Service de Neurologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, 1 Avenue Molière, 67000, Strasbourg, France.
Unité INSERM, 1119 Biopathologie de la Myéline, Neuroprotection et Stratégies Thérapeutiques, Strasbourg, France.
J Neurol. 2022 Sep;269(9):4846-4852. doi: 10.1007/s00415-022-11124-9. Epub 2022 Apr 17.
Anti-CD20 monoclonal antibodies are recently introduced treatments in progressive MS and real-world data are lacking.
The aim of this study is to describe a cohort of progressive MS patients treated with ocrelizumab or rituximab in a real-world setting.
This monocentric prospective cohort study at the University Hospital of Strasbourg included patients with primary progressive or secondary progressive MS that started treatment with anti-CD20 antibodies before June 2019. Every six months, patients were assessed using the following standardized clinical evaluations: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test (9-HPT) and Symbol Digit Modalities Test (SDMT). The primary analysis considered EDSS progression (of at least 1.0 if EDSS ≤ 5.5 and at least 0.5 if EDSS ≥ 6.0).
We included 108 patients, with a median age upon inclusion of 53 years [48.0-58.0]. 72% were classified as primary progressive forms. Median baseline EDSS was 6.0 [4.0-6.5]. EDSS was significantly correlated with T25FW, SDMT and 9-HPT. Following 2 years of treatment, 38.9% of patients presented EDSS progression compared to baseline.
Our large cohort confirms tolerance of these treatments in a real-world setting. Standardized clinical assessments could improve detection of deteriorating patients. Further studies are needed to establish predictive factors.
抗 CD20 单克隆抗体是最近引入的进展型多发性硬化症治疗方法，但缺乏真实世界的数据。
本研究旨在描述在真实环境中使用奥瑞珠单抗或利妥昔单抗治疗进展型多发性硬化症患者的队列。
这是斯特拉斯堡大学医院的一项单中心前瞻性队列研究，纳入了在 2019 年 6 月之前开始使用抗 CD20 抗体治疗的原发性进展型或继发性进展型多发性硬化症患者。每 6 个月，通过以下标准化临床评估对患者进行评估：扩展残疾状况量表（EDSS）、25 英尺步行测试（T25FW）、9 孔钉测试（9-HPT）和符号数字模态测试（SDMT）。主要分析考虑 EDSS 进展（EDSS≤5.5 时至少增加 1.0，EDSS≥6.0 时至少增加 0.5）。
我们纳入了 108 例患者，纳入时的中位年龄为 53 岁[48.0-58.0]。72%的患者被归类为原发性进展型。基线时的 EDSS 中位数为 6.0[4.0-6.5]。EDSS 与 T25FW、SDMT 和 9-HPT 显著相关。治疗 2 年后，与基线相比，38.9%的患者出现 EDSS 进展。
我们的大队列证实了这些治疗方法在真实环境中的耐受性。标准化的临床评估可以提高对病情恶化患者的检测。需要进一步的研究来确定预测因素。
