Regeneron and Sanofi announced that the Phase 3 study, LIBERTY AD CHRONOS, met its primary and key secondary endpoints for dupilumab in the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients.
LIBERTY AD CHRONOS is a one-year, randomized, Phase 3 study evaluating the efficacy and safety of dupilumab with topical corticosteroids (TCS) vs. TCS alone in 740 patients with moderate-to-severe AD who are inadequately controlled by TCS with or without topical calcineurin inhibitors (TCI). Patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe), the Eczema Area and Severity Index (EASI) and other measures. Entry criteria for the study required a baseline IGA score of 3 or 4. Patients either received dupilumab 300mg SC once a week, dupilumab 300mg SC every two weeks, or placebo, all in combination with TCS. The primary efficacy endpoint was the percent of patients who achieved IGA 0 or 1 at 16 weeks.
Study findings showed that treatment with dupilumab with TCS significantly improved measures of overall disease severity at 16 and 52 weeks vs. placebo with TCS. At Week 16, 39% of patients treated with either dupilumab 300mg weekly or every two weeks, with TCS, achieved clearing or near-clearing of skin lesions (IGA 0 or 1) vs. 12% of placebo-treated patients with TCS (P<0.0001). EASI-75, a 75% reduction on an index measuring eczema severity, was achieved in 64% and 69% of patients treated with dupilumab 300mg weekly and every two weeks, respectively, compared to 23% of patients treated with placebo (P<0.0001). At Week 52, 40% and 36% of patients treated with dupilumab 300mg weekly and every two weeks, respectively, achieved IGA 0 or 1 vs. 12.5% of placebo-treated patients (P<0.0001). EASI-75 was achieved in 64% of patients in the dupilumab weekly group, 65% in the dupilumab every two weeks group, and 23% in the placebo group (P<0.0001).
Adverse events rates were comparable among the three treatment groups. However, patients receiving dupilumab in both groups were less likely to discontinue therapy compared to patients in the placebo group (15% vs. 33%, respectively). Detailed study results, including long-term efficacy and safety data, will be submitted for presentation at a future medical congress.
Dupilumab is an investigational, fully human monoclonal antibody that inhibits the signaling of IL-4 and IL-13 cytokines.