Rocky Mountain Multiple Sclerosis Center at Anschutz Medical Campus, University of Colorado, Denver, CO, United States.
Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, United States.
J Neurol Sci. 2019 Dec 15;407:116498. doi: 10.1016/j.jns.2019.116498. Epub 2019 Oct 15.
Dimethyl fumarate (DMF) and fingolimod (FTY) are approved oral disease modifying therapies (DMTs) for relapsing multiple sclerosis (MS). There are currently no known head-to-head studies comparing DMF and FTY over 36 months, which leaves their relative effectiveness unknown.
To assess real-world discontinuation, effectiveness, and switching practices of DMF and FTY over 36 months along with disease activity after switching DMT.
Patients prescribed DMF (n = 737) and FTY (n = 535) from two academic MS centers were retrospectively reviewed. Discontinuation and effectiveness outcomes were assessed using propensity score (PS) weighting. PS model covariates included sociodemographics and clinical and MRI characteristics.
Discontinuation was more common in DMF (58.3%) versus FTY (45.2%) over 36 months [OR = 1.81, 95% CI (1.41-2.31), p < .001], largely driven by intolerance [OR = 1.63, 95% CI (1.18-1.73), p < .001]. There were no differences in clinical relapses [OR = 1.27, 95% CI (0.90-1.79), p = .17], gadolinium-enhancing (GdE) lesions [OR = 1.25, 95% CI (0.85-1.84), p = .26], or new T2-hyperintense lesions [OR = 0.99, 95% CI (0.74-1.32), p = .93]. Within 12 months of DMF/FTY discontinuation, switchers to highly effective therapy (HET) versus other DMTs (injectables/orals) had fewer relapses (DMF/HET, 5.9% versus DMF/Other, 14.2%, p = .03; FTY/HET, 11.6% versus FTY/Other, 18.0%, p = .04) and fewer GdE lesions post-FTY (DMF/HET, 10.3% versus DMF/Other, 14.3%, p = .36; FTY/HET, 11.9% versus FTY/Other, 21.5%, p = .04).
This combined analysis showed similar effectiveness for DMF and FTY over 36 months with higher DMF discontinuations. Disease activity was lower in switchers to HET versus injectable/oral therapies after DMF/FTY cessation.
富马酸二甲酯(DMF)和芬戈莫德(FTY)是批准用于治疗复发型多发性硬化症(MS)的口服疾病修正疗法(DMT)。目前尚无已知的头对头研究比较 DMF 和 FTY 在 36 个月内的疗效,因此它们的相对疗效尚不清楚。
评估 DMF 和 FTY 在 36 个月内的停药、疗效和转换实践,以及转换 DMT 后的疾病活动情况。
对来自两个学术 MS 中心的 737 名接受 DMF 治疗和 535 名接受 FTY 治疗的患者进行回顾性分析。使用倾向评分(PS)加权评估停药和疗效结局。PS 模型协变量包括社会人口统计学特征以及临床和 MRI 特征。
在 36 个月内,DMF 的停药率(58.3%)明显高于 FTY(45.2%)[OR=1.81,95%CI(1.41-2.31),p<0.001],主要是由于不耐受[OR=1.63,95%CI(1.18-1.73),p<0.001]。两组之间临床复发[OR=1.27,95%CI(0.90-1.79),p=0.17]、钆增强(GdE)病变[OR=1.25,95%CI(0.85-1.84),p=0.26]或新的 T2 高信号病变[OR=0.99,95%CI(0.74-1.32),p=0.93]并无差异。在 DMF/FTY 停药后 12 个月内,转换为高效治疗(HET)与转换为其他 DMT(注射或口服)的患者复发率更低(DMF/HET,5.9%,DMF/其他,14.2%,p=0.03;FTY/HET,11.6%,FTY/其他,18.0%,p=0.04),且在转换为 FTY 后 GdE 病变更少(DMF/HET,10.3%,DMF/其他,14.3%,p=0.36;FTY/HET,11.9%,FTY/其他,21.5%,p=0.04)。
这项综合分析显示,DMF 和 FTY 在 36 个月内的疗效相似,DMF 的停药率更高。与 DMF/FTY 停药后转换为注射或口服治疗的患者相比,转换为 HET 的患者疾病活动度更低。