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奥瑞珠单抗治疗多发性硬化症:不断变化的治疗环境中的真实世界经验。

Ocrelizumab use in multiple sclerosis: a real-world experience in a changing therapeutic scenario.

机构信息

Multiple Sclerosis Center, Department of Medical Sciences and Public Health, University of Cagliari, via Is Guadazzonis 2, 09126, Cagliari, Italy.

Department of Neurosciences, ARNAS Brotzu, Cagliari, Italy.

出版信息

Neurol Sci. 2024 Aug;45(8):3951-3959. doi: 10.1007/s10072-024-07449-0. Epub 2024 Mar 12.

Abstract

INTRODUCTION

CD20-depleting therapies are a real milestone in the treatment of multiple sclerosis (MS). This study examined the ocrelizumab (OCR) use in patients with primary progressive (PP) and relapsing remitting (RR) MS, also evaluating the predictors of treatment response.

METHODS

Patients with MS treated with OCR between 2017 and 2022 were included, and OCR use trends examined. The patients' characteristics were assessed at baseline and after 24 months of OCR to assess the NEDA-3 status.

RESULTS

This study included 421 patients: 33 (7.9%) with PP and 388 (92.1%) with RR MS. Among these, 67 (17.3%) were naïve, while switchers from first- and second-line disease-modifying therapies (DMTs) were 199 (51.3%) and 122 (31.4%), respectively. An increasing trend in OCR use was reported. For six patients treated with rituximab, OCR was chosen to improve tolerability; for 390 switcher patients, the choice was due to ineffectiveness; and for 25, as an exit strategy from natalizumab due to JC virus positivity. NEDA-3 status was calculated for subjects exposed to 24 months of OCR and was achieved by 163/192 (84.9%) RR patients and 9/16 (56%) PP patients, with younger age (p = 0.048) and annualized relapse rate in the year previous to OCR (p = 0.005) emerging as determinants. For the 25 patients who switched to OCR after natalizumab, no clinical or MRI activity after 12 months was reported.

CONCLUSION

OCR has been confirmed to be a highly efficacious option for patients with PP and RR MS, even proving to be a valid exit strategy for natalizumab.

摘要

简介

CD20 耗竭疗法是多发性硬化症(MS)治疗的一个真正的里程碑。本研究检查了奥瑞珠单抗(OCR)在原发性进展型(PP)和复发缓解型(RR)MS 患者中的使用情况,并评估了治疗反应的预测因素。

方法

纳入了 2017 年至 2022 年期间接受 OCR 治疗的 MS 患者,并检查了 OCR 使用趋势。在基线时和 OCR 治疗 24 个月后评估患者的特征,以评估 NEDA-3 状态。

结果

本研究纳入了 421 名患者:33 名(7.9%)为 PP,388 名(92.1%)为 RR MS。其中,67 名(17.3%)为初治患者,而从一线和二线疾病修饰疗法(DMTs)转换的患者分别为 199 名(51.3%)和 122 名(31.4%)。报告了 OCR 使用呈上升趋势。对于 6 名接受利妥昔单抗治疗的患者,选择 OCR 是为了提高耐受性;对于 390 名转换患者,选择 OCR 是因为疗效不佳;对于 25 名患者,由于 JC 病毒阳性,选择 OCR 是作为从那他珠单抗的退出策略。对暴露于 OCR 24 个月的患者计算了 NEDA-3 状态,并在 192 名 RR 患者中的 163 名(84.9%)和 16 名 PP 患者中的 9 名(56%)中达到,年轻年龄(p=0.048)和 OCR 前一年的年复发率(p=0.005)是决定因素。对于 25 名从那他珠单抗转换为 OCR 的患者,在 12 个月后没有报告临床或 MRI 活动。

结论

OCR 已被证实是 PP 和 RR MS 患者的一种非常有效的选择,甚至被证明是那他珠单抗的有效退出策略。

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