根据患者特征，重度嗜酸性粒细胞性哮喘换用美泊利珠单抗相比于奥马珠单抗的获益。

Benefit of switching to mepolizumab from omalizumab in severe eosinophilic asthma based on patient characteristics.

机构信息

Divisions of Allergy and Clinical Immunology, Pulmonary and Critical Care Medicine, Johns Hopkins Asthma and Allergy Center, Baltimore, MD, USA.

Capital Allergy and Respiratory Disease Center, Sacramento, CA, USA.

出版信息

Respir Res. 2021 May 10;22(1):144. doi: 10.1186/s12931-021-01733-9.

DOI:10.1186/s12931-021-01733-9

PMID:33971856

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8111733/

Abstract

BACKGROUND

The OSMO study assessed the efficacy of switching to mepolizumab in patients with severe eosinophilic asthma that was uncontrolled whilst receiving omalizumab. The objective of this analysis was to assess the proportion of patients achieving pre-defined improvements in up to four efficacy outcomes and the relationship between patient baseline characteristics and treatment response.

METHODS

This was a post hoc analysis of OSMO study data (GSK ID:204471; ClinicalTrials.gov No. NCT02654145). Patients with severe eosinophilic asthma uncontrolled by high-dose inhaled corticosteroids, other controller(s) and omalizumab subcutaneously (≥ 4 months) were switched to mepolizumab 100 mg administered subcutaneously. Endpoints included the proportion of responders-i.e. patients achieving a pre-defined clinical improvement in ≥ 1 of the following outcomes: (1) Asthma Control Questionnaire (ACQ)-5 score (≥ 0.5-points), (2) St George's Respiratory Questionnaire (SGRQ) total score (≥ 4-points), (3) pre-bronchodilator forced expiratory volume in 1s (FEV; ≥ 100 mL), all at Week 32, and (4) annualised rate of clinically significant exacerbations (≥ 50% reduction).

RESULTS

Of the 145 patients included, 94%, 83%, 63% and 31% were responders for ≥ 1, ≥ 2, ≥ 3 and 4 outcomes, respectively; 75% and 78% were ACQ-5 and SGRQ score responders, and 50% and 69% were FEV and exacerbation responders. Subgroup analyses demonstrated improvements irrespective of baseline blood eosinophil count, prior omalizumab treatment regimen/duration, comorbidities, prior exacerbation history, maintenance oral corticosteroid use, ACQ-5 and SGRQ scores, and body weight/body mass index.

CONCLUSIONS

After switching to mepolizumab, almost all patients with uncontrolled severe eosinophilic asthma on omalizumab achieved a beneficial response in ≥ 1 clinical outcome. Improvements were observed regardless of baseline characteristics. Trial registration This manuscript is a post hoc analysis of data from the OSMO study. ClinicalTrials.gov, NCT02654145. Registered January 13, 2016.

摘要

背景

OSMO 研究评估了在接受奥马珠单抗治疗时未能控制的重度嗜酸性粒细胞性哮喘患者中转换为美泊利珠单抗的疗效。本分析的目的是评估达到多达四个疗效终点预定义改善的患者比例，以及患者基线特征与治疗反应之间的关系。

方法

这是 OSMO 研究数据的事后分析（GSK 编号：204471；ClinicalTrials.gov 编号：NCT02654145）。在高剂量吸入性皮质激素、其他控制药物和奥马珠单抗皮下治疗（≥4 个月）控制不佳的重度嗜酸性粒细胞性哮喘患者转换为美泊利珠单抗 100mg 皮下给药。终点包括以下至少一种疗效指标的预定义改善的应答者比例：（1）哮喘控制问卷（ACQ）-5 评分（≥0.5 分），（2）圣乔治呼吸问卷（SGRQ）总评分（≥4 分），（3）支气管扩张剂前用力呼气量（FEV；≥100mL），均在第 32 周，（4）临床显著加重的年化率（≥50%降低）。

结果

在纳入的 145 例患者中，≥1、≥2、≥3 和 4 个终点的应答者比例分别为 94%、83%、63%和 31%；75%和 78%的患者是 ACQ-5 和 SGRQ 评分的应答者，50%和 69%的患者是 FEV 和加重的应答者。亚组分析表明，无论基线血嗜酸性粒细胞计数、奥马珠单抗治疗方案/时间、合并症、既往加重史、维持口服皮质激素使用、ACQ-5 和 SGRQ 评分、体重/体重指数如何，均有改善。