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
{"title":"Long-Term Clinical and Sustained REMIssion in Severe Eosinophilic Asthma treated with Mepolizumab: The REMI-M study","authors":"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","doi":"10.1101/2024.03.13.24304254","DOIUrl":null,"url":null,"abstract":"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.\nObjective: 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.\nMethods: 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.\nResults: 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.\nConclusions: 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.","PeriodicalId":501074,"journal":{"name":"medRxiv - Respiratory Medicine","volume":"40 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"medRxiv - Respiratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1101/2024.03.13.24304254","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
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.