Vieira Maria Cecilia, Li Yunfeng, Meng Xiangyi, Zhou Huanxue, Piao Olivia Wenxian, Kutz Christen, Conway Devon
Int J MS Care. 2021 Mar-Apr;23(2):73-78. doi: 10.7224/1537-2073.2019-050. Epub 2020 Apr 28.
Clinical and real-world studies have shown significant reductions in multiple sclerosis (MS) relapses with fingolimod versus injectable disease-modifying therapies (DMTs). Multiple sclerosis relapse rate and incidence were compared in patients switching from an injectable DMT to fingolimod and those cycling from one injectable DMT to another or remaining on their original injectable DMT.
Retrospective analysis was performed using Commercial and Medicare Supplemental claims data (July 1, 2010, to June 30, 2016) of adults with MS receiving ≥1 injectable DMT. Relapses were identified from MS-related hospitalization, outpatient emergency department or office visit, and corticosteroid administration. Annualized relapse rate ratio was estimated.
Of 16,352 patients, 1110 were switchers to fingolimod, 908 were injectable DMT cyclers, and 14,334 were nonswitchers. At baseline, rate and incidence of MS relapses were higher in switchers and injectable DMT cyclers versus nonswitchers ( < .001); mean ± SD relapse rates declined from 0.4 ± 0.7, 0.4 ± 0.7, and 0.2 ± 0.5 at baseline to 0.2 ± 0.5, 0.3 ± 0.6, and 0.1 ± 0.4 after follow-up in switchers, injectable DMT cyclers, and nonswitchers, respectively. Relapse incidence declined in each cohort. The highest reductions in relapse rate and incidence were in switchers to fingolimod, where relapse risk was significantly reduced versus injectable DMT cyclers (22%, = .0433) and nonswitchers (47%, < .001).
This study provides evidence that patients switching from an injectable DMT to fingolimod have the highest reductions in annualized rate and incidence of MS relapses and significantly reduced risk of relapse versus injectable DMT cyclers and nonswitchers.
临床研究和真实世界研究表明,与注射用疾病修正治疗药物(DMT)相比,芬戈莫德可显著降低多发性硬化症(MS)的复发率。对从注射用DMT转换为芬戈莫德的患者以及从一种注射用DMT转换为另一种注射用DMT或继续使用原注射用DMT的患者的多发性硬化症复发率和发病率进行了比较。
利用2010年7月1日至2016年6月30日期间接受≥1种注射用DMT的成年MS患者的商业保险和医疗保险补充理赔数据进行回顾性分析。从与MS相关的住院、门诊急诊科就诊或办公室就诊以及皮质类固醇给药情况中识别复发事件。估计年化复发率比值。
在16352例患者中,1110例转换为芬戈莫德,908例为注射用DMT转换者,14334例为未转换者。在基线时,转换者和注射用DMT转换者的MS复发率和发病率高于未转换者(P<0.001);转换者、注射用DMT转换者和未转换者的平均±标准差复发率从基线时的0.4±0.7、0.4±0.7和0.2±0.5分别降至随访后的0.2±0.5、0.3±0.6和0.1±0.4。每个队列的复发发病率均下降。复发率和发病率下降幅度最大的是转换为芬戈莫德的患者,其复发风险与注射用DMT转换者相比显著降低(22%,P=0.0433),与未转换者相比降低47%(P<0.001)。
本研究提供的证据表明,从注射用DMT转换为芬戈莫德的患者年化复发率和MS复发发病率降低幅度最大,与注射用DMT转换者和未转换者相比,复发风险显著降低。