Tezepelumab in Chinese Patients With Severe Chronic Rhinosinusitis With Nasal Polyps: A Prespecified Subgroup Analysis of the Phase 3 WAYPOINT Trial

Background Chronic rhinosinusitis with nasal polyps (CRSwNP) in Chinese patients often exhibits a mixed Type 1/2/3 inflammatory phenotype (63%), potentially impacting the efficacy of biologics targeting Type 2 inflammation. This prespecified subgroup analysis of WAYPOINT (NCT04851964) evaluated the efficacy and safety of tezepelumab in Chinese patients with CRSwNP. Methods Adult patients with severe CRSwNP were randomized 1:1 to tezepelumab (210 mg) or placebo for 52 weeks. Co‐primary endpoints were changes from baseline at Week 52 (W52) in total nasal‐polyp score and bi‐weekly mean nasal‐congestion score. Key secondary endpoints included changes from baseline in Nasal Polyposis Symptom Diary (NPSD) loss‐of‐smell score, 22‐item Sinonasal Outcome Test (SNOT‐22) total score, Lund–Mackay score, NPSD total symptom score, and time to first nasal‐polyp surgery decision and/or systemic glucocorticoid use. Results Twenty‐nine patients received tezepelumab, and 34 received placebo. At W52, tezepelumab achieved numerically greater improvements in total nasal‐polyp score (least‐squares mean difference vs. placebo [95% CI]: −2.03 [−2.88, −1.19]) and bi‐weekly mean nasal‐congestion score (−0.72 [−1.23, −0.21]). Compared with placebo, tezepelumab also improved NPSD loss‐of‐smell score (−0.44 [−0.82, −0.06]), SNOT‐22 total score (−16.34 [−29.80, −2.88]), Lund–Mackay score (−5.30 [−7.23, −3.38]), and NPSD total symptom score (−3.76 [−6.89, −0.63]). No tezepelumab‐treated patients required nasal‐polyp surgery or systemic glucocorticoids. Conclusion Consistent with the overall population, tezepelumab reduced nasal‐polyp size and improved loss‐of‐smell and other sinonasal symptoms in Chinese patients with CRSwNP, with a favorable safety profile. No surgery or systemic glucocorticoids were required. These benefits were observed despite relatively lower baseline eosinophil counts in these patients. Further investigation is warranted to assess the generalizability to the broader Chinese population with CRSwNP.