BACKGROUND Multiple sclerosis (MS) is an autoimmune, neuroinflammatory, and neurodegenerative disease of the central nervous system. B cells have recently emerged as a promising target to significantly reduce inflammatory disease activity in MS, with successful trial studies using antiCD20 therapies. However, real-life data about safety and efficacy are limited. OBJECTIVES To analyze the clinical and radiological inflammatory activity, adherence to therapy, and safety of rituximab (RTX) in an MS patients' sample, treated from 2015 to 2018 in our center PATIENTS AND METHODS: Retrospective study on prospectively collected data about relapses, disability progression, and radiological activity (new T2 lesions and Gd-enhancing lesions) were recorded and used to assess no evidence of disease activity (NEDA) at 12 months. RTX-related adverse events were recorded. RTX was administered intravenously at a dosage of 1000 mg twice 2 weeks apart, then every 6 months. RESULTS Sixty-nine patients were included. Fifty-three (76.8%) had a relapsing-remitting, two a primary progressive course, and 14 a secondary progressive course. The mean follow-up period was 16 ± 9.7 months. Thirty-five (50.7%) patients had relapses in the year prior to RTX therapy, with a mean annualized relapse rate of 0.75, significantly reduced to 0.36 at 12 months (p < 0.001). Among the 36 patients included in the study who had an MRI available at 12 months, MRI activity was reduced from 88% (n = 32) to 8.3% (n = 3) at follow-up (p < 0.001). Twelve (17.4%) patients suspended RTX during the study. CONCLUSIONS Our real-life experience confirms that off-label therapy with RTX may represent a valid, cost-effective therapeutic option in MS.

中文翻译：

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在多发性硬化症患者的真实样本中接受利妥昔单抗治疗的经验。

背景技术多发性硬化症（MS）是中枢神经系统的自身免疫性，神经炎性和神经退行性疾病。最近，利用抗CD20治疗的成功试验研究表明，B细胞已成为有望显着降低MS炎症性疾病活动的靶标。但是，关于安全性和功效的现实生活数据有限。目的分析我们中心2015年至2018年治疗的MS患者样本中利妥昔单抗（RTX）的临床和放射学炎症活性，治疗依从性和安全性。患者与方法：回顾性研究前瞻性收集的复发，残疾数据记录病情发展和放射活动（新的T2病变和Gd增强病变），并用于评估12个月时没有疾病活动（NEDA）的证据。记录与RTX相关的不良事件。RTX以1000 mg的剂量静脉给药，间隔2周两次，然后每6个月一次。结果纳入69例患者。有53个（76.8％）的成绩有所缓解，有2个为初级进步课程，有14个为中等进步课程。平均随访期为16±9.7个月。RTX治疗前一年中有35名（50.7％）患者复发，平均年复发率为0.75，在12个月时显着降低至0.36（p <0.001）。在研究中包括的36例患者中，在12个月时可获得MRI的患者中，随访时MRI活性从88％（n = 32）降低至8.3％（n = 3）（p <0.001）。在研究期间，有十二名（17.4％）患者暂停了RTX。