Hersh Carrie M, Love Thomas E, Bandyopadhyay Anasua, Cohn Samuel, Hara-Cleaver Claire, Bermel Robert A, Fox Robert J, Cohen Jeffrey A, Ontaneda Daniel
Lou Ruvo Center for Brain Health, Cleveland Clinic, USA.
Departments of Medicine and Epidemiology and Biostatistics, Case Western Reserve University, USA.
Mult Scler J Exp Transl Clin. 2017 Aug 24;3(3):2055217317715485. doi: 10.1177/2055217317715485. eCollection 2017 Jul-Sep.
Dimethyl fumarate and fingolimod are oral disease-modifying therapies approved to treat relapsing multiple sclerosis. Prior observational studies and our previous 12-month investigation showed comparable clinical efficacy.
The purpose of this study was to assess real-world efficacy and discontinuation of dimethyl fumarate and fingolimod over 24 months in patients with multiple sclerosis.
Patients treated with dimethyl fumarate ( = 395) or fingolimod ( = 264) completed 24-month follow-up in a large academic multiple sclerosis center. Discontinuation rates and measures of disease activity were compared after propensity score weighting. The primary outcome was on-treatment annualized relapse rate ratio. Other measures included rate of drug discontinuation and brain magnetic resonance imaging activity defined as new T2 and/or gadolinium-enhancing lesions.
Propensity score weighting showed excellent covariate balance. At 24 months, dimethyl fumarate demonstrated comparable annualized relapse rate (rate ratio = 1.45, 95% confidence interval 0.53-3.99) and brain magnetic resonance imaging activity (odds ratio = 1.38, 95% confidence interval 0.83-2.32). Dimethyl fumarate patients discontinued therapy earlier compared to fingolimod (hazard ratio = 1.40, 95% confidence interval 1.11-1.77) and were more likely to discontinue therapy due to intolerability (odds ratio = 1.98, 95% confidence interval 1.18-3.23).
Dimethyl fumarate and fingolimod had similar reductions in annualized relapse rate in clinical trials, and our real-world experience supports this observation. Dimethyl fumarate-treated patients had higher likelihood of early discontinuation, and this was mostly due to intolerability.
富马酸二甲酯和芬戈莫德是被批准用于治疗复发型多发性硬化症的口服疾病修正疗法。先前的观察性研究以及我们之前为期12个月的调查显示了相当的临床疗效。
本研究的目的是评估富马酸二甲酯和芬戈莫德在多发性硬化症患者中24个月的实际疗效和停药情况。
在一个大型学术性多发性硬化症中心，接受富马酸二甲酯（n = 395）或芬戈莫德（n = 264）治疗的患者完成了24个月的随访。在倾向评分加权后比较停药率和疾病活动度指标。主要结局是治疗期间的年化复发率比值。其他指标包括药物停药率以及定义为新的T2和/或钆增强病灶的脑磁共振成像活动度。
倾向评分加权显示出良好的协变量平衡。在24个月时，富马酸二甲酯显示出相当的年化复发率（率比 = 1.45，95%置信区间0.53 - 3.99）和脑磁共振成像活动度（优势比 = 1.38，95%置信区间0.83 - 2.32）。与芬戈莫德相比，富马酸二甲酯治疗的患者更早停药（风险比 = 1.40，95%置信区间1.11 - 1.77），并且更有可能因不耐受而停药（优势比 = 1.98，95%置信区间1.18 - 3.23）。
在临床试验中，富马酸二甲酯和芬戈莫德在年化复发率降低方面相似，我们的实际经验支持这一观察结果。接受富马酸二甲酯治疗的患者早期停药的可能性更高，这主要是由于不耐受。
