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多发性硬化症患者皮下注射干扰素β-1a每周三次治疗中断的原因:一项真实世界队列研究

Reasons for discontinuation of subcutaneous interferon β-1a three times a week among patients with multiple sclerosis: a real-world cohort study.

作者信息

Sabidó-Espin Meritxell, Munschauer Rick

机构信息

, Frankfurter Str. 250, HPC: F135/201, Darmstadt, 64293, Germany.

EMD Serono, Rockland, MA, USA.

出版信息

BMC Neurol. 2017 Mar 23;17(1):57. doi: 10.1186/s12883-017-0831-4.

Abstract

BACKGROUND

Continuation of interferon (IFN) β-based therapies is important for maximum treatment effectiveness in patients with multiple sclerosis (MS); however, few real-world data are available on discontinuation from IFN β. The aim of this cohort analysis was to estimate real-world discontinuation rates up to 3 years among MS patients in the United States taking subcutaneous (sc) IFN β-1a three times a week (tiw) and to identify whether the factors associated with discontinuation change over time.

METHODS

Patient data were pooled from the MarketScan Commercial and Medicare Supplemental healthcare claims databases. Patients with ≥1 multiple sclerosis diagnosis who were sc IFN β-1a tiw naïve, had ≥1 year of continuous eligibility before treatment, and ≥1 prescription were followed from first prescription (index date) until date of discontinuation, switch, or end of observation. Treatment status was analysed at exactly 1, 2 or 3 years after index. Multivariable models were used to identify drivers of discontinuation.

RESULTS

Data from 5956 patients were included; 2862 patients (48.1%) discontinued therapy. Discontinuation rates were 36.9% (1 year), 49.5% (2 years) and 55.8% (3 years). A greater proportion of discontinuing patients had poor adherence (<80% [94.0%] versus ≥80% [51.7%]) or were taking additional medication at follow-up versus the overall population. Factors independently associated with discontinuation irrespective of time on therapy were increasing number of magnetic resonance imaging scans (1 year adjusted odds ratio 1.45, 95% confidence interval 1.26-1.67; 2 years 1.18, 1.06-1.32; 3 years 1.20, 1.07-1.34) and adherence <80% versus ≥80% (1 year 180.95, 135.84-241.03; 2 years 135.80, 100.10-184.23; 3 years 174.89, 115.27-265.38). Factors associated only with early discontinuation (at 1 year) were ≥3 sets of laboratory investigations versus none (2.54, 1.20-5.38), and anxiolytic use at follow-up (1.40, 1.06-1.82). Factors associated only with later discontinuation (at 2 years and/or at 3 years) were antidepressant use at follow-up (2 years 1.46, 1.10-1.94) and greater number of relapses (2 years 1.60, 1.11-2.30; 3 years 2.31, 1.27-4.22).

CONCLUSIONS

Potential drivers of discontinuation change over time. Improved awareness of the drivers of discontinuation could lead to targeted interventions to improve adherence.

摘要

背景

对于多发性硬化症(MS)患者,持续使用基于干扰素(IFN)β的疗法对于实现最大治疗效果至关重要;然而,关于停用IFNβ的真实世界数据却很少。这项队列分析的目的是估计美国每周三次皮下注射(sc)IFNβ-1a的MS患者在3年内的真实世界停药率,并确定与停药相关的因素是否随时间变化。

方法

患者数据来自MarketScan商业和医疗保险补充医疗索赔数据库。将初次使用sc IFNβ-1a tiw、治疗前连续资格≥1年且有≥1份处方的≥1次多发性硬化症诊断患者从首次处方(索引日期)随访至停药、换药或观察结束日期。在索引日期后的1、2或3年时分析治疗状态。使用多变量模型确定停药的驱动因素。

结果

纳入了5956例患者的数据;2862例患者(48.1%)停止治疗。停药率分别为36.9%(1年)、49.5%(2年)和55.8%(3年)。与总体人群相比,停药患者中依从性差(<80%[94.0%]对≥80%[51.7%])或随访时使用额外药物的比例更高。无论治疗时间长短,与停药独立相关的因素包括磁共振成像扫描次数增加(1年调整优势比1.45,95%置信区间1.26 - 1.67;2年1.18,1.06 - 1.32;3年1.20,1.07 - 1.34)以及依从性<80%对≥80%(1年180.95,135.84 - 241.03;2年135.80,100.10 - 184.23;3年174.89,115.27 - 265.38)。仅与早期停药(1年时)相关的因素包括≥3组实验室检查对无(2.54,1.20 - 5.38)以及随访时使用抗焦虑药(1.40,1.06 - 1.82)。仅与后期停药(2年和/或3年时)相关的因素包括随访时使用抗抑郁药(2年1.46,1.10 - 1.94)以及复发次数更多(2年1.60,1.11 - 2.30;3年2.31,1.27 - 4.22)。

结论

停药的潜在驱动因素随时间变化。提高对停药驱动因素的认识可能会带来有针对性的干预措施以提高依从性。

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