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美泊利珠单抗治疗重症哮喘的真实疗效:系统文献回顾。

Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review.

机构信息

Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.

Personalized Medicine Asthma and Allergy Clinic, Department of Biomedical Sciences, Humanitas University and Research Hospital-IRCCS, Rozzano, Milan, Italy.

出版信息

J Asthma. 2022 Nov;59(11):2201-2217. doi: 10.1080/02770903.2021.2008431. Epub 2021 Dec 24.

Abstract

OBJECTIVE

The efficacy and safety of mepolizumab in patients with severe eosinophilic asthma in randomized controlled trials is well established. Following approval of mepolizumab as add-on therapy for severe eosinophilic asthma in multiple regions worldwide, it is now important to determine its impact in real-world settings in which patients are not subject to stringent eligibility criteria. This systematic literature review assessed published evidence of clinical outcomes, safety, and healthcare resource use among patients with severe asthma receiving mepolizumab in real-world settings.

DATA SOURCES

Searches were conducted in Embase, MEDLINE, and MEDLINE In-Process via Ovid.

STUDY SELECTIONS

Eligible studies were observational, and enrolled ≥10 patients with asthma who received mepolizumab 100 mg subcutaneously. Data extracted included annualized exacerbation rate, mean daily oral corticosteroid (OCS) dose, proportion of patients using OCS, several measures of lung function, patient-reported asthma control and health-related quality of life (HRQoL), safety, and economic burden.

RESULTS

Twenty-three articles (22 unique studies; 2,040 patients with severe asthma on mepolizumab) were identified. Mepolizumab use was associated with a reduction in annualized exacerbation rates (requiring OCS) of 54-97% ( < 0.05 in all studies), reduced mean/median daily OCS doses, and OCS discontinuation during follow-up (27-84% of patients). Improvements in lung function, asthma control, and HRQoL were also observed. The most commonly reported adverse events included headache and arthralgia; discontinuation of mepolizumab due to adverse events occurred in 0-10.6% of patients.

CONCLUSION

Findings show that patients with severe asthma consistently demonstrate clinically relevant benefits with mepolizumab treatment in a real-world setting.

UNLABELLED

Supplemental data for this article is available online at at www.tandfonline.com/ijas .

摘要

目的

在随机对照试验中,美泊利珠单抗在重度嗜酸性粒细胞性哮喘患者中的疗效和安全性已得到充分证实。美泊利珠单抗在多个地区被批准作为重度嗜酸性粒细胞性哮喘的附加疗法后,现在重要的是要确定其在现实环境中的影响,因为在现实环境中,患者不受严格的入选标准限制。本系统文献回顾评估了在现实环境中接受美泊利珠单抗治疗的重度哮喘患者的临床结局、安全性和医疗资源使用情况的已发表证据。

数据来源

通过 Ovid 在 Embase、MEDLINE 和 MEDLINE In-Process 中进行了检索。

研究选择

合格的研究是观察性的,纳入了≥10 名接受美泊利珠单抗 100mg 皮下注射的哮喘患者。提取的数据包括年化恶化率、平均每日口服皮质类固醇(OCS)剂量、使用 OCS 的患者比例、几项肺功能测量、患者报告的哮喘控制和健康相关生活质量(HRQoL)、安全性和经济负担。

结果

确定了 23 篇文章(22 项独特研究;2040 名接受美泊利珠单抗治疗的重度哮喘患者)。美泊利珠单抗的使用与年化恶化率(需要 OCS)降低 54-97%(所有研究均<0.05)、平均/中位数每日 OCS 剂量降低以及随访期间 OCS 停药(27-84%的患者)相关。还观察到肺功能、哮喘控制和 HRQoL 的改善。最常报告的不良事件包括头痛和关节痛;由于不良事件而停用美泊利珠单抗的患者为 0-10.6%。

结论

研究结果表明,在现实环境中,重度哮喘患者接受美泊利珠单抗治疗始终表现出具有临床意义的获益。

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