[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.