Centro de Esclerosis Múltiple de Buenos Aires (CEMBA), Billinghurst 1611, Buenos Aires CP 1181, Argentina.
Unidad de Neuroinmunología, Servicio de Neurología, Hospital Alemán de Buenos Aires, Argentina.
Mult Scler Relat Disord. 2024 May;85:105543. doi: 10.1016/j.msard.2024.105543. Epub 2024 Mar 16.
The objective of this study was to describe and compare the burden of treatment (BOT) and the quality of life (QoL) in early high efficacy therapy (HET) vs. escalation therapy in relapsing remitting multiple sclerosis (RRMS) patients included in RelevarEM, the Argentinean registry of MS (RelevarEM, NCT 03,375,177).
cross sectional study conducted between September and December 2022. Participating patients were adults, RRMS patients who initiated (during the last three years) their treatment with a HET (natalizumab, ocrelizumab, alemtuzumab, cladribine) or with escalation treatment (beta interferon, glatiramer acetate, teriflunomide, dimethyl fumarate or fingolimod). Clinical and demographic aspect were collected. QoL and BOT was measured with the validated to Spanish MusiQol and BOT questionnaire. Propensity score (PS)-based nearest-neighbor matching was applied to homogenize groups. Comparisons were be done using a linear regression analysis model stratified by matched pairs, with BOT and QoL assessments as main outcomes.
269 patients were included in the analysis, mean age 33.7 ± 5.7 years, 193 (71.7 %) were female. A total of 136 patients were on early HET while 133 were on escalation therapy. In the entire group the mean total BOT score (±SD) was 48.5 ± 15.3 while in the group of patients receiving early HET we observed that the mean BOT score (±SD) was 43.5 ± 12.2 vs. 54.3 ± 13.3 in escalation treatment (p < 0.0001). Regarding the score QoL (±SD), in the entire sample we observed a global score of 77.4 ± 11.2. When we stratified groups, in HET (±SD) it was 81.3 ± 14 vs. 74.1 ± 18.3 in escalation therapy (p = 0.0003).
in this multicenter study that included 269 patients from Argentina we observed in early HET a significantly lower BOT and higher QoL than patients receiving escalation therapy.
本研究旨在描述和比较早期高效治疗(HET)与复发缓解型多发性硬化症(RRMS)患者中升级治疗的治疗负担(BOT)和生活质量(QoL),该研究纳入了阿根廷多发性硬化症登记处(RelevarEM,NCT 03,375,177)。
这是一项在 2022 年 9 月至 12 月期间进行的横断面研究。纳入的患者为成年人,RRMS 患者,他们在过去三年中开始接受 HET(那他珠单抗、奥瑞珠单抗、阿仑单抗、克拉屈滨)或升级治疗(β干扰素、聚乙二醇干扰素、特立氟胺、富马酸二甲酯或芬戈莫德)。收集临床和人口统计学方面的数据。使用经过验证的西班牙语版 MusiQol 和 BOT 问卷来评估 QoL 和 BOT。应用倾向评分(PS)最近邻匹配来使组间同质化。使用基于匹配对的线性回归分析模型进行比较,以 BOT 和 QoL 评估为主要结局。
共纳入 269 例患者进行分析,平均年龄为 33.7±5.7 岁,193 例(71.7%)为女性。共有 136 例患者接受早期 HET,133 例患者接受升级治疗。在整个组中,总 BOT 评分(±SD)的平均值为 48.5±15.3,而在接受早期 HET 的患者组中,我们观察到 BOT 评分(±SD)的平均值为 43.5±12.2 与升级治疗组的 54.3±13.3 相比(p<0.0001)。关于 QoL 评分(±SD),在整个样本中,我们观察到全球评分 77.4±11.2。当我们对组进行分层时,在 HET(±SD)中,它为 81.3±14 与升级治疗组的 74.1±18.3 相比(p=0.0003)。
在这项包括来自阿根廷的 269 例患者的多中心研究中,我们观察到早期 HET 的 BOT 显著低于接受升级治疗的患者,而 QoL 则更高。