奥瑞珠单抗在多发性硬化症中的真实世界研究：科威特经验。
Real world study of ocrelizumab in multiple sclerosis: Kuwait experience.
机构信息
Division of Neurology, Amiri Hospital, Arabian Gulf Street, Sharq 13041, Kuwait; MS Clinic, Ibn Sina Hospital, P.O. Box 25427, Safat 13115, Kuwait.
Department of Medicine, Faculty of Medicine, Kuwait University, P.O. Box 24923, Safat 13110, Kuwait.
出版信息
Mult Scler Relat Disord. 2023 Nov;79:104941. doi: 10.1016/j.msard.2023.104941. Epub 2023 Aug 18.
BACKGROUND
Ocrelizumab is a humanized anti-CD20 antibody that has been approved for the treatment of patients with multiple sclerosis (MS). Real-world data in the Middle East is very limited.
OBJECTIVES
To describe the effectiveness and safety of ocrelizumab treatment in MS patients in a real clinical setting.
METHODS
This is an observational, registry-based study. MS patients who were treated with ocrelizumab and completed at least one-year follow-up post-treatment were included. Baseline clinical and radiological characteristics were collected before ocrelizumab initiation. The relapse rate, disability measures, magnetic resonance image (MRI) activity (new T2 lesions and/or GD+ enhancing T1 lesions), and adverse events (AE) at the last follow-up visits were assessed.
RESULTS
Data from 447 patients were analyzed, of which 260 (58.2%) were females. The mean age and mean disease duration were 37.39 ± 11.61 and 9.38 ± 7.57 years respectively. Most of the cohort was of a relapsing form (74.3%; n = 332), whereas active secondary and primary progressive forms represented 15.4% (n = 69) and 10.3% (n = 46) respectively. In the relapsing cohort, Ocrelizumab was prescribed in 162 (48.8%) patients due to highly active disease, and in 99 (29.8%) patients due to disease breakthrough while on prior therapies. In the last follow-up visits, most of the relapsing cohort was relapse-free (95.8% vs. 27.4%; p <0.001), had no evidence of MRI activity (3.6% vs. 67.5%; p <0.001) while EDSS score was stable (1.80+1.22 vs. 1.87+1.16; p < 0.104) when compared to baseline. NEDA-3 was achieved in 302 (91%) of RRMS patients. Confirmed disability progression was 27.5% and 23.9% in SPMS and PPMS respectively. Adverse events were observed in 139 (31.1%); infusion reactions and infections represented the most.
CONCLUSION
This study showed that ocrelizumab is an effective and safe treatment for MS patients in a real clinical setting similar to what was observed in clinical trials.
背景
奥瑞珠单抗是一种人源化抗 CD20 抗体，已被批准用于治疗多发性硬化症（MS）患者。在中东地区，真实世界的数据非常有限。
目的
描述奥瑞珠单抗在真实临床环境中治疗 MS 患者的有效性和安全性。
方法
这是一项观察性、基于登记的研究。纳入接受奥瑞珠单抗治疗且治疗后至少完成一年随访的 MS 患者。在开始奥瑞珠单抗治疗前收集基线临床和影像学特征。评估最后一次随访时的复发率、残疾程度、磁共振成像（MRI）活动（新的 T2 病变和/或 GD+增强 T1 病变）和不良事件（AE）。
结果
对 447 名患者的数据进行了分析，其中 260 名（58.2%）为女性。平均年龄和平均病程分别为 37.39±11.61 岁和 9.38±7.57 年。大多数患者为复发型（74.3%；n=332），而活跃的继发性和原发性进行性型分别占 15.4%（n=69）和 10.3%（n=46）。在复发型患者中，162 名（48.8%）患者因疾病高度活跃而开具奥瑞珠单抗处方，99 名（29.8%）患者因在前序治疗中疾病进展而开具奥瑞珠单抗处方。在最后一次随访时，与基线相比，大多数复发型患者无复发（95.8% vs. 27.4%；p<0.001），无 MRI 活动证据（3.6% vs. 67.5%；p<0.001），而 EDSS 评分保持稳定（1.80+1.22 vs. 1.87+1.16；p<0.104）。302 名（91%）RRMS 患者达到了 NEDA-3。SPMS 和 PPMS 中分别有 27.5%和 23.9%的患者确认残疾进展。139 名（31.1%）患者出现不良事件，最常见的是输注反应和感染。
结论
这项研究表明，奥瑞珠单抗在真实临床环境中是一种有效且安全的 MS 患者治疗方法，与临床试验中的观察结果相似。
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