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一项评估美泊利单抗治疗台湾地区重度哮喘有效性的真实世界研究(REMIT)。

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

作者信息

Cheng Shih-Lung, Lin Shu-Min, Peng Chung-Kan, Chan Ming-Cheng, Shen Sheng-Yeh, Kuo Ping-Hung, Lai Chien-Hao, Lan Chou-Chin, Chen Chung-Yu, Lin Ching-Hsiung, Liao Kuang-Ming, Feng Po-Hao, Wu Jiin-Torng, Wei Yu-Feng, Xu Xiaomeng, Alfonso-Christancho Rafael, Lai Tina, Navarro Aldo, Milea Dominique, Perng Diahn-Warng

机构信息

Division of Pulmonology, Far Eastern Memorial Hospital, New Taipei City, Taiwan.

Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan.

出版信息

Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666241308406. doi: 10.1177/17534666241308406.

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;  < 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;  = 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.

摘要

背景

REMIT是台湾地区首次针对重度哮喘(SA)患者进行的美泊利珠单抗有效性的真实世界研究。

目的

主要目的是评估美泊利珠单抗治疗前12个月和治疗后12个月内具有临床意义的病情加重(CSE;定义为使用口服糖皮质激素(OCS)或急诊就诊和/或住院)的变化。次要目的是评估美泊利珠单抗治疗前12个月和治疗后12个月内需要急诊就诊/住院的CSE数量以及每日维持OCS(mOCS)剂量的变化。基于无OCS、无病情加重以及哮喘控制(±肺功能稳定)情况分析了三成分和四成分临床缓解情况。

设计

REMIT是一项回顾性、观察性、自身对照研究,分析台湾地区新处方皮下注射100mg美泊利珠单抗、每4周一次的SA患者。

方法

从台湾15个医疗中心的记录中提取2018年11月1日至2020年10月31日期间索引患者的数据。

结果

共纳入170例患者:索引日期时的平均年龄为58.7岁;53.5%为女性;100%为中国人;7.1%患有慢性鼻窦炎伴鼻息肉,1.8%患有嗜酸性肉芽肿性多血管炎,1.2%患有高嗜酸性粒细胞综合征;55.7%的患者血液嗜酸性粒细胞计数>300/µL。治疗前,71.2%的患者有≥2次病情加重,28.7%的患者使用mOCS;75.3%的患者既往未接受过生物治疗,24.7%的患者从其他生物制剂转换而来。大多数患者(80.0%)完成了≥10剂美泊利珠单抗治疗。在首次给予美泊利珠单抗(索引日期)后,索引后12个月内CSE减少了46.0%(率比(RR):0.545,95%置信区间(CI):0.418 - 0.710;P < 0.0001)。需要急诊就诊/住院的病情加重减少了46.9%(RR:

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed66/11744627/3d1fd6a752d9/10.1177_17534666241308406-img2.jpg

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