Adults with moderate to severe atopic dermatitis (AD) with comorbid asthma experience the same improvement in AD signs and symptoms with dupilumab treatment as those without asthma, according to pooled data from two large phase 3 clinical trials.
At week 16 in the pooled analysis of the 2 placebo-controlled trials, more patients with comorbid asthma who were randomized to dupilumab achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear), a >75% improvement in Eczema Area and Severity Index (EASI-75), and an improvement >4 on the peak pruritus Numerical Rating Scale (NRS). These data were presented by Mette Deleuran, Aarhus University Hospital, Aarhus, Denmark, at the 2018 American Academy of Dermatology annual meeting in San Diego.
Dupilumab is approved by the U.S. Food and Drug Administration with or without topical corticosteroids for the treatment of adults with moderate-to-severe AD.
Both phase 3 studies included in the pooled analysis—LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2—were trials of dupilumab monotherapy in patients with or without comorbid self-reported asthma. They had identical designs. Patients were randomly assigned in a 1:1:1 ratio to receive 16 weeks of subcutaneous dupilumab, 300 mg, or placebo weekly or the same dose of dupilumab every other week alternating with placebo.
The primary outcome in SOLO 1, the proportion of patients who had an IGA score of 0 or 1 at week 16, was achieved by 38% of the duplumab every-other-week group and 37% who received dupilumab weekly versus 10% of the placebo group (P<0.001 for both comparisons). The results were similar in SOLO 2, with the primary outcome occurring in 36% who received dupilumab every other week and 36% who received it weekly, compared with 8% of the placebo recipients (P<0.001 for both comparisons).
In the cohorts with asthma:
34.1% randomized to dupilumab every other week and 31.9% randomized to weekly dupilumab achieved an IGA of 0 or 1, compared with 9.3% of the placebo arm (P<0.001 for both comparisons);
50.0% randomized to dupilumab every other week and 47.4% randomized to weekly dupilumab achieved an EASI-75 improvement >75%, compared with 13.7% of placebo recipients (P<0.001 for both comparisons);
37.9% randomized to dupilumab every other week and 37.8% randomized to weekly dupilumab achieved a peak pruritus NRS improvement >4, compared with 9.3% of the placebo group (P<0.001 for both comparisons).
Deleuran M, Guttman-Yassky E, Kingo K, et al. Dupilumab in moderate-to-severe atopic dermatitis with or without comorbid asthma: Pooled analysis of 2 randomized phase 3 trials (LIBERTY AD SOLO 1 & 2). Presented at the 2018 American Academy of Dermatology Annual Meeting, February 16-20, 2018; San Diego, Calif. Abstract 417.