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长效毒蕈碱拮抗剂和生物制剂在美国中重度哮喘患者的附加治疗中的应用。

Usage of long-acting muscarinic antagonists and biologics as add-on therapy for patients in the United States with moderate-to-severe asthma.

机构信息

Genentech, Inc, South San Francisco, CA, USA.

Genesis Research, Hoboken, NJ, USA.

出版信息

J Asthma. 2022 Jun;59(6):1237-1247. doi: 10.1080/02770903.2021.1922915. Epub 2021 May 22.

Abstract

Many asthma patients remain uncontrolled on inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs), but guidance for selecting add-on therapies, including long-acting muscarinic antagonists (LAMAs) or biologics, is limited. We describe how prescribing practices for add-on LAMA and biologic therapy have changed with increased treatment options and revised treatment guidelines. We further identify differences in treatment initiation and discontinuation rates by patient characteristics, including concomitant COPD. This retrospective cohort study analyzed insurance claims in the IBM Marketscan database for adult US asthma patients treated with medium- or high-dose ICS/LABA between 2012 and 2019 ( = 277,373). We used negative binomial regression models to evaluate LAMA and biologic initiation rates and their association with patient characteristics, and survival analysis methods for assessing discontinuation rates. Between 2012 and 2019, LAMA and biologic uptake increased approximately 5-fold and 20-fold, respectively. LAMA initiation was significantly higher among patients with concomitant COPD, a group typically unstudied in clinical trials, versus those with asthma only (rate ratio of 5.90, 95% CI: 5.76-6.04). High-dose ICS/LABA treatment and the need for oral corticosteroid (OCS) bursts had stronger associations with biologic initiation. Probability of discontinuation (i.e. non-persistence) in the first year was 40.5% and 22.7% for those initiating LAMAs and biologics, respectively, with higher LAMA discontinuation rates among patients with asthma only versus those with concomitant COPD. Our results provide insights into how clinicians apply treatment guidelines for initiating add-on LAMA and biologic therapies in moderate-to-severe asthma patients and highlight patients who have an unmet treatment need after discontinuation.

摘要

许多哮喘患者在吸入皮质类固醇(ICS)和长效β激动剂(LABA)的治疗下仍未得到控制,但对于附加治疗选择的指导,包括长效抗胆碱能药物(LAMA)或生物制剂,是有限的。我们描述了随着治疗选择和修订的治疗指南的增加,附加 LAMA 和生物制剂治疗的处方实践是如何改变的。我们还根据患者特征,包括同时患有 COPD,进一步确定了治疗开始和停止率的差异。这项回顾性队列研究分析了 IBM Marketscan 数据库中 2012 年至 2019 年间接受中或高剂量 ICS/LABA 治疗的美国成年哮喘患者的保险索赔( = 277373)。我们使用负二项回归模型评估 LAMA 和生物制剂的起始率及其与患者特征的关系,并使用生存分析方法评估停药率。在 2012 年至 2019 年间,LAMA 和生物制剂的使用量分别增加了约 5 倍和 20 倍。在同时患有 COPD 的患者中,LAMA 的起始率明显高于仅患有哮喘的患者(比率比为 5.90,95%CI:5.76-6.04),这是临床试验中通常未研究的一组患者。高剂量 ICS/LABA 治疗和口服皮质类固醇(OCS)爆发的需求与生物制剂的起始具有更强的关联。在第一年,起始 LAMA 和生物制剂的患者的停药(即非持续)概率分别为 40.5%和 22.7%,在仅患有哮喘的患者中,LAMA 的停药率高于同时患有 COPD 的患者。我们的研究结果提供了有关临床医生如何在中重度哮喘患者中应用起始附加 LAMA 和生物制剂治疗的指导原则的见解,并强调了停药后治疗需求未得到满足的患者。

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