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评估阿根廷复发缓解型多发性硬化症患者中高效治疗药物(HETs)的使用情况。

Evaluation of the use of high-efficacy treatments (HETs) in patients with relapsing-remitting multiple sclerosis in Argentina.

机构信息

Centro Universitario de Esclerosis Múltiple, Hospital Ramos Mejía, Ciudad de Buenos Aires, Argentina; Servicio de Neurología, Sanatorio Güemes, Ciudad de Buenos Aires, Argentina.

Centro Universitario de Esclerosis Múltiple, Hospital Ramos Mejía, Ciudad de Buenos Aires, Argentina.

出版信息

Mult Scler Relat Disord. 2023 Nov;79:104935. doi: 10.1016/j.msard.2023.104935. Epub 2023 Aug 9.

Abstract

BACKGROUND

Disease-modifying therapies (DMTs) in multiple sclerosis (MS) can be classified according to the efficacy in which they prevent inflammatory activity. To date, there are limited data regarding the use of high-efficacy treatments (HETs) in Latin America (LATAM). We aimed to analyze the use of HETs in Argentina, focusing on the clinical and sociodemographic characteristics of the patients who use these treatments and the changes in the trend of use over the years.

METHODS

A retrospective cohort study was done using the Argentina MS patient registry, RelevarEM. Patients diagnosed with relapsing-remitting MS (RRMS) according to validated diagnostic criteria and under treatment with natalizumab, alemtuzumab, cladribine, rituximab or ocrelizumab were included.

RESULTS

Out of 2450 RRMS patients under a DMT, 462 (19%) were on HETs. One third of those patients (35%) received HETs as the first treatment. The most frequent reason for switching to HETs was treatment failure to previous DMT (77%). The time from MS diagnosis to the first HET in treatment-naive patients was less than one year (IQR: 0-1 year) and in treatment-experienced patients it was 5 years (IQR: 3-9 years). Between 2015 and 2017 (P1), 729 patients included in RelevarEM started a new treatment, of which 85 (11.65%) were HETs. Between 2018 and 2020 (P2), 961 patients included in RelevarEM started a new treatment, of which 284 (29.55%) were HETs. When comparing P2 with P1, a significant increase in the use of HETs was observed (p < 0.01). The most frequently used HETs were alemtuzumab (50.59%) in P1, and cladribine (45.20%) in P2.

CONCLUSION

The demographic and clinical characteristics of patients under HET in Argentina were identified. Based on a real-world setting, we found a significant trend towards and a rapid increase in the use of HETs in clinical practice in patients with RRMS.

摘要

背景

多发性硬化症(MS)的疾病修正疗法(DMT)可根据其预防炎症活性的疗效进行分类。迄今为止,关于拉丁美洲(LATAM)使用高效疗法(HET)的数据有限。我们旨在分析阿根廷使用 HET 的情况,重点关注使用这些治疗方法的患者的临床和社会人口统计学特征,以及多年来使用趋势的变化。

方法

我们使用阿根廷 MS 患者登记处 RelevarEM 进行了回顾性队列研究。符合经验证的诊断标准且正在接受那他珠单抗、阿仑单抗、克拉屈滨、利妥昔单抗或奥瑞珠单抗治疗的复发性缓解型 MS(RRMS)患者被纳入研究。

结果

在接受 DMT 的 2450 例 RRMS 患者中,有 462 例(19%)接受了 HET。这些患者中有三分之一(35%)接受 HET 作为一线治疗。转换为 HET 的最常见原因是先前 DMT 治疗失败(77%)。初治患者从 MS 诊断到首次接受 HET 的时间不到一年(IQR:0-1 年),而在治疗经验丰富的患者中为 5 年(IQR:3-9 年)。在 2015 年至 2017 年(P1)期间,纳入 RelevarEM 的 729 例患者开始了新的治疗,其中 85 例(11.65%)为 HET。在 2018 年至 2020 年(P2)期间,纳入 RelevarEM 的 961 例患者开始了新的治疗,其中 284 例(29.55%)为 HET。与 P1 相比,P2 中 HET 的使用显著增加(p < 0.01)。在 P1 中最常使用的 HET 是阿仑单抗(50.59%),而在 P2 中是克拉屈滨(45.20%)。

结论

确定了阿根廷接受 HET 治疗的患者的人口统计学和临床特征。基于真实世界的情况,我们发现 RRMS 患者在临床实践中使用 HET 的趋势显著且快速增加。

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