美妥珠单抗治疗严重嗜酸性粒细胞性哮喘的长期临床和持续 REMIssion:REMI-M 研究

Claudia Crimi, Santi Nolasco, Alberto Noto, Angelantonio Maglio, Vitaliano Nicola Quaranta, Danilo Di Bona, Giulia Scioscia, Francesco Papia, Maria Filomena Caiaffa, Cecilia Calabrese, Maria D'Amato, Corrado Pelaia, Raffaele Campisi, Carolina Vitale, Luigi Ciampo, Silvano Dragonieri, Elena Minenna, Federica Massaro, Lorena Gallotti, Luigi Macchia, Massimo Triggiani, Nicola Scichilone, Giuseppe Valenti, Girolamo Pelaia, Maria Pia Foschino Barbaro, Giovanna Elisiana Carpagnano, Alessandro Vatrella, Nunzio Crimi
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引用次数: 0

摘要

背景:mepolizumab等生物疗法改变了严重嗜酸性粒细胞性哮喘的治疗方法。虽然美妥珠单抗的短期疗效已得到证实,但有关其实现长期临床缓解的能力的证据却很有限:评估甲泼尼珠单抗的长期有效性和安全性,探索其诱导临床和持续缓解的潜力,并确定与24个月内实现缓解的可能性相关的基线因素:REMI-M是一项回顾性、真实世界、多中心研究,分析了303名接受过麦波利珠单抗治疗的重度嗜酸性粒细胞哮喘患者。在基线、3、6、12 和 24 个月时收集了临床、人口统计学和安全性数据。采用了最常用的临床缓解定义,包括无病情加重、无口服皮质类固醇(OCS)使用、哮喘控制良好(可评估或不评估肺功能参数)。持续缓解的定义是在12个月内达到临床缓解,并在24个月内保持缓解:根据不同的缓解定义,12 个月后的临床缓解率为 28.6% 至 43.2%,24 个月后的临床缓解率为 26.8% 至 52.9%。获得持续缓解的患者比例从14.6%到29%不等。与获得临床缓解的可能性相关的因素包括:存在阿司匹林加重的呼吸系统疾病、肺功能较好、男性、无焦虑/抑郁、胃食管反流病、支气管扩张以及减少使用 OCS。不良反应不常见:这项研究证明了麦泊利单抗在 24 个月内实现重度嗜酸性粒细胞哮喘临床缓解和持续缓解的实际效果。与实现临床缓解的可能性相关的独特因素的确定强调了综合管理合并症和及时发现可能从生物制剂中获益的患者的重要性。
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Long-Term Clinical and Sustained REMIssion in Severe Eosinophilic Asthma treated with Mepolizumab: The REMI-M study
Background: Biological therapies, such as mepolizumab, have transformed the treatment of severe eosinophilic asthma. While mepolizumab's short-term effectiveness is established, there is limited evidence on its ability to achieve long-term clinical remission. Objective: To evaluate the long-term effectiveness and safety of mepolizumab, explore its potential to induce clinical and sustained remission, and identify baseline factors associated with the likelihood of achieving remission over 24 months. Methods: The REMI-M is a retrospective, real-world, multicenter study that analyzed 303 severe eosinophilic asthma patients who received mepolizumab. Clinical, demographic, and safety data were collected at baseline, 3, 6, 12, and 24 months. The most commonly used definitions of clinical remission, which included no exacerbations, no oral corticosteroids (OCS) use, and good asthma control with or without assessment of lung function parameters, were adopted. Sustained remission was defined as reaching clinical remission at 12 months and maintaining it until the end of the 24-month period. Results: Clinical remission rates ranged from 28.6% to 43.2% after 12 months and from 26.8% to 52.9% after 24 months, based on the different remission definitions. The proportion of patients achieving sustained remission varied between 14.6% to 29%. Factors associated with the likelihood of achieving clinical remission included the presence of aspirin-exacerbated respiratory disease, better lung function, male sex, absence of anxiety/depression, gastro-esophageal reflux disease, bronchiectasis, and reduced OCS consumption. Adverse events were infrequent. Conclusions: This study demonstrates the real-world effectiveness of mepolizumab in achieving clinical remission and sustained remission in severe eosinophilic asthma over 24 months. The identification of distinct factors associated with the likelihood of achieving clinical remission emphasizes the importance of comprehensive management of comorbidities and timely identification of patients who may benefit from biologics.
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