Document Type

Article

Publication Date

2026

DOI

10.1016/j.anai.2026.07.014

Publication Title

Annals of Allergy, Asthma & Immunology

Volume

Advance online publication

Pages

1-9

Abstract

Background

The phase 3 WAYPOINT study (NCT04851964) reported that tezepelumab improved outcomes in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), including nasal polyp size, nasal congestion, and sinonasal symptoms, and reduced the need for surgery and systemic corticosteroids (SCS).

Objective

To evaluate the efficacy and safety of tezepelumab across Japanese Epidemiological Survey of Refractory Eosinophilic Chronic Rhinosinusitis-defined eosinophilic chronic rhinosinusitis (ECRS) subgroups.

Methods

Adults with severe CRSwNP were randomized to tezepelumab 210 mg or placebo every 4 weeks. Coprimary end points were the change from baseline to week 52 in total Nasal Polyp Score and the biweekly mean Nasal Congestion Score. Secondary end points included loss of smell score, SinoNasal Outcome Test 22-item total score, Lund-Mackay total score, Nasal Polyposis Symptom Diary total symptom score, and surgery and/or SCS requirement. Safety was also assessed.

Results

Of the 408 patients, ECRS classifications were non-ECRS (11.5%), mild (18.9%), moderate (37.0%), and severe (32.6%). Compared with placebo, tezepelumab provided greater reductions from baseline to week 52 in total Nasal Polyp Score (least squares mean difference [95% CI], -1.68 [-2.27 to -1.09] and -2.25 [-2.64 to -1.87] in the non-/mild and moderate/severe subgroups, respectively; both P < .0001) and biweekly mean Nasal Congestion Score (-0.78 [-1.11 to -0.46] and -1.15 [-1.35 to -0.94], respectively; both P < .0001). Improvements in secondary end points were also greater with tezepelumab than with placebo and were consistent across subgroups. No new safety concerns were identified.

Conclusion

Tezepelumab demonstrated robust efficacy across ECRS subgroups, supporting its potential as a treatment for severe CRSwNP, regardless of eosinophilic phenotype.

Rights

© 2026 American College of Allergy, Asthma & Immunology

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

Data Availability

Article states: "Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data-sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Sub mission/Disclosure. Data for studies directly listed on Vivli can be requested through Vivli at http://www.vivli.org. Data for studies not listed on Vivli can be requested through Vivli at https://vivli.org/mem bers/enquiries-about-studies-not-listed-on-the-vivli-platform/. AstraZeneca’s Vivli member page is also available, outlining further details: https://vivli.org/ourmember/astrazeneca/."

Original Publication Citation

Fujieda, S., Otori, N., Han, J. K., Yabuta, T., Chen, C., Marchese, C., Foster, A., Ponnarambil, S. S., Chon, Y., & Lipworth, B. J. (2026). Use of tezepelumab for chronic rhinosinusitis with nasal polyps by eosinophilic endotype: WAYPOINT post-hoc analysis. Annals of Allergy, Asthma & Immunology. Advance online publication. https://doi.org/10.1016/j.anai.2026.07.014

Download

Share

COinS