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 food allergy (FA) in two pooled phase 3 monotherapy trials (LIBERTY AD SOLO 1&2: NCT02277743; NCT02277769).
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 (NRS) improvement ≥4. Safety was assessed.
Baseline characteristics were consistent across groups and between patients with (dupilumab q2w: 39%/qw: 39%, placebo: 38%) or without patient-reported comorbid FA. At Week 16, compared to placebo more patients with comorbid FA receiving dupilumab 300mg q2w/qw achieved IGA 0/1 (29.9%/31.8% vs 8.6%), EASI-75 (40.1%/48.6% vs 12.6%), and peak pruritus NRS improvement ≥4 (34.3%/41.7% vs 10.4%) (p<0.0001 for all). Patients without comorbid FA 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.
This post-hoc subgroup analysis shows that dupilumab-treated patients with and without patient-reported comorbid FA have comparable/significant improvement in AD signs and symptoms. Further analysis testing food allergen specific IgEs are needed to corroborate these results.