Dupilumab efficacy and safety in patients with allergic bronchopulmonary aspergillosis.
Arnaud Bourdin, Jonathan Corren, Anand Shah et al.
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In 30 seconds
This double-blind phase 2 randomised trial evaluated dupilumab versus placebo in patients aged 12 years or older with asthma and allergic bronchopulmonary aspergillosis (ABPA). At week 24, prebronchodilator FEV1 improved significantly more with dupilumab: least squares mean change, 0.203 L vs 0.002 L; treatment difference, 0.201 L (95% CI, 0.08-0.33; P = .002). Severe respiratory exacerbations were numerically less frequent, and more baseline systemic corticosteroid users stopped corticosteroids with dupilumab. Overall safety was consistent with the established dupilumab profile.
Key findings
- At week 24, FEV1 treatment difference was 0.201 L (95% CI, 0.08-0.33; P = .002) in favour of dupilumab.
- Adjusted annualized severe respiratory exacerbation rates were 0.695 with dupilumab and 1.551 with placebo, a 55.2% reduction (nominal P = .0627).
- Among baseline systemic corticosteroid users, 71.4% receiving dupilumab and 14.3% receiving placebo no longer required corticosteroids at week 24.
- Overall safety was consistent with the known dupilumab safety profile.
Why it matters
ABPA can worsen asthma, and the abstract notes that no targeted therapies are approved. The trial provides controlled evidence that blocking IL-4 and IL-13 can improve lung function in this population, while also reporting outcomes relevant to exacerbations and systemic corticosteroid use. The exacerbation result was numerical and should be interpreted with its nominal P value.
What to keep in mind
This was a phase 2 trial with 62 participants; follow-up varied from 24 to 52 weeks. The exacerbation reduction had a nominal P value of .0627.