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奥瑞珠单抗延长间隔给药治疗原发性进行性多发性硬化症:意大利经验。

Ocrelizumab Extended Interval Dosing in Primary Progressive Multiple Sclerosis: An Italian Experience.

机构信息

Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.

University of Modena and Reggio Emilia, Moderna, Emilia-Ronagna, Italy.

出版信息

Curr Neuropharmacol. 2024;22(2):339-345. doi: 10.2174/1570159X22666231002142709.

Abstract

BACKGROUND

The intervals between two courses of anti CD20 therapies in the COVID19 pandemic era provided the opportunity to individually delay therapy, known as extended interval dosing (EID).

METHODS

We collect real-world data on patients with primary progressive MS (PPMS) treated with Ocrelizumab (OCR) during the COVID'19 pandemic. The observation period in which the standard interval dosing (SID) or EID occurred (always a maintenance cycle, 600 mg) was from January 2020 to June 2021. All patients had two infusions during the observation period. Our first aim was to compare confirmed disability progression (CDP) between SID and EID patients.

RESULTS

From a total cohort of 410 patients treated with OCR, 96 patients fulfilled the inclusion criteria. All patients received two infusions during the index window, 71 received only SID infusions whilst 25 received at least one EID infusion throughout the entire follow-up. During the entire available follow-up (median 10 months, IQR 7-11), CDP was recorded in 5 patients (3/71, 4.2% SID and 2/25, 8% EID, V-Cramer = 0.141, p-value = 0.167). EID regimen did not influence the risk of CDP during the investigated follow up.

CONCLUSION

In our multicentre real-world cohort, the EID regimen in PPMS patients did not result in increased CDP during the available follow-up.

摘要

背景

在 COVID19 大流行期间,两次抗 CD20 治疗之间的间隔为个体延迟治疗提供了机会,即延长间隔给药(EID)。

方法

我们收集了 COVID19 大流行期间接受奥瑞珠单抗(OCR)治疗的原发性进展型多发性硬化症(PPMS)患者的真实世界数据。标准间隔给药(SID)或 EID 发生的观察期(始终为维持周期,600mg)为 2020 年 1 月至 2021 年 6 月。所有患者在观察期内均接受了两次输注。我们的第一个目的是比较 SID 和 EID 患者之间的确诊残疾进展(CDP)。

结果

在接受 OCR 治疗的 410 例患者中,有 96 例符合纳入标准。所有患者在指数窗口期间均接受了两次输注,71 例仅接受 SID 输注,而 25 例在整个随访期间至少接受了一次 EID 输注。在整个可获得的随访期间(中位数为 10 个月,IQR7-11),有 5 例患者(3/71,SID 为 4.2%,EID 为 2/25,8%,V-Cramer=0.141,p 值=0.167)记录到 CDP。在调查随访期间,EID 方案并未影响 CDP 的风险。

结论

在我们的多中心真实世界队列中,PPMS 患者的 EID 方案在可获得的随访期间并未导致 CDP 增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05db/10788893/31d8540a6527/CN-22-339_F1.jpg

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