Background
In the ASPEN trial (NCT04594369), brensocatib 10 mg and 25 mg significantly reduced the burden of pulmonary exacerbations (annualized rate [primary endpoint], time to first, proportion exacerbation-free) over 52 weeks vs placebo in patients with bronchiectasis; brensocatib 25 mg significantly reduced lung function decline and nominally significantly improved patient-reported symptoms. Here we report efficacy and safety for Japanese patients.
Methods
Adults with bronchiectasis with ≥2 exacerbations in the 12 months before screening were randomized to once-daily brensocatib (10 mg or 25 mg) or placebo for 52 weeks. Endpoints included annualized exacerbation rate, time to first exacerbation, proportion remaining exacerbation-free, change from baseline in lung function, severe exacerbation rate, and change from baseline in patient-reported symptoms.
Results
Baseline characteristics of Japanese patients (n = 87) were generally consistent across groups. Brensocatib 10 mg and 25 mg reduced the annualized exacerbation rate vs placebo (rate ratio, 0.37 [95 % CI, 0.16–0.87]; 0.32 [0.14–0.75]), prolonged time to first exacerbation, and increased odds of remaining exacerbation-free. The annualized severe exacerbation rate was lower with brensocatib 10 mg and 25 mg vs placebo (rate ratio, 0.11 [0.01–1.04]; 0.30 [0.06–1.62]). Brensocatib, particularly at the 25 mg dose, also reduced lung function decline vs placebo (LS mean difference: forced expiratory volume in 1 s, 97 mL [95 % CI, 32–162]; forced vital capacity, 164 mL [84−244]) and improved patient-reported symptoms. Adverse events were similar across groups.
Conclusions
Consistent with overall ASPEN results, brensocatib 10 mg and 25 mg reduced exacerbation frequency vs placebo in Japanese patients with bronchiectasis. Lung function, patient-reported symptoms, and safety data were consistent with overall ASPEN trial results.
Clinical trial registration
NCT04594369.
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