Dupilumab for patients with allergic fungal rhinosinusitis.
Amber U Luong, Joshua M Levy, Sarah K Wise et al.
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In 30 seconds
This phase 3 randomized, placebo-controlled trial evaluated dupilumab in patients aged 6 years or older with allergic fungal rhinosinusitis over 52 weeks. At week 52, sinus opacification on computed tomography improved more with dupilumab than placebo, with a least squares mean difference in Lund-Mackay score of -7.36 (95% CI: -9.38 to -5.35; P < .001). Dupilumab also improved symptom and nasal polyp scores and reduced the risk of systemic corticosteroid use and/or sinonasal surgery versus placebo by 92%. Treatment-emergent adverse events occurred in 69.7% and 78.6%, respectively.
Key findings
- At week 52, the Lund-Mackay score difference versus placebo was -7.36 (95% CI: -9.38 to -5.35; P < .001).
- At week 24, nasal congestion, total symptom, and nasal polyp scores improved versus placebo; all reported comparisons had P < .001.
- Dupilumab lowered the risk of systemic corticosteroid use and/or sinonasal surgery versus placebo by 92% (risk difference: -29.1% [95% CI: -46.42 to -11.79]; P = .0010).
- Treatment-emergent adverse events occurred in 69.7% with dupilumab and 78.6% with placebo.
Why it matters
AFRS is a severe form of chronic rhinosinusitis, and this trial found improvements across radiographic, endoscopic, symptom, and quality-of-life outcomes with dupilumab compared with placebo. The reduction in corticosteroid use and/or surgery is clinically relevant alongside these disease measures. Similar proportions experienced treatment-emergent adverse events in the two groups, providing useful short-term comparative safety information.
What to keep in mind
The trial included 62 patients, and the reported follow-up was 52 weeks; longer-term outcomes are not provided in the abstract.