Long-Term Safety of Dupilumab in Adults with Moderate to Severe Atopic Dermatitis

The use of systemic immunosuppressants to treat moderate to severe atopic dermatitis (AD) for extended periods raises safety concerns. An open-label extension study (NCT01949311) has demonstrated acceptable safety of dupilumab (Dupixent) in adult patients for up to 5 years. Results were presented in a poster session at the 2023 Fall Clinical Dermatology Conference in Las Vegas, Nevada.

The LIBERTY AD OLE trial involved a multicenter, phase 3 study that extended for up to 5 years. Adult patients with moderate to severe AD, who had previously participated in dupilumab clinical trials, received a weekly dose of 300 mg. Some patients transitioned to 300 mg every 2 weeks (q2w) to align with approved dosage. Concomitant treatments, including topical corticosteroids (TCS) and topical calcineurin inhibitors, were allowed. The study lacked a control arm, so data from the LIBERTY AD CHRONOS trial provided comparative 52-week safety results for patients receiving dupilumab 300 mg qw plus TCS.

The OLE trial included 2677 patients, with 60.2% being male and 72.3% identifying as White. The mean age of patients was 39.2 years, and the average duration of AD was 29.9 years. Baseline scores for Eczema Area and Severity Index, Investigator’s Global Assessment, and Peak Pruritus Numerical Rating Scale were 16.4, 2.7, and 5.0, respectively.

The safety profile of long-term dupilumab treatment up to 5 years was found to be acceptable and consistent with previous findings from placebo-controlled studies. Exposure-adjusted incidence rates of treatment-emergent adverse events (TEAEs) did not increase over time and were lower than those reported in the 3- and 4-year analyses of the OLE trial and a previous 52-week placebo-controlled trial.

The results from this 5-year open-label extension trial affirm the safety of dupilumab in adults with moderate to severe AD. The findings provide valuable insights for clinicians considering long-term treatment options for their patients. Continued monitoring and research in this area will further enhance our understanding of dupilumab's safety profile.

Reference

Beck L, Bissonnette R, Deleuran M, et al. Safety of long-term dupilumab treatment in adults with moderate-to-severe results from a 5-year open-label extension trial. Poster presented at: 2023 Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, Nevada.