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在真实世界实践中,瑞利珠单抗治疗成人严重嗜酸性粒细胞性哮喘的临床结局和医疗资源利用。

Clinical Outcomes and Health-Care Resource Use Associated With Reslizumab Treatment in Adults With Severe Eosinophilic Asthma in Real-World Practice.

机构信息

National Jewish Health, Denver, CO.

Wake Forest School of Medicine, Winston-Salem, NC.

出版信息

Chest. 2021 May;159(5):1734-1746. doi: 10.1016/j.chest.2020.11.060. Epub 2020 Dec 14.

Abstract

BACKGROUND

Reslizumab, an anti-IL-5 monoclonal antibody, is indicated as add-on maintenance treatment for adults with severe eosinophilic asthma.

RESEARCH QUESTION

What are the real-world outcomes associated with reslizumab use in patients with severe eosinophilic asthma in a US clinical practice?

STUDY DESIGN AND METHODS

In this retrospective study, patient-level data from adults treated with reslizumab were obtained from center- and panel-based medical chart reviews. Eligible patients had available medical records and treatment history for ≥ 6 months before initiation of reslizumab treatment (index date) to ≥ 7 months after reslizumab initiation. The primary outcome was response to reslizumab treatment, based on clinical expert predefined definitions of response. Other outcomes included clinical asthma exacerbations (CAEs), use of maintenance oral corticosteroids (OCS), FEV percent predicted, Asthma Control Test (ACT) score, and health-care resource use (HRU).

RESULTS

Medical charts were obtained for 215 patients. Most patients (58.6%) showed an excellent response, 16.3% showed a clinically meaningful response, 21.9% showed a partial response, and 3.3% were nonresponders or treatment failures. A significant reduction was observed in the proportion of patients experiencing a CAE in a 6-month period (from 86.0% to 40.5%; P < .001) and in the mean number of CAEs per patient (2.84 [SD, 2.41] vs 0.94 [SD, 1.86]) after reslizumab initiation. Improvements were observed in FEV percent predicted (65.1% [SD, 20.5%] vs 73.1% [SD, 23.1%]; P < .001) and in ACT scores (13.8 [SD, 4.2] vs 18.6 [SD, 4.0]; P < .001) before to after reslizumab initiation. Among patients using maintenance OCS at baseline, more than half discontinued use of these by approximately 10 months after reslizumab initiation. Significant reductions in asthma-related HRU were observed after reslizumab initiation.

INTERPRETATION

In clinical practice, reslizumab may have been initiated in response to heavy symptom burden and CAEs. Reslizumab was associated with improved clinical and patient-reported outcomes and significant reductions in asthma-related HRU.

摘要

背景

抗白细胞介素-5 单克隆抗体雷利珠单抗被批准用于治疗成人重度嗜酸性粒细胞性哮喘的附加维持治疗。

研究问题

在真实世界的美国临床实践中,雷利珠单抗治疗重度嗜酸性粒细胞性哮喘患者的疗效如何?

研究设计与方法

在这项回顾性研究中,从中心和基于小组的病历审查中获取了接受雷利珠单抗治疗的成年患者的患者水平数据。符合条件的患者在开始雷利珠单抗治疗(索引日期)前有≥6 个月的可用病历和治疗史,在开始雷利珠单抗治疗后有≥7 个月的记录。主要结局是根据临床专家预先定义的反应标准,评估雷利珠单抗治疗的反应。其他结局包括临床哮喘加重(CAE)、维持口服皮质类固醇(OCS)的使用、FEV%预计值、哮喘控制测试(ACT)评分和卫生保健资源使用(HRU)。

结果

共获取了 215 名患者的病历。大多数患者(58.6%)表现出极好的反应,16.3%表现出有临床意义的反应,21.9%表现出部分反应,3.3%为无反应或治疗失败。在雷利珠单抗治疗后,6 个月内发生 CAE 的患者比例(从 86.0%降至 40.5%;P<0.001)和每位患者的 CAE 平均次数(从 2.84[SD,2.41]降至 0.94[SD,1.86])显著减少。在雷利珠单抗治疗后,FEV%预计值(从 65.1%[SD,20.5%]升至 73.1%[SD,23.1%];P<0.001)和 ACT 评分(从 13.8[SD,4.2]升至 18.6[SD,4.0];P<0.001)均有改善。在基线时使用维持性 OCS 的患者中,有一半以上在雷利珠单抗治疗后大约 10 个月停止使用 OCS。雷利珠单抗治疗后,哮喘相关 HRU 显著减少。

解释

在临床实践中,雷利珠单抗可能是为了应对严重的症状负担和 CAE 而开始使用的。雷利珠单抗与改善的临床和患者报告的结果以及哮喘相关 HRU 的显著减少有关。

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