Safety and Efficacy of Treatment with Dupilumab for up to 2 Years in Infants and Young Children with Atopic Dermatitis.

BACKGROUND

Atopic dermatitis (AD) is a chronic inflammatory disease with a high clinical burden and risk of persistence in pediatric patients.

OBJECTIVE

To assess safety and efficacy of treatment with dupilumab for up to 2 years in infants and young children with AD.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02612454.