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与多发性硬化症患者口服芬戈莫德而非使用注射用疾病修正药物相关的因素。

Factors associated with oral fingolimod use over injectable disease- modifying agent use in multiple sclerosis.

作者信息

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

机构信息

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

Baylor College of Medicine, Houston, TX, USA.

出版信息

Explor Res Clin Soc Pharm. 2021 May 5;2:100021. doi: 10.1016/j.rcsop.2021.100021. eCollection 2021 Jun.

Abstract

BACKGROUND

Fingolimod is the first approved oral disease-modifying agent (DMA) in 2010 to treat Multiple Sclerosis (MS). There is limited real-world evidence regarding the determinants associated with fingolimod use in the early years.

OBJECTIVE

The objective of this study was to examine the factors associated with fingolimod prescribing in the initial years after the market approval.

METHODS

A retrospective, longitudinal study was conducted involving adults (≥18 years) with MS from the 2010-2012 IBM MarketScan. Individuals with MS were selected based on ICD-9-CM: 340 and a newly initiated DMA prescription. Based on the index/first DMA prescription, patients were classified as fingolimod or injectable users. All covariates were measured during the six months baseline period prior to the index date. Multivariable logistic regression was performed to determine the predisposing, enabling, and need factors, conceptualized as per the Andersen Behavioral Model (ABM), associated with prescribing of fingolimod versus injectable DMA for MS.

RESULTS

The study cohort consisted of 3118 MS patients receiving DMA treatment. Of which, 14.4% of patients with MS initiated treatment with fingolimod within two years after the market entry, while the remaining 85.6% initiated with injectable DMAs. Multivariable regression revealed that the likelihood of prescribing oral DMA increased by 2-3 fold during 2011 and 2012 compared to 2010. Patients with ophthalmic (adjusted odds ratio [aOR]-2.60), heart (aOR-2.21) and urinary diseases (aOR-1.37) were more likely to receive fingolimod. Patients with other neurological disorders (aOR-0.50) were less likely to receive fingolimod than those without neurological disorders. Use of symptomatic medication (for impaired walking (aOR-2.60), bladder dysfunction (aOR-1.54), antispasmodics (aOR-1.48), and neurologist consultation (aOR-1.81) were associated with higher odds of receiving fingolimod. However, patients with non-MS associated emergency visits (aOR-0.64) had lower odds of receiving fingolimod than those without emergency visits.

CONCLUSIONS

During the initial years after market approval, patients with highly active MS were more likely to receive oral fingolimod than injectable DMAs. More research is needed to understand the determinants of newer oral DMAs.

摘要

背景

芬戈莫德是2010年首个获批用于治疗多发性硬化症(MS)的口服疾病修正药物(DMA)。关于早年与芬戈莫德使用相关的决定因素,实际证据有限。

目的

本研究的目的是探讨市场批准后最初几年中与芬戈莫德处方相关的因素。

方法

进行了一项回顾性纵向研究,纳入了2010 - 2012年IBM MarketScan数据库中年龄≥18岁的成年MS患者。根据ICD - 9 - CM编码340和新开具的DMA处方选择MS患者。根据索引/首张DMA处方,将患者分为使用芬戈莫德或注射用药的使用者。所有协变量均在索引日期前的六个月基线期内进行测量。采用多变量逻辑回归来确定与MS患者使用芬戈莫德而非注射用DMA处方相关的易感因素、促成因素和需求因素,这些因素是根据安德森行为模型(ABM)概念化的。

结果

研究队列包括3118例接受DMA治疗的MS患者。其中,14.4%的MS患者在市场准入后的两年内开始使用芬戈莫德治疗,其余85.6%的患者开始使用注射用DMA。多变量回归显示,与2010年相比,2011年和2012年开具口服DMA的可能性增加了2 - 3倍。患有眼科疾病(调整后的优势比[aOR]为2.60)、心脏病(aOR为2.21)和泌尿系统疾病(aOR为1.37)的患者更有可能接受芬戈莫德治疗。患有其他神经系统疾病的患者(aOR为0.50)比没有神经系统疾病的患者接受芬戈莫德治疗的可能性更小。使用对症药物(用于行走障碍[aOR为2.60]、膀胱功能障碍[aOR为1.54]、解痉药[aOR为1.48])以及接受神经科医生会诊(aOR为1.81)与接受芬戈莫德治疗的较高几率相关。然而,有非MS相关急诊就诊的患者(aOR为0.64)比没有急诊就诊的患者接受芬戈莫德治疗的几率更低。

结论

在市场批准后的最初几年,高度活跃的MS患者比使用注射用DMA的患者更有可能接受口服芬戈莫德治疗。需要更多研究来了解新型口服DMA的决定因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba25/9031432/d52dc8c2d2ef/gr1.jpg

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