[Real-world efficacy and influencing factors of stapokibart in the treatment of moderate-to-severe chronic rhinosinusitis with nasal polyps].

Objective:To evaluate the real-world efficacy and safety of stapokibart in the treatment of moderate-to-severe chronic rhinosinusitis with nasal polyps（CRSwNP） and to explore baseline predictors for quality-of-life improvement. Methods:This prospective study included 36 patients with moderate-to-severe CRSwNP who received stapokibart treatment（300 mg every 2 weeks for 16 weeks）. Observational indicators included SNOT-22 scores, total nasal Visual Analog Scale（VAS） scores, olfactory function scores, nasal polyp scores（NPS）, sinus CT Lund-Mackay scores, and peripheral blood eosinophil counts. The primary endpoints were the mean changes from baseline in the SNOT-22 score and nasal endoscopy-assessed nasal polyp score（NPS） at Week 16. Univariate random intercept mixed linear models were employed to evaluate factors influencing therapeutic response. Results:After 16 weeks of treatment, both subjective and objective indicators showed significant improvement: the mean SNOT-22 score decreased from（45.90±15.60） at baseline to（18.20±13.60）, the NPS improved by an average of（2.72±1.93） points, and the Sniffin'Sticks olfactory identification score increased by（5.36±3.84） points（all P<0.001）. Olfactory symptoms exhibited early improvement by week 2 of treatment. The univariate random intercept mixed linear model revealed that baseline variables-including age, BMI, history of surgery, allergic rhinitis, history of asthma, and peripheral blood counts-did not significantly predict the longitudinal improvement trend of the SNOT-22 score（P>0.05）. Regarding safety, injection site reactions involving swelling and pain were the most frequently reported adverse events, and no serious adverse events occurred. Conclusion:Stapokibart demonstrated significant and rapid efficacy with a favorable safety profile in real-world clinical practice for moderate-to-severe CRSwNP, showing strong applicability across different baseline patient characteristics.