Step down of asthma biologics in real-world practice settings

在现实世界的实践环境中减少哮喘生物制剂

• 批准号: 9762177
• 负责人: Matthew A Rank
• 金额: $ 12.13万
• 依托单位: MAYO CLINIC ARIZONA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9762177
• 关键词: Adrenal Cortex Hormones; Affect; Aftercare; Agonist; Airway Disease; Asthma; Biological; Biological Response Modifier Therapy; Case Series; Chronic; Computerized Medical Record; Data; Data Set; Decision Making; Disease; Functional disorder; Future; Guidelines; Health; Healthcare; Immunologics; Individual; Inhalation; Length; Leukotriene Antagonists; Longterm Follow-up; Measures; Medical Care Team; Medication Management; Medicine; Methods; Morbidity - disease rate; Outcome; Pathway interactions; Patients; Pharmaceutical Preparations; Phase IV Clinical Trials; Population; Process; Public Health; Research; Risk; Risk Estimate; Sample Size; Symptoms; Testing; Treatment Cost; Withholding Treatment; Work; asthma exacerbation; asthma inhaler; asthmatic patient; base; burden of illness; clinical practice; cost; data warehouse; disease registry; experience; health care service utilization; high risk; improved; individual response; innovation; mepolizumab; omalizumab; outcome prediction; practice setting; predictive modeling; side effect

This study is being performed to help patients and their health care team work together to make decisions about managing their asthma. A new class of medicines for asthma called asthma biologics, which target very specific immunological pathways responsible for asthma, were developed. The first such medicine, omalizumab, first became available in 2003 and 2 additional medicines, mepolizumab and reslizumab, became available in 2015 and 2016, respectively. These medicines are currently intended for those who have moderate or severe asthma and who haven't responded to other asthma medicines like inhaled corticosteroids. Patients receiving asthma biologics usually have the highest burden of asthma disease. Asthma biologic medicines are very expensive and may not work for everyone. Sometimes, patients and their doctors need to make decisions about stopping asthma biologics. Right now, we do not have very good information about what happens to patients after they stop these medicines. It is important to get a better idea of the risk of stopping asthma biologic medicines and to be able predict who may be able to stop them with lower risk of future asthma attacks. The over-arching, long-term objective of the research is to improve the lives of people who have asthma. In this study, we are using a very large data set that allows us to study over 4,000 patients who have started taking the first asthma biologic, omalizumab, and then comparing what happens in patients who continue taking omalizumab with patients who stop taking omalizumab. We will then extend the same comparison to the other asthma biologic medicines, mepolizumab and reslizumab. The specific aims of the proposal are listed below. Specific Aim #1: Determine the outcomes following discontinuation of inhaled corticosteroids, mepolizumab, omalizumab, and reslizumab for asthma in real-world practice settings. Specific Aim #2: Develop and validate predictive models for safe discontinuation of asthma biologic medications. The methods we will use involve the analysis of existing data. We believe these methods will lead to a more rapid assessment than the current process for making these determinations, which include disease registries and phase IV clinical trials. When this study is complete, patients and their healthcare team will have access to more confident risk estimates for asthma biologic discontinuation, thus leading to better decisions about asthma biologic treatments and improved health for people who suffer the greatest disease burden.

进行这项研究是为了帮助患者及其医疗保健团队共同努力， 决定如何治疗哮喘。一种新的治疗哮喘的药物叫做哮喘 生物制剂，靶向非常具体的免疫途径负责哮喘， 开发首个此类药物奥马珠单抗于2003年首次上市， 2015年和2016年，其他药物，美泊利珠单抗和瑞利珠单抗， 分别这些药物目前适用于中度或重度 哮喘和对其他哮喘药物如吸入性皮质类固醇没有反应的人。 接受哮喘生物制剂的患者通常具有最高的哮喘疾病负担。 哮喘生物药物非常昂贵，可能并不适合所有人。有时候， 患者和他们的医生需要决定是否停止使用哮喘生物制剂。现在， 我们没有关于患者停止这些治疗后会发生什么的很好的信息， 药更好地了解停用哮喘生物制剂的风险是很重要的 并且能够预测谁能够阻止他们，降低未来哮喘发作的风险。 这项研究的长期目标是改善那些有 哮喘在这项研究中，我们使用了一个非常大的数据集，使我们能够研究超过4000个 开始服用第一种哮喘生物制剂奥马珠单抗的患者， 继续服用奥马珠单抗的患者和停止服用奥马珠单抗的患者 奥马珠单抗。然后，我们将同样的比较扩展到其他哮喘生物药物， 美泊利珠单抗和瑞利珠单抗。该提案的具体目标如下。 具体目标#1：确定停止吸入后的结局 皮质类固醇、美泊利珠单抗、奥马珠单抗和瑞利珠单抗在现实世界中治疗哮喘 练习设置。 具体目标#2：开发和验证安全停药的预测模型 哮喘生物药物 我们将使用的方法涉及对现有数据的分析。我们相信这些方法将 导致比当前的确定过程更快速的评估， 包括疾病登记和IV期临床试验。当这项研究完成后， 患者和他们的医疗团队将获得更有信心的哮喘风险评估 生物制剂停药，从而更好地决定哮喘生物制剂治疗， 改善疾病负担最重人群的健康状况。