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多发性硬化症治疗中干扰素依从性的影响:一项非实验性、回顾性、队列研究。

Impact of adherence to interferons in the treatment of multiple sclerosis: a non-experimental, retrospective, cohort study.

机构信息

Accredo Health Group, Inc., The University of Memphis, Memphis, Tennessee, USA.

出版信息

Clin Drug Investig. 2010;30(2):89-100. doi: 10.2165/11533330-000000000-00000.

Abstract

BACKGROUND

Relapsing-remitting multiple sclerosis (RRMS) is a chronic disease affecting about 400 000 people in the US characterized by increasing patient disability and burden on society. While there is no cure for multiple sclerosis (MS), pharmaceutical treatments exist that can limit the number of relapses a patient experiences, and slow disease progression. One such class of agents used to treat RRMS are the interferons: interferon-beta-1a (Rebif and Avonex and interferon-beta-1b (Betaseron and Extavia). Patients must take these injectable medications regularly to achieve the optimal outcomes. However, patient issues and potential adverse effects of the medication may prevent the patient from taking the medication as directed and lower adherence. To date, limited evidence exists regarding the effect of patient adherence to interferon-beta therapies on clinical and economic outcomes.

OBJECTIVE

The purpose of this study was to explore the impact of patient adherence to interferon-beta therapy on MS relapse rates and healthcare resource utilization.

METHODS

Using a non-experimental, retrospective cohort design, a sample population (n = 1606) was drawn from patients identified in a database that includes both pharmacy and medical claims data. The study population was separated into two groups based on a measure of medication possession ratio (MPR)-adherent and non-adherent patients, and adherence was defined as MPR > or =85% in a given year during the study period (2006-8). Key outcome variables included MS relapses and healthcare resource utilization. Data were analysed using parametric and non-parametric statistics, and regression modeling.

RESULTS

During the study period, the average MPR for all patients on interferon-beta therapy varied from 72% to 76%. Only 27-41% of patients in each year were considered adherent (i.e. MPR > or =85%) and only 4% of patients had an MPR of > or =85% throughout the 3-year study period (2006-8). Patients who were adherent tended to have a lower risk of relapses over 3 years than non-adherent patients. A significantly lower risk of relapses was found in 2006 (risk ratio [RR] 0.89; 95% CI 0.81, 0.97). Furthermore, an increasingly larger effect emerged between adherence and relapses when comparing adherent patients (MPR > or =85%) with subgroups of non-adherent patients (<80%, <75%, <70%, <65% and <60%). The impact of adherence on emergency room (ER) visits also tended to suggest a lower risk during 2006, 2007 and 2006-8. During 2008, the risk for an ER visit was significantly lower for patients adherent in 2007 (RR 0.78; 95% CI 0.61, 0.99). Inpatient admissions followed the ER trends, as patients considered adherent in 2006 and 2007 tended to have a lower risk over 3 years. This result was significant for patients adherent in 2007 (RR 0.79; 95% CI 0.65, 0.98).

CONCLUSION

The findings of low patient adherence and the impact of adherence on relapses and healthcare resource utilization strongly suggest opportunities to reduce healthcare resource utilization and healthcare costs among RRMS patients taking interferon-beta therapy. Efforts should be undertaken to understand and improve medication-taking behaviour in this population so as to minimize the negative impacts of RRMS on patients while reducing unnecessary direct and indirect costs to treat disease exacerbations.

摘要

背景

复发性缓解型多发性硬化症(RRMS)是一种影响美国约 40 万人的慢性疾病,其特征是患者残疾程度不断增加,给社会带来负担。虽然多发性硬化症(MS)目前无法治愈,但存在可以限制患者经历复发次数、减缓疾病进展的药物治疗方法。用于治疗 RRMS 的一类药物是干扰素:干扰素-β-1a(Rebif 和 Avonex)和干扰素-β-1b(Betaseron 和 Extavia)。患者必须定期使用这些注射药物以达到最佳效果。但是,患者问题和药物的潜在不良反应可能会导致患者无法按规定服药,从而降低了药物的依从性。迄今为止,关于患者对干扰素-β治疗的依从性对临床和经济结果的影响的证据有限。

目的

本研究旨在探讨患者对干扰素-β治疗的依从性对多发性硬化症复发率和医疗资源利用的影响。

方法

使用非实验性、回顾性队列设计,从包含药房和医疗索赔数据的数据库中抽取了一个样本人群(n=1606)。根据药物使用比例(MPR)的测量值,将研究人群分为两组——依从性和非依从性患者,在研究期间(2006-2008 年),将依从性定义为当年 MPR>或=85%。主要结局变量包括多发性硬化症复发和医疗资源利用。使用参数和非参数统计以及回归建模分析数据。

结果

在研究期间,所有接受干扰素-β治疗的患者的平均 MPR 从 72%到 76%不等。每年只有 27-41%的患者被认为是依从性(即 MPR>或=85%),并且只有 4%的患者在整个 3 年研究期间(2006-2008 年)的 MPR>或=85%。依从性较高的患者在 3 年内复发的风险较低。2006 年发现复发风险显著降低(风险比 [RR] 0.89;95%置信区间 [CI] 0.81, 0.97)。此外,当将依从性患者(MPR>或=85%)与非依从性患者(<80%、<75%、<70%、<65%和<60%)的亚组进行比较时,依从性与复发之间的相关性越来越大。依从性对急诊室(ER)就诊的影响也表明,2006 年、2007 年和 2006-2008 年期间风险较低。2008 年,2007 年依从性较好的患者急诊就诊风险显著降低(RR 0.78;95%CI 0.61, 0.99)。住院入院情况与急诊就诊趋势一致,因为 2006 年和 2007 年被认为是依从性较好的患者在 3 年内的风险较低。这一结果在 2007 年依从性较好的患者中是显著的(RR 0.79;95%CI 0.65, 0.98)。

结论

低患者依从性的发现以及依从性对复发和医疗资源利用的影响强烈表明,有机会减少接受干扰素-β治疗的 RRMS 患者的医疗资源利用和医疗成本。应努力了解和改善这一人群的服药行为,以尽量减少多发性硬化症对患者的负面影响,同时降低治疗疾病恶化的不必要的直接和间接成本。

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