34358 Long-term efficacy of dupilumab in adults with moderate-to-severe atopic dermatitis (AD): Results from an open-label extension (OLE) trial up to 4 years

Abstract

Background: AD is a chronic systemic inflammatory disease often requiring long-term management. Here, we present long-term efficacy of dupilumab up to 4 years in adult patients with moderate-to-severe AD. Methods: The OLE (NCT01949311), with an initial duration of 3 years, enrolled adults with moderate-to-severe AD who participated in a dupilumab parent study. Protocol amendments extended the maximum treatment duration to 5 years. Following protocol amendments in 2017 and 2018, 114 and 272 patients re-entered the trial; 103 and 207 patients had a treatment interruption of >8 weeks between Weeks 148 and 164. Patients were treated with 300 mg dupilumab weekly. In 2019, patients transitioned to 300 mg every 2 weeks to align with approved dosage. Concomitant topical anti-inflammatory treatments were permitted. Data shown are for the overall study population (N = 2677). Results: 2207/1065/557/362/352 patients completed up to 52/100/148/172/204 weeks of treatment. 240 patients had treatment duration >204 weeks. Most withdrawals (59.5%) were due to dupilumab approval; 8.4%/4.3% withdrew due to adverse events/lack of efficacy. At Week 204, 95%/91%/76% of patients achieved 50%/75%/90% reductions in Eczema Area and Severity Index from parent study baseline (PSBL). 78.7%/70.8% of patients achieved ≥3/≥4-point reduction in the Peak Pruritus Numerical Rating Scale score from PSBL at Week 204. Treatment-emergent adverse events were reported in 2273 (84.9%) patients, with 99 (3.7%) permanently discontinuing treatment. Conclusions: Long-term dupilumab treatment showed sustained efficacy substantiated by improvement of AD signs and symptoms in patients with moderate-to-severe AD up to 204 weeks. Safety data were consistent with prior studies.