing 5 to < 15kg; 300 mg for patients weighing 15 to < 30kg). The use of concomitant medications (topical corticosteroids, antihistamines, and topical calcineurin inhibitors) was permitted without restriction, but patients were not permitted to use systemic medication for AD except as rescue treatment. Analyses were descriptive, with no formal statistical hypothesis. This analysis included 180 patients, of whom 106 completed the week 104 visit. A total of 87.8% patients experienced treatment-emergent adverse events (TEAEs; 24.4% mild, 52.2% moderate, 11.1% severe). One serious, drug-related TEAE (pinworm infection) did not lead to treatment discontinuation and resolved over time. One drug-related event of severe urticaria led to permanent treatment discontinuation but was not considered serious and resolved over time. By week 104, 92.1% patients achieved a 75% reduction in Eczema Area and Severity Index from parent study baseline, and the mean reduction in body surface area affected by AD was 49.0% from parent study baseline. In this OLE study, treatment with dupilumab for up to 2 years in infants and young children with AD demonstrated sustained efficacy with a safety profile consistent with prior studies, supporting its long-term continuous use in pediatric patients. ClinicalTrials.gov Identifier: NCT02612454 Atopic dermatitis (AD), a type of eczema, is a common inflammatory skin disease in children worldwide. Children with moderate-to-severe AD often need long-term treatment, as the disease may continue into adolescence and adulthood. In a previous study, treatment with dupilumab for up to 1 year provided sustained benefits and safety in children aged 6 months to 5 years with moderate-to-severe AD. Patients within the same study had the option to continue treatment with dupilumab for up to 2 years, in which they received 200 or 300 mg of dupilumab (depending on body weight) every 4 weeks. Throughout the 2 years, 88% of patients reported health issues, mostly mild or moderate and not related to treatment with dupilumab. Only two patients left the study owing to health issues, including one patient who developed a nonserious skin rash event related to dupilumab that resolved over time. Among the patients with health issues that were considered side effects of dupilumab, only one event was considered serious (pinworm infection), but it did not lead to interruption of treatment. By the end of the 2 years, 92% of patients achieved a 75% improvement in their extent and severity of disease since the beginning of treatment. On average, the body surface area affected by AD reduced by 49%. Most patients also reported improvements in quality-of-life measures. Overall, treatment with dupilumab for up to 2 years was associated with clinical benefits and consistent safety for infants and children with moderate-to-severe AD.
Paller et al. (Sat,) studied this question.