MSBase Foundation, Melbourne, VIC, Australia.
Dokuz Eylul University, Izmir, Turkey.
Mult Scler. 2023 Feb;29(2):221-235. doi: 10.1177/13524585221137502. Epub 2022 Nov 26.
Effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience.
Use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs.
Retrospective treatment comparisons were based on data from the international MSBase registry. Eligible pwMS started treatment with cladribine, fingolimod, dimethyl fumarate, or teriflunomide tablets from 2018 to mid-2021 and were censored at treatment discontinuation/switch, death, loss to follow-up, pregnancy, or study period end. Treatment persistence was evaluated as time to discontinuation/switch; relapse outcomes included time to first relapse and annualized relapse rate (ARR).
Cohorts included 633 pwMS receiving cladribine tablets, 1195 receiving fingolimod, 912 receiving dimethyl fumarate, and 735 receiving teriflunomide. Individuals treated with fingolimod, dimethyl fumarate, or teriflunomide switched treatment significantly more quickly than matched cladribine tablet cohorts (adjusted hazard ratio (95% confidence interval): 4.00 (2.54-6.32), 7.04 (4.16-11.93), and 6.52 (3.79-11.22), respectively). Cladribine tablet cohorts had significantly longer time-to-treatment discontinuation, time to first relapse, and lower ARR, compared with other oral DMT cohorts.
Cladribine tablets were associated with a significantly greater real-world treatment persistence and more favorable relapse outcomes than all oral DMT comparators.
克拉屈滨片是一种用于多发性硬化症(MS)的口服疾病修正治疗(DMT)药物,其疗效已在临床试验中得到证实,并得到了真实世界经验的验证。
利用真实世界数据比较接受克拉屈滨片与其他口服 DMT 治疗的 MS 患者(pwMS)的治疗模式和临床结局。
回顾性治疗比较基于国际 MSBase 登记处的数据。符合条件的 pwMS 于 2018 年至 2021 年年中期间开始接受克拉屈滨、芬戈利莫德、富马酸二甲酯或特立氟胺治疗,并在治疗停药/换药、死亡、失访、妊娠或研究期结束时进行了随访。治疗持续时间评估为停药/换药时间;复发结局包括首次复发时间和年复发率(ARR)。
队列包括 633 名接受克拉屈滨片治疗的 pwMS、1195 名接受芬戈利莫德治疗的 pwMS、912 名接受富马酸二甲酯治疗的 pwMS和 735 名接受特立氟胺治疗的 pwMS。与匹配的克拉屈滨片队列相比,接受芬戈利莫德、富马酸二甲酯或特立氟胺治疗的个体更快地更换了治疗方案(调整后的风险比(95%置信区间):4.00(2.54-6.32)、7.04(4.16-11.93)和 6.52(3.79-11.22))。与其他口服 DMT 队列相比,克拉屈滨片队列的治疗停药时间、首次复发时间更长,ARR 更低。
与所有口服 DMT 对照药物相比,克拉屈滨片治疗与显著更高的真实世界治疗持续时间和更有利的复发结局相关。