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多发性硬化症患者从注射用疾病修正药物转换为口服药物的相关因素

FACTORS ASSOCIATED WITH SWITCHING FROM INJECTABLE TO ORAL DISEASE MODIFYING AGENTS AMONG PATIENTS WITH MULTIPLE SCLEROSIS.

作者信息

Li Jieni, Chikermane Soumya G, Earla Jagadeswara R, Hutton George J, Aparasu Rajender R

机构信息

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

Baylor College of Medicine, Houston, Texas.

出版信息

Mult Scler Relat Disord. 2022 Apr;60:103703. doi: 10.1016/j.msard.2022.103703. Epub 2022 Feb 26.

Abstract

BACKGROUND

Since the introduction of oral disease-modifying agents (DMA) in 2010, the treatment options for multiple sclerosis (MS) have changed significantly. There is limited information regarding the factors associated with switching to oral DMA among prevalent injectable DMA users.

OBJECTIVE

This study evaluated the factors associated with switching to oral DMAs among prevalent injectable DMA users with MS.

METHODS

A retrospective observational cohort study using the TriNetX electronic medical records (EMR) data was conducted among patients with MS. The study included prevalent injectable DMA users with at least two injectable DMA (interferon beta-1a, interferon beta-1b, peginterferon beta-1a, or glatiramer acetate) prescription records within 6 months between September 2010 and May 2018. The second injectable DMA prescription date was considered as the index date. Switching was defined as any oral DMA prescription record (fingolimod, dimethyl fumarate, or teriflunomide) within 12 months after the index date. Patients with any infusion DMA prescription after the first injectable DMA prescription, and those less than 18 years of age were excluded from the study. The Andersen Behavioral Model was used as the conceptual framework to identify predisposing, enabling, and need factors measured during the 1-year baseline period before the index date. A multivariable logistic regression model was used to examine the predisposing (age, sex, race, and ethnicity), enabling (time-period), and need factors (comorbidities, MS symptoms, MS-related medication, and healthcare utilization) associated with switching from injectable to oral DMAs.

RESULTS

Among 2,943 prevalent injectable users included in this study, 8.09% (n=238) patients switched to oral DMAs. Patients who switched to oral DMAs were primarily younger adults aged 18-44 years (64.29%), females (82.77%), had sensory and visual symptoms, and had corticosteroid utilization during the one-year look-back period compared to non-switchers. Results from multivariable logistic regression model revealed that middle-aged adults (45-64 years, adjusted odds ratio [aOR]: 0.43, 95% Confidence Interval [CI]: 0.32-0.58), old adults (≥65 years, aOR: 0.30, 95% CI: 0.13-0.66) and men (aOR: 0.67, 95% CI: 0.47-0.96) were associated with decreased odds of switching to oral DMAs. Presence of MS-related sensory symptoms (aOR: 1.52, 95% CI: 1.07-2.16), visual symptoms (aOR: 1.59, 95% CI: 1.10-2.31), and corticosteroids usage (aOR: 1.44, 95% CI: 1.04-1.98) were associated with increased odds of switching to oral DMAs.

CONCLUSION

The study found that about one in twelve prevalent injectable DMA users switched to oral DMA. Both demographic and clinical factors were associated with switching to oral DMAs. Further research is needed to evaluate the outcomes of switching to inform treatment decisions for MS management.

摘要

背景

自2010年引入口服疾病修正药物(DMA)以来,多发性硬化症(MS)的治疗选择发生了显著变化。关于现有注射用DMA使用者转向口服DMA的相关因素的信息有限。

目的

本研究评估了现有MS注射用DMA使用者转向口服DMA的相关因素。

方法

利用TriNetX电子病历(EMR)数据对MS患者进行了一项回顾性观察队列研究。该研究纳入了在2010年9月至2018年5月的6个月内至少有两条注射用DMA(干扰素β-1a、干扰素β-1b、聚乙二醇干扰素β-1a或醋酸格拉替雷)处方记录的现有注射用DMA使用者。第二条注射用DMA处方日期被视为索引日期。转向定义为在索引日期后12个月内的任何口服DMA处方记录(芬戈莫德、富马酸二甲酯或特立氟胺)。在首次注射用DMA处方后有任何输液DMA处方的患者以及年龄小于18岁的患者被排除在研究之外。采用安德森行为模型作为概念框架,以识别在索引日期前1年基线期测量的易患因素、促成因素和需求因素。使用多变量逻辑回归模型来检验与从注射用DMA转向口服DMA相关的易患因素(年龄、性别、种族和民族)、促成因素(时间段)和需求因素(合并症、MS症状、MS相关药物和医疗保健利用)。

结果

在本研究纳入的2943名现有注射用使用者中,8.09%(n = 238)的患者转向了口服DMA。与未转向者相比,转向口服DMA的患者主要是18 - 44岁的年轻成年人(64.29%)、女性(82.77%),有感觉和视觉症状,并且在一年回顾期内使用过皮质类固醇。多变量逻辑回归模型的结果显示,中年成年人(45 - 64岁,调整后的优势比[aOR]:0.43,95%置信区间[CI]:0.32 - 0.58)、老年人(≥65岁,aOR:0.30,95% CI:0.13 - 0.66)和男性(aOR:0.67,95% CI:0.47 - 0.96)转向口服DMA的几率降低。存在MS相关的感觉症状(aOR:1.52,95% CI:1.07 - 2.16)、视觉症状(aOR:1.59,95% CI:1.10 - 2.31)和皮质类固醇的使用(aOR:1.44,95% CI:1.04 - 1.98)与转向口服DMA的几率增加相关。

结论

该研究发现,约十二分之一的现有注射用DMA使用者转向了口服DMA。人口统计学和临床因素均与转向口服DMA相关。需要进一步研究以评估转向的结果,为MS管理的治疗决策提供信息。

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