Phase 3 RCT (LIBERTY AFRS AIMS) evaluating dupilumab vs. matched placebo over 52 weeks in patients aged ≥6 years with allergic fungal rhinosinusitis (AFRS), a severe type 2 inflammatory subtype of chronic rhinosinusitis.
Dupilumab (n=33) significantly reduced sinus opacification vs. placebo (n=29) at 52 weeks (LMK-CT LSMD −7.36; 95% CI −9.38 to −5.35; P<.001) and cut the risk of systemic corticosteroids and/or sinonasal surgery by 92% (risk difference −29.1%; P=.001). Nasal polyp scores, nasal congestion, and total symptom scores all improved significantly by week 24 and continued to improve at week 52. Adverse event rates were similar between groups (69.7% dupilumab vs. 78.6% placebo).
Very small sample size (N=62 total) limits statistical power and generalizability. The trial duration of 52 weeks does not address long-term outcomes or recurrence after stopping treatment. Imbalance in group sizes (33 vs. 29) warrants attention in interpreting effect estimates.
For patients with AFRS—especially those at high risk of repeat surgery or steroid exposure—dupilumab offers significant radiographic, symptomatic, and clinical benefit with a favorable safety profile. Consider dupilumab as a disease-modifying option, particularly in those with comorbid asthma.
