Ernst Frank R, Barr Peri, Elmor Riad, Wong Schiffon L
a Health Economics and Outcomes Research , Indegene, Inc. , Kennesaw , GA , USA.
b Global Evidence & Value Development, Global Research & Development , EMD Serono, Inc. , Billerica , MA , USA.
Curr Med Res Opin. 2017 Dec;33(12):2099-2106. doi: 10.1080/03007995.2017.1380616. Epub 2017 Sep 28.
To estimate real-world treatment patterns, safety, and relapse outcomes of subcutaneous (sc) interferon (IFN) β-1a (Rebif) vs dimethyl fumarate (DMF; Tecfidera), to treat relapsing-remitting multiple sclerosis (RRMS).
A US retrospective chart review of 450 randomly selected adults newly diagnosed with RRMS who received sc IFN β-1a (n = 143) or DMF (n = 307) was conducted. Patients were either (a) treatment-naïve, initiating first-line treatment with sc IFN β-1a or DMF, or (b) previously treated, switching to sc IFN β-1a or DMF. Two years' follow-up data were captured. Patient characteristics, persistence, and adverse events between treatment groups were compared using t-tests or Chi-square tests. Kaplan-Meier curves with log-rank tests and Cox proportional hazards models were used to compare time to, and risk of non-persistence. Annualized Relapse Rates (ARR) were calculated using a robust variance Poisson model adjusting for covariates. Propensity scores were used to address possible selection bias.
One hundred and twelve patients became non-persistent, most commonly due to an adverse event (n = 37). No difference was observed in time to overall non-persistence between sc IFN β-1a and DMF patients. Among treatment-naïve patients, those receiving DMF had 2.4-times the risk (HR = 2.439, 95% CI = 1.007-5.917, p = .0483) of experiencing a discontinuation than patients receiving sc IFN β-1a. Non-persistent patients receiving DMF had 2.3-times the risk (HR = 2.311, 95% CI = 1.350-3.958, p = .0023) of experiencing an adverse event at a given time point than patients prescribed sc IFN β-1a. No differences in relapse risk or ARR between sc IFN β-1a- and DMF-treated patients were observed.
sc IFN β-1a-treated patients had comparable persistence and relapse outcomes, and better safety outcomes vs DMF-treated patients across 2 years.
评估皮下注射干扰素β-1a（Rebif）与富马酸二甲酯（DMF；Tecfidera）治疗复发缓解型多发性硬化症（RRMS）的真实世界治疗模式、安全性及复发结局。
对450例随机选取的新诊断为RRMS的成年患者进行美国回顾性病历审查，这些患者接受皮下注射干扰素β-1a（n = 143）或DMF（n = 307）治疗。患者分为两类：（a）初治患者，开始使用皮下注射干扰素β-1a或DMF进行一线治疗；（b）既往接受过治疗，转而使用皮下注射干扰素β-1a或DMF。收集两年的随访数据。使用t检验或卡方检验比较治疗组之间的患者特征、持续治疗情况及不良事件。采用带有对数秩检验的Kaplan-Meier曲线和Cox比例风险模型比较达到非持续治疗的时间及非持续治疗风险。使用稳健方差泊松模型并调整协变量来计算年化复发率（ARR）。采用倾向得分法处理可能的选择偏倚。
112例患者未持续治疗，最常见原因是不良事件（n = 37）。皮下注射干扰素β-1a组和DMF组患者总体非持续治疗时间无差异。在初治患者中，接受DMF治疗的患者停药风险是接受皮下注射干扰素β-1a治疗患者的2.4倍（HR = 2.439，95%CI = 1.007 - 5.917，p = 0.0483）。在给定时间点，接受DMF治疗的非持续治疗患者发生不良事件的风险是接受皮下注射干扰素β-1a治疗患者的2.3倍（HR = 2.311，95%CI = 1.350 - 3.958，p = 0.0023）。皮下注射干扰素β-1a治疗组和DMF治疗组患者在复发风险或ARR方面未观察到差异。
在两年时间里，皮下注射干扰素β-1a治疗的患者与DMF治疗的患者相比，在持续治疗情况和复发结局方面相当，但安全性结局更好。
