This double-blind phase 2 RCT evaluated dupilumab (IL-4/IL-13 blockade) vs. placebo in patients aged ≥12 years with asthma and ABPA over 24–52 weeks; 37.1% were on chronic systemic corticosteroids (SCS) at baseline (dupilumab n=35, placebo n=27).
At week 24, dupilumab significantly improved prebronchodilator FEV1 vs. placebo (LS mean change +0.203 L vs. +0.002 L; difference +0.201 L; 95% CI 0.08–0.33; P=0.002). Severe respiratory exacerbation rates were reduced by 55.2% (0.695 vs. 1.551 per person-year; nominal P=0.0627). Among SCS-dependent patients, 71.4% on dupilumab vs. 14.3% on placebo were SCS-free by week 24.
- Small sample size (n=62 total) limits power, especially for the exacerbation endpoint (nominal P=0.0627, not statistically significant). - Phase 2 trial only; larger confirmatory trials are needed before regulatory approval. - Variable treatment duration (24–52 weeks) may introduce heterogeneity in longer-term outcomes.
For patients with asthma complicated by ABPA — especially those on chronic steroids — dupilumab meaningfully improved lung function and enabled SCS discontinuation in most treated patients. Clinicians should consider dupilumab as a promising option for this difficult-to-treat population while awaiting phase 3 data and regulatory approval.
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