Use of CompEx in eosinophilic patients with severe, uncontrolled asthma on benralizumab

Clare Bolton, Tim Harrison, N. Lugogo, Anne Fuhlbrigge, Ian Hirsch, Thomas Bengtsson, Stefan Peterson, Martin Sidaway, Esther Garcia Gil, M. Fagerås, Carla A Da Silva
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Abstract

CompEx Asthma, a composite endpoint for asthma exacerbations, captures clinically relevant, diary-based acute worsening events (AWEs, defined as deterioration in daily peak expiratory flow concurrent with deterioration in asthma symptoms and/or rescue therapy use) and severe exacerbation events (SevEx, defined by ATS/ERS guidelines). We hypothesised that CompEx and SevEx would show similar benralizumab treatment effects and correlations to blood eosinophil counts (BECs) in patients with severe asthma.Thispost-hocanalysis of pooled 12-month data from two Phase III studies included patients aged ≥16 years with severe, uncontrolled asthma who were randomised to benralizumab 30 mg or placebo. Annualised event rates (AERs) were analysed using a negative binomial model. The impact of BEC on treatment effect was assessed.Among patients with BEC ≥300 cells/µL (n=913), benralizumab reduced AERsversusplacebo for CompEx (1.57versus2.57; risk ratio [RR] 0.61; 95% confidence interval [CI] 0.53–0.70; p<0.001), SevEx (0.94versus1.55; RR 0.60; 95% CI 0.52–0.70; p<0.001) and AWE (0.92versus1.57; RR 0.59; 95% CI 0.48–0.72; p<0.001), with greater treatment effects observed for higher BECs. In patients with BEC ≥300 cells/µL, benralizumab was associated with shorter median event duration (CompEx: 10.5versus17.0 days; SevEx: 10.0versus15.0 days; AWE: 5.0versus6.0 days).Benralizumab reduced the risk of CompEx events with treatment effects similar to those for SevEx and AWEs across a range of BECs. Use of CompEx supports the evaluation of benralizumab and other novel drugs in clinical studies.
在使用苯拉利珠单抗且病情未受控制的严重哮喘嗜酸性粒细胞患者中使用 CompEx
CompEx Asthma 是哮喘加重的一个复合终点,它捕捉与临床相关的、基于日记的急性恶化事件(AWEs,定义为每日峰值呼气流量恶化,同时哮喘症状恶化和/或使用抢救治疗)和严重加重事件(SevEx,根据 ATS/ERS 指南定义)。我们假设,在重症哮喘患者中,CompEx 和 SevEx 将显示出相似的苯拉利珠单抗治疗效果以及与血液嗜酸性粒细胞计数 (BEC) 的相关性。这项事后分析汇集了两项 III 期研究的 12 个月数据,研究对象包括年龄≥16 岁、病情未得到控制的重症哮喘患者,他们被随机分配接受苯拉利珠单抗 30 毫克或安慰剂治疗。年化事件发生率(AER)采用负二项模型进行分析。评估了BEC对治疗效果的影响。在BEC≥300个细胞/μL的患者中(n=913),苯拉利珠单抗降低了CompEx与安慰剂相比的AERs(1.57对2.57;风险比[RR] 0.61;95%置信区间[CI] 0.53-0.70;p<0.001)、SevEx(0.94versus1.55;RR 0.60;95% CI 0.52-0.70;p<0.001)和 AWE(0.92versus1.57;RR 0.59;95% CI 0.48-0.72;p<0.001),BEC 越高,治疗效果越好。在BEC≥300个细胞/μL的患者中,苯拉利珠单抗与较短的中位事件持续时间相关(CompEx:10.5天vs17.0天;SevEx:10.0天vs15.0天;AWE:5.0天vs6.0天)。苯拉利珠单抗降低了CompEx事件的风险,在一系列BEC中的治疗效果与SevEx和AWE相似。CompEx的使用支持在临床研究中对benralizumab和其他新型药物进行评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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