Dupilumab provides long-term efficacy for up to 4 years in an open-label extension study of adults with moderate-to-severe atopic dermatitis

Introduction (contexte de la recherche) Patients with moderate-to-severe atopic dermatitis (AD) often have an inadequate response to topical therapies. We present long-term efficacy of dupilumab up to 4 years in adults with moderate-to-severe AD from an open-label extension (OLE) study (LIBERTY AD OLE, NCT01949311 ). Adults (≥ 18 years) with moderate-to-severe AD from any dupilumab parent study (phase 1–3) were enrolled into the long-term, multicenter, OLE with an initial duration of 3 years (extended up to 5 years in certain countries). Initially, patients received 300 mg dupilumab weekly; in 2019, patients transitioned to dupilumab 300 mg every 2 weeks (approved dose). Concomitant treatments for AD, including topical corticosteroid and topical calcineurin inhibitors, were permitted. Data shown are for the overall study population. Of 2677 patients enrolled in the OLE, 2207 completed treatment up to week 52, 1065 up to week 100, 557 up to week 148, 362 up to week 172, and 352 up to week 204. 240 patients had treatment duration > 204 weeks. Most withdrawals (810 [59.5%]) during the OLE study period were due to dupilumab approval and commercialization in the patients’ country of enrolment; 114 (8.4%) withdrew due to adverse events (AEs) and 58 (4.3%) due to lack of efficacy. At week 204, 91% of patients achieved a 75% reduction in Eczema Area and Severity Index (EASI) from parent study baseline (PSBL), 76% of patients achieved a 90% reduction in EASI from PSBL, and 70.8% of patients achieved a ≥ 4-point reduction in the Peak Pruritus Numerical Rating Scale score from PSBL. A total of 2273 (84.9%) patients reported treatment-emergent AEs, and 99 (3.7%) patients discontinued treatment permanently due to reported AEs. Dupilumab had an acceptable safety profile. Long-term dupilumab treatment showed sustained efficacy with durable and progressive improvements in AD signs and symptoms in adults with moderate-to-severe AD up to 204 weeks. Dupilumab was generally well tolerated with an acceptable safety profile.