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口服芬戈莫德与传统注射用疾病修饰药物治疗多发性硬化症的疗效比较

Comparative treatment effectiveness of oral fingolimod and conventional injectable disease-modifying agents in multiple sclerosis.

作者信息

Earla Jagadeswara R, Hutton George J, Thornton Douglas J, Chen Hua, Johnson Michael L, Aparasu Rajender R

机构信息

Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, Houston, Texas, USA.

Baylor College of Medicine, Houston, Texas, USA.

出版信息

Pharmacotherapy. 2021 May;41(5):440-450. doi: 10.1002/phar.2517. Epub 2021 Mar 18.

Abstract

STUDY OBJECTIVE

To compare the effectiveness of oral fingolimod and conventional injectable disease-modifying agents (DMAs) using the composite endpoint of relapse or DMA treatment switch in patients with multiple sclerosis (MS).

DESIGN

A retrospective longitudinal cohort study.

DATA SOURCE

IBM MarketScan Commercial Claims and Encounters Database from 2010-2012.

PATIENTS

Adults (≥18 years) with MS diagnosis (ICD-9-CM:340) who newly initiated DMAs.

INTERVENTION

Oral fingolimod and conventional injectable DMAs (interferon beta and glatiramer acetate).

MEASUREMENTS

Composite endpoint of time to relapse or DMA treatment switch.

MAIN RESULTS

The incident study cohort consisted of 1997 MS patients who initiated oral fingolimod (15.6%) or injectable (84.4%) DMAs. The proportion of patients who had a composite endpoint (relapse/DMA treatment switch) in oral fingolimod and injectable DMA users was found to be 16.72% and 27.16%, respectively. The Cox PH regression model with stabilized IPTW revealed that fingolimod is equally effective as conventional injectable DMAs in reducing the risk of experiencing the composite endpoint of relapse or DMA switch (adjusted hazard ratio [aHR]: 0.67, 95% CI: 0.43-1.03). Additional analysis among patients who were adherent also found no significant difference in the composite endpoint (aHR: 0.70, 95% CI 0.49-1.15) between oral fingolimod and injectable DMA users.

CONCLUSIONS

Oral fingolimod has similar effectiveness as conventional injectable DMAs in reducing the risk of experiencing the composite endpoint (relapse or DMA treatment switch). In addition, when assessed independently, oral fingolimod showed no difference in reducing the time to relapse or DMA treatment switch compared to injectable DMAs.

摘要

研究目的

使用复发或疾病修正治疗药物(DMA)治疗转换的复合终点,比较口服芬戈莫德与传统注射用疾病修正治疗药物(DMA)在多发性硬化症(MS)患者中的疗效。

设计

一项回顾性纵向队列研究。

数据来源

2010 - 2012年IBM MarketScan商业理赔与病历数据库。

患者

新开始使用DMA的成年(≥18岁)MS诊断患者(国际疾病分类第九版临床修正本:340)。

干预措施

口服芬戈莫德和传统注射用DMA(干扰素β和醋酸格拉替雷)。

测量指标

复发或DMA治疗转换时间的复合终点。

主要结果

纳入研究队列的1997例MS患者开始使用口服芬戈莫德(15.6%)或注射用(84.4%)DMA。口服芬戈莫德组和注射用DMA组达到复合终点(复发/DMA治疗转换)的患者比例分别为16.72%和27.16%。采用稳定逆概率加权法(IPTW)的Cox PH回归模型显示,在降低复发或DMA转换复合终点风险方面,芬戈莫德与传统注射用DMA效果相当(校正风险比[aHR]:0.67,95%置信区间:0.43 - 1.03)。对依从性患者的进一步分析还发现,口服芬戈莫德组和注射用DMA组在复合终点方面无显著差异(aHR:0.70,95%置信区间0.49 - 1.15)。

结论

口服芬戈莫德在降低复合终点(复发或DMA治疗转换)风险方面与传统注射用DMA效果相似。此外,单独评估时,与注射用DMA相比,口服芬戈莫德在缩短复发或DMA治疗转换时间方面无差异。

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