Dupilumab for Patients with Allergic Fungal Rhinosinusitis

Authors

• Amber U. Luong, McGovern Medical School, a part of UTHealth Houston
• Joshua M. Levy, Emory University School of Medicine
• Sarah K. Wise, Emory University School of Medicine
• Joseph K. Han, Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityFollow
• Mamoru Yoshikawa, Toho University Ohashi Medical Center
• Luo Zhang, Beijing TongRen Hospital, Capital Medical University, Beijing, China
• Rodney Schlosser, Medical University of South Carolina
• Prerna Ranganathan, Sanofi, Morristown, NJ
• Paula Dakin, Regeneron Pharmaceuticals Inc.
• Jennifer Maloney, Regeneron Pharmaceuticals Inc.
• George D. Yancopoulos, Regeneron Pharmaceuticals Inc.
• Andrew P. Fontenot, Regeneron Pharmaceuticals Inc.
• Neelam A. Phadke, Sanofi, Cambridge, Mass
• Lacey R. Robinson, Sanofi, Cambridge, Mass

Document Type

Article

Publication Date

2026

DOI

10.1016/j.jaci.2026.07.006

Publication Title

Journal of Allergy and Clinical Immunology

Volume

Advance online publication

Pages

1-10

Abstract

Background

Allergic fungal rhinosinusitis (AFRS) is a severe subtype of chronic rhinosinusitis characterized by fungal hypersensitivity and accentuated type 2 inflammation. Dupilumab-a fully human monoclonal antibody blocking interleukin-4/13, approved for type 2 inflammatory diseases, including chronic rhinosinusitis with nasal polyps-may benefit patients with AFRS.

Objective

We sought to understand the effect of dupilumab in AFRS

Methods

In this phase 3 trial, patients with AFRS aged ≥6 years were randomized to dupilumab or matched placebo for 52 weeks. The primary end point was Lund-Mackay computed tomography (LMK-CT) score, quantifying sinus opacification, at 52 weeks. Secondary end points were multiplicity-controlled and hierarchically tested.

Results

At week 52, dupilumab (N=33) improved LMK-CT scores vs placebo (N=29) (LSMD -7.36 [95% CI, -9.38 to -5.35]; P< .001). At week 24, dupilumab improved nasal congestion score (-0.87 [-1.18 to -0.56]), total symptom score (-2.18 [-3.04 to -1.32]), and nasal polyp score (NPS; -2.36 [-3.31 to -1.41]) vs placebo, and further decreased NPS to -2.77 (-3.82 to -1.72) (all P< .001) at week 52. Dupilumab lowered the risk of receiving systemic corticosteroids and/or undergoing sinonasal surgery vs placebo by 92% (risk difference -29.1% [95% CI, -46.42 to -11.79]; P=.0010). In patients with comorbid asthma, dupilumab also benefited asthma measures. The proportion of patients having treatment-emergent adverse events was similar between dupilumab and placebo (69.7% and 78.6%).

Conclusions

In patients with AFRS, dupilumab vs placebo demonstrated significant improvement in radiographic, endoscopic, clinical, quality-of-life outcomes, and need for systemic corticosteroids and/or surgery. Dupilumab was well tolerated.

Rights

© 2026 The Authors.

This is an open access article under the Creative Commons Attribution 4.0 International (CC BY 4.0) License. 

Original Publication Citation

Luong, A. U., Levy, J. M., Wise, S. K., Han, J. K., Yoshikawa, M., Zhang, L., Schlosser, R., Ranganathan, P., Dakin, P., Maloney, J., Yancopoulos, G. D., Fontenot, A. P., Phadke, N. A., & Robinson, L. R. (2026). Dupilumab for patients with allergic fungal rhinosinusitis. Journal of Allergy and Clinical Immunology. Advance online publication. https://doi.org/10.1016/j.jaci.2026.07.006

Repository Citation

Luong, A. U., Levy, J. M., Wise, S. K., Han, J. K., Yoshikawa, M., Zhang, L., Schlosser, R., Ranganathan, P., Dakin, P., Maloney, J., Yancopoulos, G. D., Fontenot, A. P., Phadke, N. A., & Robinson, L. R. (2026). Dupilumab for patients with allergic fungal rhinosinusitis. Journal of Allergy and Clinical Immunology. Advance online publication. https://doi.org/10.1016/j.jaci.2026.07.006