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在从标准间隔到纳武利尤单抗延长间隔给药转换的复发缓解型多发性硬化症患者中,血清神经丝轻链没有增加。

No increase of serum neurofilament light in relapsing-remitting multiple sclerosis patients switching from standard to extended-interval dosing of natalizumab.

机构信息

Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden/Sahlgrenska University Hospital, Gothenburg, Sweden.

Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

出版信息

Mult Scler. 2022 Nov;28(13):2070-2080. doi: 10.1177/13524585221108080. Epub 2022 Jul 20.

Abstract

BACKGROUND

Accumulating evidence supports the efficacy of administering natalizumab (NZ) with extended-interval dosing (EID) in patients with relapsing-remitting multiple sclerosis (RRMS).

OBJECTIVES

We switched NZ dosing from 4-week to 6-week intervals in patients with RRMS, and investigated the effect on serum neurofilament light chain (sNfL) concentrations.

METHODS

We included two cohorts of patients with RRMS treated with NZ: one received the standard-interval dosing (4 weeks) at baseline, and were switched to 6-week intervals (EID4-6,  = 45). The other cohort received EID (5- or 6-week intervals) both at baseline and during follow-up (EID5/6,  = 25). Serum samples were collected in the EID4-6 cohort at every NZ infusion, for 12 months. The primary outcome was the change in sNfL concentrations after switching to EID.

RESULTS

The baseline mean sNfL concentration in the EID4-6 cohort was 10.5 ng/L (standard deviation (SD) = 6.1), and it remained unchanged at 12 months. Moreover, individual sNfL concentrations did not change significantly after extending the NZ dosing intervals. In addition, the EID4-6 and EID5/6 cohorts had similar baseline sNfL concentrations.

CONCLUSION

We concluded that extending the NZ dosing interval did not increase axonal damage, as determined with sNfL, in patients with RRMS.

摘要

背景

越来越多的证据支持在复发缓解型多发性硬化症(RRMS)患者中使用纳武利尤单抗(NZ)进行延长间隔给药(EID)。

目的

我们将 RRMS 患者的 NZ 给药间隔从 4 周延长至 6 周,并研究其对血清神经丝轻链(sNfL)浓度的影响。

方法

我们纳入了两批接受 NZ 治疗的 RRMS 患者:一批在基线时接受标准间隔给药(4 周),并转换为 6 周间隔(EID4-6,n=45)。另一批在基线和随访期间均接受 EID(5 或 6 周间隔)(EID5/6,n=25)。EID4-6 队列中的患者在每次 NZ 输注时采集血清样本,持续 12 个月。主要结局是转换为 EID 后 sNfL 浓度的变化。

结果

EID4-6 队列的基线平均 sNfL 浓度为 10.5ng/L(标准差(SD)=6.1),12 个月时保持不变。此外,延长 NZ 给药间隔后,个体 sNfL 浓度没有明显变化。此外,EID4-6 和 EID5/6 队列的基线 sNfL 浓度相似。

结论

我们得出结论,延长 NZ 给药间隔不会增加 RRMS 患者的轴突损伤,这可通过 sNfL 来确定。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/242d/9574231/a6056e7e207e/10.1177_13524585221108080-fig1.jpg

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