[A prospective real-world study of stapokibart in the treatment of moderate to severe seasonal allergic rhinitis].

Objective

To evaluate the real-world efficacy and safety of stapokibart（CM310） in Chinese patients with moderate-to-severe seasonal allergic rhinitis（SAR）, and the impact of baseline blood eosinophil（EOS） levels on therapeutic outcomes.

Methods

A prospective observational study was conducted, enrolling 31 SAR patients diagnosed at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, from March to May 2025. Patients received subcutaneous injections of stapokibart: 2 initial doses（300 mg each）, followed by a booster dose（300 mg） 2 weeks later, with a 4-week follow-up. The primary endpoint was the mean change in Total Nasal Symptom Score（TNSS） from baseline to Week 4. Secondary endpoints included changes in Total Ocular Symptom Score（TOSS）, total nasal Visual Analogue Scale（VAS） score, concomitant medication use, and safety outcomes. Subgroup analysis was performed based on baseline blood EOS counts.

Results

After 4 weeks of treatment, the mean TNSS decreased from（8.16±2.67） at baseline to （3.00±1.64）（P<0.001）, with the most significant improvements in nasal congestion and rhinorrhea. The mean TOSS reduced from（4.87±3.14） to （1.37±1.48）（P<0.001）, and the mean VAS score declined from（7.66±2.13） to （3.49±1.88）. Subgroup analysis showed that the high EOS subgroup（≥300/μL） had significantly better relief of nasal congestion（P<0.001） and nasal itching（P=0.002） compared with the low EOS subgroup. Regarding medication use, the proportion of patients not using any symptomatic medications increased from 12.0% to 43.3%, and the use of oral corticosteroids decreased to 0. No serious adverse events occurred during the study.

Conclusion

Stapokibart is safe and effective in treating Chinese SAR patients, providing significant improvements in nasal and ocular symptoms and reducing medication dependence. A baseline blood EOS count of ≥300/μL is an important predictive factor for favorable nasal symptom outcomes.