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起始用芬戈莫德与特立氟胺治疗多发性硬化的治疗失败时间:一项回顾性美国理赔研究。

Time to treatment failure following initiation of fingolimod versus teriflunomide for multiple sclerosis: a retrospective US claims study.

机构信息

Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.

出版信息

Curr Med Res Opin. 2020 Feb;36(2):261-270. doi: 10.1080/03007995.2019.1690440. Epub 2019 Dec 5.

Abstract

Disease modifying therapies (DMTs) for multiple sclerosis (MS) aim to delay progression and reduce relapses. Evidence is limited on the comparative effectiveness of the oral DMTs fingolimod and teriflunomide. This study evaluated time to treatment failure among patients with MS who initiated fingolimod versus teriflunomide in real-world settings. The retrospective cohort included 18-64 year old patients diagnosed with MS who initiated fingolimod or teriflunomide during 12 September 2012 to 30 September 2015 within MarketScan Commercial and Medicare Claims. Patients were followed from treatment initiation (index date) until first treatment failure or censoring. Treatment failure was defined as the first occurrence of MS relapse (identified using a validated algorithm) or treatment discontinuation (≥60 day supply gap). Treatment failure was examined through Kaplan-Meier analysis and multivariable Cox regression adjusting for 1 year baseline factors (age, gender, plan type, region, index year, prior DMT use, baseline relapses, Charlson Comorbidity Index [CCI] and MS symptoms). On average, patients treated with fingolimod ( = 2704) were younger (43.6 versus 49.8 years) with lower CCI (0.4 versus 0.7) and more relapses at baseline (0.46 versus 0.42) than those treated with teriflunomide ( = 1859). Median time to treatment failure was 19.5 months with fingolimod versus 9.6 months with teriflunomide ( < .001). After controlling key demographic and clinical characteristics through multivariable regression, fingolimod was associated with 38.9% lower hazards of treatment failure versus teriflunomide (adjusted hazard ratio = 0.611; 95% CI: 0.559-0.669;  < .001). In a large cohort of US adults with MS, controlling for key baseline characteristics, fingolimod was associated with significantly longer time to treatment failure and lower risk of treatment failure compared with teriflunomide.

摘要

用于多发性硬化症(MS)的疾病修正疗法(DMT)旨在延缓疾病进展和减少复发。在口服 DMT fingolimod 和 teriflunomide 的比较有效性方面,证据有限。本研究评估了在真实环境中,起始使用 fingolimod 与 teriflunomide 的 MS 患者之间的治疗失败时间。回顾性队列纳入了 2012 年 9 月 12 日至 2015 年 9 月 30 日期间在 MarketScan 商业和医疗保险索赔中诊断为 MS 并起始使用 fingolimod 或 teriflunomide 的 18-64 岁患者。患者从治疗开始(索引日期)起,随访至首次治疗失败或删失。治疗失败定义为 MS 复发(使用验证算法确定)或停药(≥60 天供应缺口)的首次发生。通过 Kaplan-Meier 分析和多变量 Cox 回归检查治疗失败,该回归调整了 1 年的基线因素(年龄、性别、计划类型、地区、索引年、既往 DMT 使用、基线复发、Charlson 合并症指数 [CCI] 和 MS 症状)。平均而言,起始使用 fingolimod 的患者( = 2704 人)比起始使用 teriflunomide的患者( = 1859 人)更年轻(43.6 岁 vs. 49.8 岁),CCI 较低(0.4 vs. 0.7),基线时复发更多(0.46 次 vs. 0.42 次)。起始使用 fingolimod 的中位治疗失败时间为 19.5 个月,起始使用 teriflunomide的中位治疗失败时间为 9.6 个月( < .001)。通过多变量回归控制关键人口统计学和临床特征后,fingolimod 与 teriflunomide 相比,治疗失败的风险降低了 38.9%(调整后的危险比=0.611;95%CI:0.559-0.669; < .001)。在一项大型美国 MS 成年患者队列中,在控制关键基线特征的情况下,与 teriflunomide 相比,fingolimod 与显著更长的治疗失败时间和更低的治疗失败风险相关。

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