The Journal of allergy and clinical immunology · 2026
Efficacy of Dupilumab for Patients with Chronic Rhinosinusitis without Nasal Polyps: a Randomized Double-Blind Placebo Controlled Phase II Study.
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Tversky Jody, Lane Andrew P, Schroeder John, Ozeryanskiy Joseph, Hansen Christopher, Kim Jean, Azar Antoine, Nash Scott, Corbett Mark, Radwan Amr, Rowan Nicholas R
Аннотация
BACKGROUND: Chronic rhinosinusitis without nasal polyps (CRSsNP) is a heterogeneous inflammatory disease affecting up to 8% of the population. No biologic therapies are currently approved for CRSsNP, and emerging data suggest that T2-high endotypes may respond preferentially to targeted therapy.
OBJECTIVE: To evaluate the efficacy and safety of dupilumab, a monoclonal antibody targeting the interleukin-4/interleukin-13 signaling pathway, in patients with moderate-severe CRSsNP and to explore differential responses by T2-inflammatory endotype.
METHODS: In a 6-month, randomized, double-blind, placebo-controlled trial, 33 adults with moderate-severe CRSsNP received dupilumab 300 mg or placebo every 2 weeks. Primary outcomes were change in 22-item Sino-Nasal Outcome Test (SNOT-22) and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) scores. Secondary outcomes included CT sinus scores and use of rescue medications. Prespecified subgroup analyses were performed in T2-high patients, defined by pronounced allergen skin test positivity or elevated blood eosinophils.
RESULTS: Dupilumab significantly improved SNOT-22 (-7.0 vs placebo; P<.001) and mini-RQLQ (-5.2 vs placebo; P<.01) scores. T2-high patients showed numerically greater improvement in SNOT-22 (-11.3; P=.07) and significant improvement in mini-RQLQ (-9.2; P<.01). Reductions in CT scores and rescue medication use favored dupilumab but were not statistically significant. Treatment was well tolerated, and all participants completed the study.
CONCLUSION: Dupilumab was associated with meaningful improvements in patient-reported outcomes in adults with CRSsNP. The observed trend toward enhanced benefit in T2-high patients supports the potential for endotype-directed therapy and underscores the need for larger studies to evaluate the role of T2-targeted biologics in CRSsNP management.
OBJECTIVE: To evaluate the efficacy and safety of dupilumab, a monoclonal antibody targeting the interleukin-4/interleukin-13 signaling pathway, in patients with moderate-severe CRSsNP and to explore differential responses by T2-inflammatory endotype.
METHODS: In a 6-month, randomized, double-blind, placebo-controlled trial, 33 adults with moderate-severe CRSsNP received dupilumab 300 mg or placebo every 2 weeks. Primary outcomes were change in 22-item Sino-Nasal Outcome Test (SNOT-22) and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) scores. Secondary outcomes included CT sinus scores and use of rescue medications. Prespecified subgroup analyses were performed in T2-high patients, defined by pronounced allergen skin test positivity or elevated blood eosinophils.
RESULTS: Dupilumab significantly improved SNOT-22 (-7.0 vs placebo; P<.001) and mini-RQLQ (-5.2 vs placebo; P<.01) scores. T2-high patients showed numerically greater improvement in SNOT-22 (-11.3; P=.07) and significant improvement in mini-RQLQ (-9.2; P<.01). Reductions in CT scores and rescue medication use favored dupilumab but were not statistically significant. Treatment was well tolerated, and all participants completed the study.
CONCLUSION: Dupilumab was associated with meaningful improvements in patient-reported outcomes in adults with CRSsNP. The observed trend toward enhanced benefit in T2-high patients supports the potential for endotype-directed therapy and underscores the need for larger studies to evaluate the role of T2-targeted biologics in CRSsNP management.