The Journal of allergy and clinical immunology · 2026
Dupilumab for patients with allergic fungal rhinosinusitis.
СтатьяНазвание и аннотация: Перевод в очереди
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Luong Amber U, Levy Joshua M, Wise Sarah K, Han Joseph K, Yoshikawa Mamoru, Zhang Luo, Schlosser Rodney, Ranganathan Prerna, Dakin Paula, Maloney Jennifer, Yancopoulos George D, Fontenot Andrew P, Phadke Neelam A, Robinson Lacey R
Аннотация
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 mAb blocking IL-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 age ≥6 years were randomized to dupilumab or matched placebo for 52 weeks. The primary end point was Lund-Mackay computed tomography score, quantifying sinus opacification, at 52 weeks. Secondary end points were multiplicity-controlled and hierarchically tested.
RESULTS: At week 52, the dupilumab group's (n = 33) Lund-Mackay computed tomography scores improved versus those of the placebo group (n = 29) (least squares mean difference [LSMD]: -7.36 [95% CI: -9.38 to -5.35]; P < .001). At week 24, dupilumab improved nasal congestion score (LSMD: -0.87 [95% CI: -1.18 to -0.56]), total symptom score (LSMD: -2.18 [95% CI: -3.04 to -1.32]), and nasal polyp score (LSMD: -2.36 [95% CI: -3.31 to -1.41]) versus placebo, and further decreased nasal polyp score to -2.77 (95% CI: -3.82 to -1.72) (all P < .001) at week 52. Dupilumab lowered the risk of receiving systemic corticosteroids and/or undergoing sinonasal surgery versus 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 versus placebo demonstrated significant improvement in radiographic, endoscopic, clinical, and quality-of-life outcomes, and need for systemic corticosteroids and/or surgery. Dupilumab was well tolerated. (LIBERTY AFRS AIMS, NCT04684524).
OBJECTIVE: We sought to understand the effect of dupilumab in AFRS.
METHODS: In this phase 3 trial, patients with AFRS age ≥6 years were randomized to dupilumab or matched placebo for 52 weeks. The primary end point was Lund-Mackay computed tomography score, quantifying sinus opacification, at 52 weeks. Secondary end points were multiplicity-controlled and hierarchically tested.
RESULTS: At week 52, the dupilumab group's (n = 33) Lund-Mackay computed tomography scores improved versus those of the placebo group (n = 29) (least squares mean difference [LSMD]: -7.36 [95% CI: -9.38 to -5.35]; P < .001). At week 24, dupilumab improved nasal congestion score (LSMD: -0.87 [95% CI: -1.18 to -0.56]), total symptom score (LSMD: -2.18 [95% CI: -3.04 to -1.32]), and nasal polyp score (LSMD: -2.36 [95% CI: -3.31 to -1.41]) versus placebo, and further decreased nasal polyp score to -2.77 (95% CI: -3.82 to -1.72) (all P < .001) at week 52. Dupilumab lowered the risk of receiving systemic corticosteroids and/or undergoing sinonasal surgery versus 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 versus placebo demonstrated significant improvement in radiographic, endoscopic, clinical, and quality-of-life outcomes, and need for systemic corticosteroids and/or surgery. Dupilumab was well tolerated. (LIBERTY AFRS AIMS, NCT04684524).