A real-world study to evaluate effectiveness of mepolizumab in treating severe asthma in Taiwan (REMIT).

IF 3.3 3区 医学 Q2 RESPIRATORY SYSTEM
Shih-Lung Cheng, Shu-Min Lin, Chung-Kan Peng, Ming-Cheng Chan, Sheng-Yeh Shen, Ping-Hung Kuo, Chien-Hao Lai, Chou-Chin Lan, Chung-Yu Chen, Ching-Hsiung Lin, Kuang-Ming Liao, Po-Hao Feng, Jiin-Torng Wu, Yu-Feng Wei, Xiaomeng Xu, Rafael Alfonso-Christancho, Tina Lai, Aldo Navarro, Dominique Milea, Diahn-Warng Perng
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引用次数: 0

Abstract

Background: REMIT is the first real-world study of mepolizumab effectiveness in patients with severe asthma (SA) in Taiwan.

Objectives: The primary objective evaluated changes in clinically significant exacerbations (CSEs; defined as use of oral corticosteroids (OCS) or emergency department (ED) visits and/or hospitalizations) in the 12 months pre- and post-mepolizumab treatment. Secondary objectives assessed changes in the number of CSEs requiring ED visits/hospitalizations and daily maintenance OCS (mOCS) dosage 12 months pre- and post-mepolizumab treatment. Three- and four-component clinical remissions were analyzed based on OCS-free, exacerbation-free, and asthma control (± stability in lung function).

Design: REMIT was a retrospective, observational, self-controlled study analyzing patients in Taiwan with SA who were newly prescribed subcutaneous mepolizumab 100 mg Q4W.

Methods: Data were extracted from records of 15 medical centers in Taiwan for patients indexed between November 1, 2018 and October 31, 2020.

Results: A total of 170 patients were included: mean age at index date, 58.7 years; 53.5% female; 100% Chinese; 7.1% with chronic rhinosinusitis with nasal polyps, 1.8% with eosinophilic granulomatosis with polyangiitis, 1.2% with hypereosinophilic syndrome; and 55.7% with blood eosinophil count >300/µL. Pre-treatment, 71.2% had ⩾2 exacerbations, and 28.7% were on mOCS; 75.3% had no prior biologic treatment, and 24.7% had switched from other biologics. Most patients (80.0%) completed ⩾10 mepolizumab doses. Following the first mepolizumab administration (index date), CSEs reduced by 46.0% (rate ratio (RR): 0.545, 95% confidence interval (CI): 0.418-0.710; p < 0.0001) in the 12 months post-index. Exacerbations requiring ED visits/hospitalization reduced by 46.9% (RR: 0.531, 95% CI: 0.349-0.808; p = 0.0031). Median mOCS dose reduced by 100% by end of study and 81.8% of patients discontinued mOCS post-treatment. After 1 year of mepolizumab treatment, 28% and 23% patients achieved three- and four-component clinical remission, respectively.

Conclusion: Mepolizumab use in a patient population in Taiwan with SA significantly reduced CSEs and mOCS use in routine clinical practice.

一项评估美波珠单抗治疗台湾严重哮喘疗效的真实世界研究(REMIT)。
背景:REMIT是台湾首个mepolizumab对严重哮喘(SA)患者有效性的真实研究。目的:主要目的评估临床显著加重(CSEs;定义为在美珠单抗治疗前和治疗后的12个月内使用口服皮质类固醇(OCS)或急诊(ED)就诊和/或住院。次要目标评估需要ED就诊/住院和每日维持OCS (mOCS)剂量的CSEs数量在美珠单抗治疗前后12个月的变化。基于无ocs、无加重和哮喘控制(±肺功能稳定性)对三组分和四组分临床缓解进行分析。设计:REMIT是一项回顾性、观察性、自我对照的研究,分析了台湾新开皮下mepolizumab 100mg Q4W的SA患者。方法:数据提取自台湾15家医疗中心2018年11月1日至2020年10月31日检索的患者记录。结果:共纳入170例患者:指数日平均年龄58.7岁;53.5%的女性;100%的中国;7.1%为慢性鼻窦炎伴鼻息肉,1.8%为嗜酸性肉芽肿病伴多血管炎,1.2%为嗜酸性粒细胞增多综合征;55.7%的人血嗜酸性粒细胞计数为100 300/µL。治疗前,71.2%的患者出现大于或等于2的恶化,28.7%的患者接受mOCS治疗;75.3%的患者之前没有接受过生物制剂治疗,24.7%的患者是从其他生物制剂转行的。大多数患者(80.0%)完成了小于10次mepolizumab剂量。第一次给药(指标日期)后,CSEs降低46.0%(比率比(RR): 0.545, 95%可信区间(CI): 0.418-0.710;p = 0.0031)。研究结束时,mOCS的中位剂量减少了100%,81.8%的患者在治疗后停用了mOCS。经过1年的mepolizumab治疗,28%和23%的患者分别达到了三组分和四组分的临床缓解。结论:在台湾SA患者群体中使用Mepolizumab可显著降低CSEs和mOCS在常规临床实践中的使用。
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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来源期刊
CiteScore
6.90
自引率
0.00%
发文量
57
审稿时长
15 weeks
期刊介绍: Therapeutic Advances in Respiratory Disease delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of respiratory disease.
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