[Early response to stapokibart predicts long-term efficacy in patients with chronic rhinosinusitis with nasal polyps].

Objective

To investigate whether early clinical response to stapokibart can predict long-term efficacy in patients with chronic rhinosinusitis with nasal polyps（CRSwNP）.

Methods

This post-hoc analysis was based on the CROWNS-2 study, a randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating efficacy of stapokibart for severe uncontrolled chronic rhinosinusitis with nasal polyps. Ninety patients received subcutaneous stapokibart, 300 mg, every 2 weeks for 52 weeks. Early responders were defined as those achieving a reduction of ≥1 point from baseline in both the nasal polyp score（NPS） and the nasal congestion score（NCS） at week 12. Differences in the change from baseline to week 52 in clinical outcomes（NPS, NCS, olfactory scores, TSS, SNOT-22） and laboratory biomarkers（e.g.,eosinophil counts） were compared between early responders and non-early responders.

Results

At week 12, 54%（49/90） of patients achieved early response. At baseline, early responders exhibited higher disease burden（greater NPS, NCS, blood and tissue eosinophil counts）. At week 12, early responders demonstrated significantly greater improvements in clinical evaluation compared to non-responders（P<0.05）. The significant difference in clinical evaluation between two groups persisted from week 12 through week 52. At week 52, early responders also demonstrated more significant reductions in tissue eosinophil count and eosinophil percentage.

Conclusion

Among CRSwNP patients treated with stapokibart, early responders at week 12 achieve more significant and sustained efficacy compared with non-responders. Early response may predict sustained and long-term efficacy of stapokibart, facilitating early identification of advantaged beneficiaries.