Add-on mepolizumab in patients with severe asthma on medium-dose inhaled corticosteroids

作者：Ruchong Chen, Liping Wei, M L Jin, Yi Jiang, Xinglin Gao, Lin Zhao, Limin Wang, Shengming Liu, Peter Howarth, Cui Xiong, Jie Huang, Peiwen Liang, Xiao Hu, N. Zhong · 发表于：ERJ Open Research · 年份：2026 · DOI：10.1183/23120541.01652-2025 · 研究领域：Asthma and respiratory diseases、Delphi Technique in Research、IL-33, ST2, and ILC Pathways

Background Mepolizumab is clinically beneficial for patients with severe asthma with an eosinophilic phenotype (SA-EP) but lacks randomised controlled trial efficacy data in those on medium-dose inhaled corticosteroids (ICS). This analysis assessed mepolizumab's efficacy in a subgroup of patients on medium-dose ICS from a Chinese phase 3 trial ( NCT03562195 ). Methods Eligible SA-EP patients had received daily ≥500 µg·day −1 fluticasone propionate or equivalent. In this post hoc evaluation, we included patients who were on baseline medium-dose ICS. Outcomes assessed were rate of clinically significant exacerbations (CSEs) at week 52, time to first CSE, St George's Respiratory Questionnaire (SGRQ) score, pre-bronchodilator forced expiratory volume in 1 s (FEV 1 ), asthma control questionnaire-5 (ACQ-5) score and rate of clinical remission. Results At week 52, in the medium-dose ICS subgroup, mepolizumab (n=115) versus placebo (n=104) significantly reduced the rate of CSEs (0.53 versus 1.30 events·yr −1 ; rate ratio 0.41 (95% CI 0.25–0.66); p<0.001), with a lower probability of CSE (Kaplan–Meier estimate, 27.0% versus 49.3%; HR 0.47 (95% CI 0.30–0.73); p<0.001), greater improvements, as measured by difference in least-square mean, in SGRQ score (−5.58, 95% CI −10.73 to −0.44), FEV 1 (119.06 mL, 95% CI 6.66–231.45) and ACQ-5 score (−0.25, 95% CI −0.46 to −0.04), and a higher proportion of patients achieving three- or four-component clinical remission (31.3–57.4% versus 13.5–36.5...