The Health Thread | Nepal Health News & IPAC

Abstract

Objective:To investigate the influence of different baseline clinical characteristics on the efficacy of stapokibart in patients with moderate-to-severe seasonal allergic rhinitis（SAR） and a peripheral blood eosinophil count ≥3×10⁸/L. Methods:Based on data from two randomized, double-blind, placebo-controlled trials（RCTs）, a post hoc subgroup analysis was conducted on patients with peripheral blood eosinophil counts≥3×10⁸/L who received an initial administration of 600 mg stapokibart or placebo. Efficacy endpoints were defined as the changes from baseline in the mean daily reflective total nasal symptom score（rTNSS）, mean daily reflective total ocular symptom score（rTOSS）, and Rhinoconjunctivitis Quality of Life Questionnaire（RQLQ） total score at weeks 2 and 4. An analysis of covariance（ANCOVA） model was used to calculate the least-squares mean（LSM） differences and 95% confidence intervals（CIs） between the two groups. Interaction tests were performed to evaluate the impact of various baseline characteristics（including demographic characteristics, allergen sensitization status, baseline symptom severity, etc. ） on treatment efficacy. Results:A total of 133 patients with moderate-to-severe SAR were included（61 in the stapokibart group and 72 in the placebo group）. Compared with the placebo group, the stapokibart group demonstrated significantly greater improvements from baseline in all clinical scores at weeks 2 and 4. The LSM differences for changes in mean daily rTNSS at weeks 2 and 4 were -1.3（95%CI -2.0 to -0.7; P<0.000 1） and -1.6（95%CI -2.3 to-0.8; P<0.000 1）, respectively. The LSM differences for changes in mean daily rTOSS were -0.7（95%CI -1.2 to -0.1; P=0.022 0） and -0.7（95%CI -1.3 to -0.1; P=0.020 0）, respectively. The LSM differences for changes in RQLQ scores were -0.9（95%CI -1.4 to -0.4; P=0.000 3） and -0.9（95%CI -1.4 to-0.5; P<0.000 1）, respectively. Subgroup analyses revealed that these efficacy improvement trends were generally consistent across patients with different baseline clinical characteristics, with no significant efficacy heterogeneity observed（all interaction P>0.05）. Conclusion:In moderate-to-severe SAR patients with elevated peripheral blood eosinophils, stapokibart significantly improves nasal symptoms, ocular symptoms, and quality of life. The treatment efficacy remains stable and consistent across various baseline clinical subgroups, providing evidence-based support for its broad clinical application in SAR patients. However, these findings warrant further validation in larger sample sizes. 目的：探讨不同基线临床特征对司普奇拜单克隆抗体药物治疗中重度季节性变应性鼻炎（seasonal allergic rhinitis，SAR）的疗效影响。 方法：基于2项随机、双盲、安慰剂对照（randomized controlled trial，RCT）试验数据，对外周血嗜酸性粒细胞计数≥3×10⁸/L且接受司普奇拜单抗首次注射剂量600 mg或安慰剂治疗的患者进行事后亚组分析。以治疗2周和4周平均每日回顾性鼻部总症状评分（reflective total nasal symptom score，rTNSS）、平均每日回顾性眼部总症状评分（reflective total ocular symptom score，rTOSS）和鼻结膜炎生活质量调查问卷（rhinoconjunctivitis quality of life questionnaire，RQLQ）总分较基线变化值为疗效评价指标，采用协方差分析（analysis of covariance，ANCOVA）模型计算2组间的最小二乘均数（least-squares mean，LSM）差值及其95%CI，并通过交互作用检验各基线特征（包括人口学特征、过敏原致敏状态、基线症状严重程度等）对疗效的影响。 结果：共纳入133例中重度SAR患者（司普奇拜单抗组61例，安慰剂组72例）。与安慰剂组比较，司普奇拜单抗组治疗2周和4周各项评分较基线的改善更为显著：平均每日rTNSS变化的LSM差值分别为-1.3（95%CI -2.0～-0.7；P<0.000 1）和-1.6（95%CI -2.3～-0.8；P<0.000 1）；平均每日rTOSS变化的LSM差值分别为-0.7（95%CI -1.2～-0.1；P=0.022 0）和-0.7（95%CI -1.3～-0.1；P=0.020 0）；RQLQ评分变化的LSM差值分别为-0.9（95%CI -1.4～-0.4；P=0.000 3）和-0.9（95%CI -1.4～-0.5；P<0.000 1）。亚组分析显示，上述疗效改善趋势在不同基线临床特征患者中总体一致，未见显著的疗效异质性（所有交互作用P>0.05）。 结论：在伴有外周血嗜酸性粒细胞升高的中重度SAR患者中，司普奇拜单抗可显著改善其鼻、眼症状及生活质量；且疗效在不同基线临床特征亚组中表现稳定一致，这为其在广泛SAR患者群体中的临床应用提供了循证支持。但相关结论仍需在更大样本中进一步验证。.

[Effects of baseline clinical characteristics on the efficacy of stapokibart in patients with seasonal allergic rhinitis: a post-hoc subgroup analysis].

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Abstract