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Introduction <p>In the ASPEN trial, brensocatib, a dipeptidyl peptidase 1 inhibitor, significantly reduced the burden of pulmonary exacerbations versus placebo in participants with bronchiectasis. A prespecified subgroup analysis evaluated the efficacy and safety of brensocatib in participants of Asian race with bronchiectasis from ASPEN.</p> Methods <p>Participants with confirmed bronchiectasis and a history of exacerbations in the 12&#xa0;months before screening [adults (18–85&#xa0;years), ≥ 2; adolescents (12– &lt; 18&#xa0;years), ≥ 1] received once-daily brensocatib (10 or 25&#xa0;mg) or matching placebo for 52&#xa0;weeks (adults, 1:1:1; adolescents, 2:2:1). Efficacy endpoints included annualized exacerbation rate, time to first exacerbation, and change at 52&#xa0;weeks in post-bronchodilator (BD) forced expiratory volume (FEV) in 1&#xa0;s (post-BD FEV<sub>1</sub>) and Quality of Life–Bronchiectasis Respiratory Symptom Score (QOL-B RSS). Safety was monitored from enrollment through the end of study.</p> Results <p>Overall, 191 participants were of Asian race (<i>n</i> = 63, brensocatib 10&#xa0;mg; <i>n</i> = 64, brensocatib 25&#xa0;mg; <i>n</i> = 64, placebo). Brensocatib 10&#xa0;mg and brensocatib 25&#xa0;mg significantly reduced the annualized exacerbation risk (both by ~ 60%; <i>p</i> = 0.0005 and <i>p</i> = 0.0012, respectively) and prolonged the time to first exacerbation (hazard reduced by ~ 55%; <i>p</i> = 0.0039 and 0.0082, respectively) versus placebo. Brensocatib 25&#xa0;mg significantly reduced post-BD FEV<sub>1</sub> decline [least squares mean difference (95% CI): 69 (24–114) mL, <i>p</i> = 0.0029] and improved QOL-B RSS score [7.49 (2.48–12.50) points, <i>p</i> = 0.0034] versus placebo. The frequency of treatment-emergent adverse events was similar across treatment groups and consistent with the overall ASPEN results.</p> Conclusions <p>In participants of Asian race, brensocatib 10&#xa0;mg and 25&#xa0;mg reduced the burden of pulmonary exacerbations, and the 25-mg dose reduced lung function decline and improved patient-reported symptoms versus placebo. The efficacy and safety of brensocatib in participants of Asian race were largely consistent with the overall ASPEN population, with select outcomes showing numerically greater benefit, although ASPEN was not powered to detect treatment differences in prespecified subgroup analyses.</p> ClinicalTrials.gov identifier <p>NCT04594369.</p>

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Efficacy and Safety of Brensocatib in Participants of Asian Race with Non-cystic Fibrosis Bronchiectasis: A Subgroup Analysis of the ASPEN Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月16日

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  • Doreen Addrizzo-Harris,
  • James D. Chalmers,
  • Stefano Aliberti,
  • Pierre-Régis Burgel,
  • Brian M. Morrissey,
  • Xiangmin Zhang,
  • Chunpeng Fan,
  • Melanie Lauterio,
  • Sebastian Fucile,
  • Dianne Griffis,
  • Ariel Teper

摘要

Introduction

In the ASPEN trial, brensocatib, a dipeptidyl peptidase 1 inhibitor, significantly reduced the burden of pulmonary exacerbations versus placebo in participants with bronchiectasis. A prespecified subgroup analysis evaluated the efficacy and safety of brensocatib in participants of Asian race with bronchiectasis from ASPEN.

Methods

Participants with confirmed bronchiectasis and a history of exacerbations in the 12 months before screening [adults (18–85 years), ≥ 2; adolescents (12– < 18 years), ≥ 1] received once-daily brensocatib (10 or 25 mg) or matching placebo for 52 weeks (adults, 1:1:1; adolescents, 2:2:1). Efficacy endpoints included annualized exacerbation rate, time to first exacerbation, and change at 52 weeks in post-bronchodilator (BD) forced expiratory volume (FEV) in 1 s (post-BD FEV1) and Quality of Life–Bronchiectasis Respiratory Symptom Score (QOL-B RSS). Safety was monitored from enrollment through the end of study.

Results

Overall, 191 participants were of Asian race (n = 63, brensocatib 10 mg; n = 64, brensocatib 25 mg; n = 64, placebo). Brensocatib 10 mg and brensocatib 25 mg significantly reduced the annualized exacerbation risk (both by ~ 60%; p = 0.0005 and p = 0.0012, respectively) and prolonged the time to first exacerbation (hazard reduced by ~ 55%; p = 0.0039 and 0.0082, respectively) versus placebo. Brensocatib 25 mg significantly reduced post-BD FEV1 decline [least squares mean difference (95% CI): 69 (24–114) mL, p = 0.0029] and improved QOL-B RSS score [7.49 (2.48–12.50) points, p = 0.0034] versus placebo. The frequency of treatment-emergent adverse events was similar across treatment groups and consistent with the overall ASPEN results.

Conclusions

In participants of Asian race, brensocatib 10 mg and 25 mg reduced the burden of pulmonary exacerbations, and the 25-mg dose reduced lung function decline and improved patient-reported symptoms versus placebo. The efficacy and safety of brensocatib in participants of Asian race were largely consistent with the overall ASPEN population, with select outcomes showing numerically greater benefit, although ASPEN was not powered to detect treatment differences in prespecified subgroup analyses.

ClinicalTrials.gov identifier

NCT04594369.