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Efficacy of benralizumab in reducing cough and/or dyspnea frequency, and improving cough-specific health-related quality of life in patients with severe eosinophilic asthma in Asia

Journal
Therapeutic advances in respiratory disease (Q1)
Published
27 August 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Kefang Lai, Dejun Sun, Ranran Dai, Xingxiang Xu, Jianping Zhao, Tong Wu, et al.
PMID
42661269
DOI
10.1177/17534666261471304

Why clinicians should know about it

Abstract

BACKGROUND: Biologics' efficacy in relieving cough and dyspnea in severe eosinophilic asthma (SEA) is under-characterized. OBJECTIVES: This exploratory analysis evaluated the efficacy of benralizumab separately in reducing cough and/or dyspnea in patients with SEA. DESIGN: Post-hoc analysis of a phase III, randomized, double-blind, placebo-controlled trial. METHODS: MIRACLE (NCT03186209) data were used, involving patients aged 12-75 years with uncontrolled SEA. Patients reporting baseline frequent cough and/or dyspnea based on St George's Respiratory Questionnaire (SGRQ) items were analyzed. Changes in cough frequency, cough-specific HRQoL, and dyspnea frequency measured through relevant SGRQ items were evaluated over 48 weeks. Subgroup analyses based on baseline blood eosinophil counts (bEOS ⩾300 cells/μL) were conducted. RESULTS: A total of 383 patients (benralizumab: 189; placebo: 194) with baseline frequent cough and 304 with baseline frequent dyspnea (benralizumab: 151; placebo: 153) were included. The proportions of patients transitioning to non-frequent cough with benralizumab versus placebo were 54.0% versus 39.7% at Week 8 (p = 0.0051), and 59.3% versus 56.7% at Week 48. Improvements in cough-related SGRQ items, including reductions in cough-related pain/fatigue, less sleep disturbance, and decreased embarrassment in public, occurred earlier with benralizumab compared to placebo and were sustained through Week 48. Among patients with higher inflammatory burden (baseline bEOS ⩾300 cells/μL), the prevalence of frequent cough at baseline was higher. In this subgroup, a higher proportion transitioned to non-frequent cough with benralizumab versus placebo at both Week 8 (55.3% vs 37.1%; p = 0.0027) and Week 48 (59.8% vs 52.1%). Differential improvements in cough-related SGRQ items favoring benralizumab were consistently observed. Reductions in dyspnea frequency followed a similar pattern, with benralizumab showing greater improvements versus placebo at both Week 8 (64.2% vs 47.1%; p = 0.0026) and Week 48 (75.5% vs 63.4%; p = 0.0221). CONCLUSION: Benralizumab showed potential to rapidly reduce cough and/or dyspnea frequency, and to improve cough-specific HRQoL more quickly than placebo in patients with SEA, with sustained advantage in cough-related SGRQ items through Week 48. Improvements were pronounced in patients with higher baseline bEOS, potentially reflecting a higher disease burden. However, as this was an exploratory analysis, further validation using cough-specific clinical endpoints is warranted. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03186209, https://clinicaltrials.gov/study/NCT03186209.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.