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)
Sunday, March 4, 2018
South Hall A2 (Convention Center)
Diamant Thaçi, MD, Thomas R.M. Bieber, MD PhD FAAAAI, Neil M.H. Graham, Gianluca Pirozzi, Bolanle Akinlade, Laurent Eckert, Abhijit Gadkari, Marius Ardeleanu
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.