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美泊利珠单抗治疗重度嗜酸性粒细胞性哮喘的真实世界有效性和安全性:来自韩国重度哮喘登记研究(KoSAR)的见解

Real-World Effectiveness and Safety of Mepolizumab in Severe Eosinophilic Asthma: Insights From the Korean Severe Asthma Registry (KoSAR).

作者信息

Park So-Young, Lee Daegeun, Kim Joo-Hee, Lee Youngsoo, Ban Ga-Young, Sim Da Woon, Kwon Jae-Woo, Kim So Ri, Song Woo-Jung, Park Heung-Woo, Chang Yoon-Seok, Koh Young-Il, Lee Byung-Jae, Park Hae-Sim, Cho You Sook, Kim Sang-Heon

机构信息

Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Korea.

Division of Pulmonary Medicine, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, Anyang, Korea.

出版信息

Allergy Asthma Immunol Res. 2025 May;17(3):384-393. doi: 10.4168/aair.2025.17.3.384.

Abstract

Mepolizumab, an interleukin-5 antagonist, is globally recognized for its efficacy in randomized controlled trials for the treatment of severe eosinophilic asthma. The present study explored its real-world effectiveness and safety in a Korean cohort, filling a critical gap in current research. This multi-center retrospective study used data from the Korean Severe Asthma Registry, involving 67 patients treated with mepolizumab for uncontrolled severe asthma between September 2017 and July 2022. We assessed the effects of treatment on acute exacerbations, oral corticosteroid (OCS) maintenance dose, lung function, and quality of life. The notable findings included a marked reduction in the proportion of patients experiencing acute exacerbations, with 73.0% of patients reporting no exacerbations during the 6-month treatment period. At baseline, 31.8% of patients had reported no exacerbations over the prior 12 months. The OCS maintenance doses also decreased substantially, with only 3.2% of patients requiring OCS after 6 months. Additionally, there was an improvement in lung function. No severe adverse reactions were reported in this study, highlighting the safety of mepolizumab. This study confirmed that mepolizumab reduced exacerbations and OCS use, with additional improvements seen in asthma control, lung function, and patient-reported quality of life. These real-world findings support broader applications and reinforce the need for further research to optimize treatment strategies. Despite certain limitations, such as the small sample size and retrospective design, this study significantly contributes to the understanding of the real-world efficacy and safety of mepolizumab.

摘要

美泊利珠单抗是一种白细胞介素-5拮抗剂,在治疗重度嗜酸性粒细胞性哮喘的随机对照试验中的疗效已得到全球认可。本研究探讨了其在韩国队列中的真实疗效和安全性,填补了当前研究中的关键空白。这项多中心回顾性研究使用了韩国重度哮喘登记处的数据,纳入了2017年9月至2022年7月期间67例接受美泊利珠单抗治疗的重度未控制哮喘患者。我们评估了治疗对急性加重、口服糖皮质激素(OCS)维持剂量、肺功能和生活质量的影响。显著发现包括经历急性加重的患者比例显著降低,73.0%的患者在6个月治疗期内未出现加重。基线时,31.8%的患者在过去12个月内未出现加重。OCS维持剂量也大幅下降,6个月后仅3.2%的患者需要使用OCS。此外,肺功能有所改善。本研究未报告严重不良反应,突出了美泊利珠单抗的安全性。本研究证实美泊利珠单抗减少了急性加重和OCS的使用,在哮喘控制、肺功能和患者报告的生活质量方面也有额外改善。这些真实世界的发现支持更广泛的应用,并强化了进一步研究以优化治疗策略的必要性。尽管存在某些局限性,如样本量小和回顾性设计,但本研究对理解美泊利珠单抗的真实疗效和安全性有显著贡献。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccef/12117481/cfafa8514355/aair-17-384-g001.jpg

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