34367 Safety of long-term dupilumab treatment in adults with moderate-to-severe atopic dermatitis: Results from an open-label extension (OLE) trial up to 4 years

Abstract

Background: Atopic dermatitis (AD) is a chronic systemic inflammatory disease requiring long-term management. We extend the dupilumab safety profile in patients with moderate-to-severe AD to 204 weeks. Methods: The OLE (NCT01949311), with an initial duration of 3 years, enrolled adults with moderate-to-severe AD who participated in any dupilumab parent study. Protocol amendments allowed for patient re-entry and treatment extension for up to 5 years. 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 treatments were permitted. Data shown are for the overall study population (N = 2,677). Results: 2207/1065/557/362/352 patients completed up to 52/100/148/172/204 weeks of treatment. 240 patients had treatment duration of >204 weeks. Most withdrawals (59.5%) were due to dupilumab approval/commercialization; 8.4%/4.3% withdrew due to adverse events (AEs)/lack of efficacy. Exposure-adjusted incidence rates of treatment-emergent AEs (TEAEs) were lower in this OLE vs the 300c mg weekly+topical corticosteroid arm of the 1-year CHRONOS trial (167.5 vs 322.4 number of patients/100 patient-years). 10.4% of patients had serious TEAEs; 9.8%, severe TEAEs; 1.2%, ≥1 serious TEAE related to study drug; and 3.7%, TEAEs resulting in permanent drug discontinuation. The most common TEAEs were nasopharyngitis (28.9%) and conjunctivitis (20.0%, including allergic/bacterial/viral/atopic keratoconjunctivitis). The most common severe TEAEs by MedDRA Preferred Term were dermatitis atopic (0.9%) and conjunctivitis (0.7%). 95% patients with conjunctivitis TEAEs were reported as mild/moderate; 87% of conjunctivitis events were recovered/resolved. Conclusions: This analysis extends to 4 years the previous findings demonstrating dupilumab’s acceptable long-term safety profile.