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布伦索卡蒂布导致支气管扩张症肺部恶化率降低

Brensocatib Leads to Lower Rate of Pulmonary Exacerbations in Bronchiectasis

Drugs 等信源发布 2025-04-25 02:04

可切换为仅中文


THURSDAY, April 24, 2025 -- For patients with bronchiectasis, brensocatib leads to a lower annualized rate of pulmonary exacerbations, according to a study published in the April 24 issue of the

2025年4月24日,星期四 —— 一项研究显示,对于支气管扩张症患者,布伦索卡替降低了肺部恶化年发生率,该研究发表在4月24日的

New England Journal of Medicine

新英格兰医学杂志

.

James D. Chalmers, M.B., Ch.B., Ph.D., from the University of Dundee in the United Kingdom, and colleagues conducted a phase 3, double-blind trial involving patients with bronchiectasis who were randomly assigned to receive brensocatib (10 mg or 25 mg once per day) or placebo (1:1:1 ratio for adults; 2:2:1 ratio for adolescents)..

詹姆斯·D·查尔莫斯(James D. Chalmers),医学学士、外科学士、哲学博士,来自英国邓迪大学,他与同事们进行了一项第三阶段、双盲试验,涉及支气管扩张症患者,这些患者被随机分配接受布雷诺卡蒂布(每天一次10毫克或25毫克)或安慰剂(成人按1:1:1比例;青少年按2:2:1比例)。

A total of 1,680 adults and 41 adolescents were randomly assigned to brensocatib or placebo. The researchers found that the annualized rate of pulmonary exacerbations was 1.02, 1.04, and 1.29 in the 10-mg brensocatib group, 25-mg brensocatib group, and placebo group, respectively (rate ratios, 0.79 and 0.81 with the 10-mg and 25-mg brensocatib doses, respectively, versus placebo).

共有 1,680 名成年人和 41 名青少年被随机分配到布雷诺卡蒂布或安慰剂组。研究人员发现,10 毫克布雷诺卡蒂布组、25 毫克布雷诺卡蒂布组和安慰剂组的肺部恶化年化率分别为 1.02、1.04 和 1.29(与安慰剂相比,10 毫克和 25 毫克布雷诺卡蒂布剂量的比率比分别为 0.79 和 0.81)。

For the time to first exacerbation, the hazard ratio was 0.81 and 0.83 with the 10-mg and 25-mg doses, respectively. At week 52, 48.5 percent of patients in each brensocatib group remained exacerbation-free, compared with 40.3 percent in the placebo group (rate ratios, 1.20 and 1.18 with the 10-mg and 25-mg doses, respectively).

首次急性加重时间的危险比在10毫克和25毫克剂量组分别为0.81和0.83。在第52周时,各布雷诺卡蒂布组中48.5%的患者仍然没有出现急性加重,而安慰剂组为40.3%(比率分别为1.20和1.18对应于10毫克和25毫克剂量组)。

Forced expiratory volume in one second had decreased by 50, 24, and 62 mL with the 10-mg dose, 25-mg dose, and placebo, respectively, at week 52, with the reduction significant for the 25-mg dose. The incidence of adverse events was similar across groups. There was a higher incidence of hyperkeratosis with brensocatib..

在第52周时,10毫克剂量、25毫克剂量和安慰剂组的一秒钟用力呼气量分别减少了50毫升、24毫升和62毫升,25毫克剂量的减少显著。各组不良事件的发生率相似。使用Brensocatib时,角化过度的发生率较高。

'These results show that inhibiting dipeptidyl peptidase 1 with brensocatib -- and thereby targeting neutrophilic inflammation -- results in meaningful improvements in outcomes in patients with bronchiectasis,' the authors write.

“这些结果表明,使用布伦索卡替抑制二肽基肽酶1——从而靶向中性粒细胞性炎症——可显著改善支气管扩张症患者的预后,”作者写道。

The study was funded by Insmed, which is developing brensocatib.

该研究由正在开发布雷索卡替的Insmed公司资助。

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