Instituto de Neurociencias de Rosario, Rosario, Argentina.
Centro de esclerosis múltiple de Buenos Aires, CABA, Argentina.
Clin Neuropharmacol. 2024;47(4):120-127. doi: 10.1097/WNF.0000000000000598. Epub 2024 May 22.
The aim was to evaluate patient profiles, effectiveness and safety of cladribine (CLAD) in patients with relapsing-remitting multiple sclerosis in Argentina.
This was a substudy included in RelevarEM (MS and neuromyelitis optica registry in Argentina, NCT03375177). Patients with MS who received CLAD tablets and were followed up for at least 24 months were included. Clinical evaluations every 3 months collect information about: a) clinical relapses; b) progression of physical disability, evaluated through Expanded Disability Status Scale, and c) new lesions found in the magnetic resonance imaging. Lymphopenia was evaluated during the follow-up and defined as grade 1: absolute lymphocyte count (ALC) 800-999/μL; grade 2: ALC 500-799/μL; grade 3: ALC 200-499/μL and grade 4: ALC <200/μL.
A total of 240 patients were included from 19 centers from Argentina. The mean annualized relapse rate during the 12-month pre-CLAD initiation was 1.19 ± 0.56 versus 0.22 ± 0.18 at month 12 and 0.19 ± 0.15 at month 24 ( P < 0.001). A total of 142 (59.2%) fulfilled the criteria of disease activity during the 12 months before treatment initiation, whereas 27 (11.3%) fulfilled it at month 12 and 38 (15.8%) at month 24, P < 0.001. Regarding no evidence of disease activity (NEDA), 202 (84.2%) patients achieved NEDA status at month 12 and 185 (77%) at month 24. The most frequent incidence density of lymphopenia for course 2 observed was also for grade 1, 6.1 (95% confidence interval [CI] = 5.5-7.1). The overall incidence density of lymphopenia grade 4 was 0.1 (95% CI = 0.06-0.19).
This information will help when choosing the best treatment option for Argentinean patients.
评估在阿根廷复发性多发性硬化症患者中使用克拉屈滨（CLAD）的患者特征、疗效和安全性。
这是 RelevarEM（阿根廷多发性硬化症和视神经脊髓炎登记处，NCT03375177）中的一项子研究。纳入接受 CLAD 片并至少随访 24 个月的多发性硬化症患者。每 3 个月进行一次临床评估，收集以下信息：a）临床复发；b）通过扩展残疾状况量表评估的身体残疾进展；c）磁共振成像中发现的新病变。在随访期间评估淋巴细胞减少症，并定义为 1 级：绝对淋巴细胞计数（ALC）800-999/μL；2 级：ALC 500-799/μL；3 级：ALC 200-499/μL；4 级：ALC <200/μL。
共纳入来自阿根廷 19 个中心的 240 名患者。在 CLAD 起始前的 12 个月内，平均年复发率为 1.19±0.56，而在 12 个月和 24 个月时分别为 0.22±0.18 和 0.19±0.15（P<0.001）。在治疗前的 12 个月内，共有 142 名（59.2%）患者符合疾病活动标准，而在 12 个月和 24 个月时分别有 27 名（11.3%）和 38 名（15.8%）患者符合疾病活动标准（P<0.001）。在无疾病活动（NEDA）方面，202 名（84.2%）患者在 12 个月时达到了 NEDA 状态，185 名（77%）患者在 24 个月时达到了 NEDA 状态。观察到的第 2 疗程中淋巴细胞减少症最常见的发生率密度也为 1 级，为 6.1（95%置信区间[CI]为 5.5-7.1）。淋巴细胞减少症 4 级的总发生率密度为 0.1（95%CI=0.06-0.19）。
这些信息将有助于为阿根廷患者选择最佳治疗方案。
