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 China 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 FEV 1 , asthma control questionnaire-5 (ACQ-5) score and rate of clinical remission. Results At Week 52, in medium-dose ICS subgroup, mepolizumab (n=115) versus placebo (n=104) significantly reduced the rate of CSEs (0.53 versus 1.30 events/year; rate ratio [95% CI], 0.41 [0.25–0.66]; p<0.001), with a lower probability of CSE (Kaplan-Meier estimate, 27.0% versus 49.3%; HR [95% CI], 0.47 [0.30–0.73]; p<0.001), greater improvements, as measured by difference (95% CI) in least-square mean, in SGRQ score (−5.58 [−10.73, −0.44]), FEV 1 (119.06 mL [6.66, 231.45]) and ACQ-5 score (−0.25 [−0.46, −0.04]), and a higher proportion of patients achieving 3- or 4-component clinical remission (31.3–57.4% versus 13.5–36.5%). The rate of clinical remission was higher in ...