This post-hoc analysis of the phase 3 WAYPOINT trial evaluated tezepelumab 210 mg SC every 4 weeks vs. placebo over 52 weeks in 408 adults with severe CRSwNP, stratified by ECRS severity subgroups (non-ECRS, mild, moderate, severe) using Japanese JESREC criteria.
Tezepelumab significantly reduced total Nasal Polyp Score vs. placebo in both non-/mild ECRS (LS mean difference −1.68, 95% CI −2.27 to −1.09) and moderate/severe ECRS (−2.25, 95% CI −2.64 to −1.87) subgroups (both P<0.0001); nasal congestion scores also improved significantly across all subgroups. No new safety signals were identified.
Post-hoc subgroup analysis limits causal inference; ECRS classification used the Japanese JESREC criteria, which may limit generalizability to non-Japanese populations; subgroup sizes (especially non-ECRS at 11.5%) were small.
Tezepelumab appears effective for severe CRSwNP regardless of eosinophilic phenotype, suggesting it can be considered even in patients who do not meet criteria for eosinophilic disease. Clinicians need not restrict its use to high-eosinophil endotypes based on these findings.
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