Evaluating the efficacy and safety of Stapokibart (CM310) in the treatment of uncontrolled seasonal allergic rhinitis based on real-world research

PURPOSE: More than 60% of seasonal allergic rhinitis (SAR) patients still remain inadequately control even after receiving standard-of-care (SoC). Recently, Stapokibart (CM310), has demonstrated efficacy in randomized controlled trials, but real-world evidence for SoC-refractory SAR is still insufficient. METHODS: This prospective real-world study enrolled 127 patients with moderate-to-severe SAR. All participants received Stapokibart treatment (600 mg subcutaneous loading dose, followed by 300 mg at week 2). Efficacy outcomes included the reflective total nasal /ocular symptom score (rTNSS/rTOSS), visual analogue scale (VAS), and rhinoconjunctivitis quality of Life questionnaire (RQLQ) change at weeks 2 and 12. Statistical analyses used Wilcoxon signed-rank test (Bonferroni-corrected) and generalized estimating equations (GEE). RESULTS: All outcomes improved significantly at Weeks 2 and 12 vs. baseline (all P < .001). Median rTNSS decreased from 8.00 (IQR:7.00–10.00) to 4.00 (2.00–5.00) at Week 2 and remained stable; rTOSS fell to 0.00 (0.00–1.75) at Week 12. VAS and RQLQ showed progressive improvements. Only 8 (6.3%) patients reported mild, transient injection-site adverse events; no severe events occurred. CONCLUSION: Stapokibart is clinically effective and well-tolerated in SoC-refractory SAR, with sustained benefits up to 12 weeks. It is a valuable treatment for heterogeneous patients, supporting its routine clinical use.