Dupilumab in Moderate-to-Severe Atopic Dermatitis With or Without Comorbid Allergic Rhinitis: Pooled Analysis of 2 Randomized Phase 3 Trials (LIBERTY AD SOLO 1 & 2)

RATIONALE: Dupilumab, a fully human anti-IL-4Rα mAb, inhibits signaling of IL-4 and IL-13, key drivers of type 2/Th2 immune diseases. Dupilumab is approved by the FDA with or without topical corticosteroids for treatment of adults with moderate-to-severe AD. We report on efficacy and safety of dupilumab in adults with moderate-to-severe AD with or without patient-reported comorbid allergic rhinitis (AR) in two pooled phase 3 monotherapy trials (LIBERTY AD SOLO 1&2: NCT02277743; NCT02277769).

METHODS: Patients were randomized (1:1:1) to subcutaneous dupilumab 300mg every 2 weeks (q2w; n=457) or weekly (qw; n=462), or placebo (n=460) for 16 weeks. Endpoints included proportion of patients with Investigator’s Global Assessment (IGA) 0/1, ≥75% improvement in Eczema Area and Severity Index (EASI-75), and peak pruritus Numerical Rating Scale improvement ≥4 (NRS ≥4). Safety was assessed.

RESULTS: Baseline characteristics were consistent across groups and between patients with (dupilumab q2w, n=224/qw, n=244, placebo, n=224) or without comorbid AR. At Week 16, more patients with comorbid AR receiving dupilumab 300mg q2w/qw achieved IGA 0/1 (32.6%/36.1% vs 9.4%), EASI-75 (45.5%/48.0% vs 12.5%), and NRS ≥4 (39.2%/35.9% vs 10.8%) versus placebo (p<0.0001 for all). Patients without comorbid AR showed similar results. Treatment groups (dupilumab q2w/qw, placebo) had similar rates of adverse events (69%/67%, 69%). Injection-site reactions and conjunctivitis were more frequent in dupilumab-treated patients.

CONCLUSIONS: This subgroup analysis shows that dupilumab-treated patients with or without comorbid AR have comparable/significant improvement in AD signs and symptoms. Future studies in AD patients with symptomatic comorbid AR will help assess the potential benefit of dupilumab in both conditions.