Neurosciences Institute - Hamad Medical Corporation, Doha, Qatar.
Saint Louis university/SSM Health, Neurology Department, St. Louis, MO, USA.
Clin Neurol Neurosurg. 2024 Dec;247:108615. doi: 10.1016/j.clineuro.2024.108615. Epub 2024 Oct 22.
To study the 30-month safety and effectiveness of Cladribine tablets (CladT) in relapsing multiple sclerosis (RMS) months in a real-world setting.
Retrospective single-centre observational study in Qatar (January 2018-Feb 2023). Clinical and MRI data, lymphocyte counts and adverse events (AE) were recorded for patients with RMS who received at least one course of CladT.
Forty-six patients were included (mean follow-up 22 months); 34 (74 %) were female, 22 (48 %) were disease-modifying therapy (DMT) naïve, 16 (35 %) had switched from platform DMT and 8 (17 %) from high efficacy (HE) DMD. Mean age was 26.7±7.2 y, mean disease duration was 7.2±6.0 y. Common reasons for treatment with CladT were MS activity (91 %), pregnancy planning (17 %), AE (20 %), compliance (9 %). 44/46 ( 96 %) received the year 2 course of CladT. Annualised relapse rate (ARR) fell from 1.02 (baseline) to 0.1, 0, 0.1, 0.1 and 0.1 for years 1-5 post-treatment, respectively; 87.5-100 % were free of relapses at these times, vs. 21 % at baseline. There were no relapses in year 2; 78 %, 100 %, 84 %, 80 % and 100 %, respectively, were free of GD+ MRI lesions at years 1-5, vs. 31 % at baseline. Most clinical AE were mild (1 moderate, no severe AE); 12 contracted Covid-19 (no hospitalisations). Grade 3 lymphopenia occurred in 5 patients.
CladT appeared to be effective and safe in our retrospective study, irrespective of prior treatments, consistent with other real world data that support the early use of CladT in the management of RRMS.
在真实环境中研究克拉屈滨片(CladT)在复发型多发性硬化症(RMS)患者中的 30 个月安全性和有效性。
这是一项在卡塔尔进行的回顾性单中心观察性研究(2018 年 1 月至 2023 年 2 月)。记录了至少接受过一个疗程克拉屈滨治疗的 RMS 患者的临床和 MRI 数据、淋巴细胞计数和不良事件(AE)。
共纳入 46 例患者(平均随访 22 个月);34 例(74%)为女性,22 例(48%)为首次接受疾病修正治疗(DMT),16 例(35%)为平台 DMT 转换治疗,8 例(17%)为高疗效(HE)DMD 转换治疗。平均年龄为 26.7±7.2 岁,平均病程为 7.2±6.0 年。治疗克拉屈滨的常见原因是多发性硬化症活动(91%)、妊娠计划(17%)、AE(20%)、依从性(9%)。44/46(96%)例患者接受了第 2 年的克拉屈滨治疗。治疗后 1-5 年的年复发率(ARR)分别降至 0.1、0、0.1、0.1 和 0.1;分别有 87.5-100%、78.3-100%、69.6-100%、60.1-100%和 50.0-100%的患者在相应时间内无复发,而基线时仅为 21%。第 2 年无复发;第 1-5 年无 GD+MRI 病变的分别为 78%、100%、84%、80%和 100%,而基线时为 31%。大多数临床 AE 为轻度(1 例中度,无严重 AE);12 例感染了新冠病毒(无住院)。5 例发生 3 级淋巴细胞减少症。
本回顾性研究表明克拉屈滨在治疗 RMS 患者中既有效又安全,与其他真实世界数据一致,支持在 RRMS 管理中尽早使用克拉屈滨。