Long-term use of systemic immunosuppressants for atopic dermatitis (AD) is not recommended due to safety concerns. A long-term study of dupilumab for the treatment of moderate-to-severe AD demonstrated a decline in AD symptoms, and the treatment had a favorable risk-benefit profile with no new safety concerns. The results of the study were published as part of the American Academy of Dermatology Virtual Meeting Experience 2020.
Researchers assessed three-year outcomes for patients who participated in the ongoing, multicenter, phase III, open-label extension LIBERTY AD study. The study evaluated the long-term safety and efficacy of repeat doses of dupilumab 300 mg weekly for up to 148 weeks in adults with moderate-to-severe AD who had previously participated in dupilumab studies, including early phase Ib trials, or had been screened for a phase III study but were not included due to randomization closure. A total of 2,678 patients (mean age, 39.2 years; 60.2% male; 72.3% white) were enrolled, 2,677 of whom were treated with dupilumab.
Overall, dupilumab was well tolerated, with 3.5% of patients discontinuing treatment due to treatment-related adverse events (AEs). Long-term safety (primary endpoint) was consistent with previously observed dupilumab studies, and no new safety signals were detected with long-term dupilumab treatment. Exposure-adjusted incidence rates of the most common AEs were lower in the open-label extension study than in the LIBERTY AD CHRONOS treatment group. In total, 1,325 patients withdrew from the study; 807 patients withdrew due to study termination by the sponsor upon regulatory approval and commercialization of the study drug.
At week 148 (n=58), 74.1% of patients had an Investigator’s Global Assessment score (IGA) of ≤1 (defined as clear or almost clear skin), and 94.8% had an IGA score ≤2 (defined as mild). Mean percent change in Eczema Area and Severity Index (EASI) from parent study baseline to week 148 (n=58) was –95.4%, with 96.6% of patients achieving EASI-75. Additionally, mean EASI was 1.4 at week 148.
Mean percent change in weekly averaged daily Peak Pruritus Numerical Rating Scale (NRS) from parent study baseline to week 148 was –65.4%, while 75.0% of patients achieved ≥3-point improvement in Peak Pruritus NRS or a Peak Pruritus NRS score of zero. Mean weekly averaged daily Peak Pruritus NRS score was 2.2 at week 148, corresponding to no or very mild skin lesions and pruritus.
Blauvelt A, Hussain I, Beazley B, et al. Dupilumab Treatment for up to 3 Years Demonstrates Sustained Efficacy in Adult Patients With Moderate-to-Severe Atopic Dermatitis: Results From LIBERTY AD Adult OLE. Presented during the AAD Virtual Meeting Experience 2020, June 12-14, 2020.