Efficacy of Dupilumab for Patients with Chronic Rhinosinusitis without Nasal Polyps: a Randomized Double-Blind Placebo Controlled Phase II Study
In brief
Dupilumab improved sinonasal symptom scores by 7 points versus placebo
In a six-month trial of 33 adults with chronic sinusitis without nasal polyps, dupilumab improved a 22-item symptom score by 7 points and a quality-of-life score by 5.2 points compared with placebo. Patients with signs of type 2 inflammation appeared to benefit more, but the subgroup was small, and larger trials are needed to confirm who benefits and whether imaging or rescue medication use improves.
- Journal
- The Journal of allergy and clinical immunology (Q1)
- Published
- 9 October 2026
- Study design
- Phase 2 randomized trial (exploratory)
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Jody Tversky, Andrew P Lane, John Schroeder, Joseph Ozeryanskiy, Christopher Hansen, Jean Kim, et al.
- PMID
- 42854988
- DOI
- 10.1016/j.jaci.2026.08.032
Why clinicians should know about it
- Picked for Otorhinolaryngology (paper of the day, 14 October 2026): Dupilumab phase II RCT in CRSsNP
Abstract
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.