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重度嗜酸性粒细胞性哮喘患者瑞利珠单抗的真实世界疗效 - 初治患者和转换治疗患者。

Real-World Effectiveness of Reslizumab in Patients With Severe Eosinophilic Asthma - First Initiators and Switchers.

机构信息

Department of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Department of Clinical Pharmacy and Pharmacology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.

出版信息

J Allergy Clin Immunol Pract. 2022 Aug;10(8):2099-2108.e6. doi: 10.1016/j.jaip.2022.04.014. Epub 2022 Apr 26.

DOI:10.1016/j.jaip.2022.04.014
PMID:35487369
Abstract

BACKGROUND

Reslizumab, a biologic targeting IL-5, has been shown to reduce asthma exacerbations and maintenance oral corticosteroid use in randomized controlled trials and pre-post studies in patients with severe eosinophilic asthma. However, real-world effectiveness data of reslizumab are scarce, and it is unknown whether reslizumab has added value after switching from another type 2 biologic.

OBJECTIVE

To evaluate (1) the real-world effectiveness of reslizumab on severe asthma exacerbations, maintenance oral corticosteroid use, and overall treatment response, both in biologic-naive patients who initiated reslizumab and in those who switched from another type 2 biologic; and (2) physicians' experience with reslizumab treatment.

METHODS

This observational real-world study evaluated data from 134 adults with severe eosinophilic asthma included in the Dutch severe asthma registry (RAPSODI), who initiated reslizumab treatment (4-weekly infusions, 0.3 mg/kg) before April 2020 and had follow-up data for 6 months and greater. Clinical asthma experts completed surveys on their experience with reslizumab treatment.

RESULTS

Overall, reslizumab reduced the exacerbation rate (odds ratio [95% CI] = 0.10 [0.05-0.21]; P < .001), oral corticosteroid use (OR [95% CI], 0.2 [0.0-0.5]; P < .001), and maintenance dose (median [CI], 5.0 [0.0-10.0] to 0.0 [0.0-5.0]; P < .001), with comparable results in biologic-naive reslizumab initiators and switchers. The overall response to reslizumab was graded good or excellent in 59.2% of patients. The additive effectiveness of reslizumab after switching from another biologic was reflected in physicians' surveys.

CONCLUSIONS

Real-world data show that reslizumab reduces severe asthma exacerbations and oral corticosteroid use in patients with severe eosinophilic asthma, both in biologic-naive reslizumab initiators and in those who switched from another type 2 biologic. This additional value of reslizumab was recognized by clinical asthma experts.

摘要

背景

白介素 5(IL-5)拮抗剂瑞利珠单抗已被证实可减少重度嗜酸性粒细胞性哮喘患者的哮喘加重和维持口服皮质类固醇的使用,在随机对照试验和前后研究中均得到证实。然而,瑞利珠单抗的实际有效性数据仍然很少,并且尚不清楚在从另一种 2 型生物制剂转换后,瑞利珠单抗是否具有附加价值。

目的

评估(1)在开始瑞利珠单抗治疗的生物制剂初治患者和从另一种 2 型生物制剂转换而来的患者中,瑞利珠单抗治疗对重度哮喘加重、维持口服皮质类固醇使用和整体治疗反应的真实世界疗效;(2)医生使用瑞利珠单抗治疗的经验。

方法

这项观察性真实世界研究评估了荷兰重度哮喘登记处(RAPSODI)中纳入的 134 名重度嗜酸性粒细胞性哮喘成人患者的数据,这些患者在 2020 年 4 月之前开始接受瑞利珠单抗治疗(4 周 1 次输注,0.3mg/kg),并且有 6 个月或更长时间的随访数据。临床哮喘专家完成了关于瑞利珠单抗治疗经验的调查问卷。

结果

总体而言,瑞利珠单抗降低了哮喘加重的发生率(比值比[95%置信区间]为 0.10[0.05-0.21];P<0.001)、口服皮质类固醇的使用(比值比[95%置信区间]为 0.2[0.0-0.5];P<0.001)和维持剂量(中位数[CI]为 5.0[0.0-10.0]降至 0.0[0.0-5.0];P<0.001),在生物制剂初治的瑞利珠单抗起始患者和转换患者中结果相似。瑞利珠单抗的总体治疗反应在 59.2%的患者中被评为良好或优秀。从另一种生物制剂转换后瑞利珠单抗的附加疗效在医生的调查中得到了反映。

结论

真实世界的数据表明,瑞利珠单抗可减少重度嗜酸性粒细胞性哮喘患者的哮喘加重和口服皮质类固醇的使用,在生物制剂初治的瑞利珠单抗起始患者和从另一种 2 型生物制剂转换而来的患者中均有效果。这一额外的疗效得到了临床哮喘专家的认可。

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