司普奇拜单抗治疗季节性过敏性鼻炎的累计效应研究OA

OBJECTIVE To explore the pattern of nasal and ocular symptom relief and the cumulative symptom relief rate in patients with seasonal allergic rhinitis(SAR)treated with Stapokibart,and provide exploratory evidence-based support for individualized targeted treatment.METHODS A post-hoc exploratory analysis was performed based on the dataset of a multicenter,randomized,double-blind,placebo-controlled phase Ⅲ clinical trial(PHECD).A total of 108 patients with SAR were enrolled,including 50 patients in the Stapokibart group and 58 patients in the placebo group.The cumulative relief percentage of patients with mild or absent nasal and ocular symptoms,as well as the response rate of patients with an improvement of≥1 point from baseline in each individual nasal and ocular symptom,were set as evaluation endpoints.The chi-square test was adopted for intergroup comparisons.RESULTS The cumulative relief percentage of nasal symptoms in the Stapokibart group was significantly higher than that in the placebo group starting from Day 7(34.0%vs.13.8%,P=0.021),reaching 84.0%at Day 28,which was markedly higher than 53.4%in the placebo group(P<0.001).The statistically significant superiority in cumulative relief of ocular symptoms emerged at Day 23,with a relief rate of 94.0%at Day 28 versus 74.1%in the placebo group(P<0.001).Analysis of individual symptoms demonstrated that Stapokibart exerted an early and sustained superior effect on nasal congestion and rhinorrhea throughout the treatment period(P<0.05),and significant long-term improvement was observed for ocular redness(P=0.005).No intergroup differences were found in sneezing,nasal pruritus,lacrimation and ocular pruritus(P>0.05).CONCLUSION Findings from this post-hoc analysis indicated that Stapokibart presents an obvious time-dependent cumulative efficacy in alleviating nasal and ocular symptoms of SAR,with an earlier onset of therapeutic effect on nasal symptoms.It achieves prominent efficacy against persistent nasal congestion,rhinorrhea and ocular redness mediated by IL-4/IL-13,while showing limited improvement in histamine-dominated immediate hypersensitivity symptoms.This preliminary result may provide clues for stratified targeted therapy of moderate-to-severe SAR,and prospective pre-specified endpoint trials are required to validate the conclusions.