MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study.

Humans Immunologic Factors / adverse effects Italy Leukoencephalopathy, Progressive Multifocal Magnetic Resonance Imaging Multiple Sclerosis / diagnostic imaging Multiple Sclerosis, Relapsing-Remitting Natalizumab / adverse effects Retrospective Studies

Efficacy Extended dose Magnetic resonance imaging Multiple sclerosis Natalizumab

Journal

Journal of the neurological sciences

ISSN: 1878-5883

Titre abrégé: J Neurol Sci

Pays: Netherlands

ID NLM: 0375403

Informations de publication

Date de publication:
15 May 2021

Historique:

received: 04 12 2020

revised: 22 02 2021

accepted: 02 03 2021

pubmed: 27 3 2021

medline: 15 5 2021

entrez: 26 3 2021

Statut: ppublish

Résumé

To minimize the risk of Progressive Multifocal Leukoencephalopathy and rebound in JCV-positive multiple sclerosis (MS) patients after 24 natalizumab doses, it has been proposed to extend the administrations interval. The objective is to evaluate the EID efficacy on MRI activity compared with the standard interval dosing (SID). Observational, multicentre, retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Three hundred and sixteen patients were enrolled. The median dose interval (MDI) following the 24th infusion was 5 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Patients were grouped into 2 categories according to the mean number of weeks between doses: <5 weeks, SID; ≥5 weeks, EID. One hundred and eighty-seven patients were in the SID group (MDI = 4.5 weeks) and 129 in the EID group (MDI 6.1 weeks). The risk to develop active lesions on MRI is similar in SID and EID groups during the 6 and 12 months after the 24th natalizumab infusion, respectively 4.27% (95% CI:0.84-7.70) vs 4.71% (95% CI:0.16-9.25%) [p = 0.89] and 8.50% (95% CI:4.05-12.95) vs 6.55% (95% CI:2.11-11.00%) [p = 0.56]. The EID regimen does not appear to increase the occurrence of MRI activity during follow-up. There is no evidence of the reduced efficacy of natalizumab in an EID setting regarding the MRI activity. This observation supports the need for a bigger randomized study to assess the need to change the standard of the natalizumab dosing schedule, to better manage JCV-positive patients.

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

Observational, multicentre, retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Three hundred and sixteen patients were enrolled. The median dose interval (MDI) following the 24th infusion was 5 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Patients were grouped into 2 categories according to the mean number of weeks between doses: <5 weeks, SID; ≥5 weeks, EID.

RESULTS RESULTS

One hundred and eighty-seven patients were in the SID group (MDI = 4.5 weeks) and 129 in the EID group (MDI 6.1 weeks). The risk to develop active lesions on MRI is similar in SID and EID groups during the 6 and 12 months after the 24th natalizumab infusion, respectively 4.27% (95% CI:0.84-7.70) vs 4.71% (95% CI:0.16-9.25%) [p = 0.89] and 8.50% (95% CI:4.05-12.95) vs 6.55% (95% CI:2.11-11.00%) [p = 0.56]. The EID regimen does not appear to increase the occurrence of MRI activity during follow-up.

CONCLUSION CONCLUSIONS

There is no evidence of the reduced efficacy of natalizumab in an EID setting regarding the MRI activity. This observation supports the need for a bigger randomized study to assess the need to change the standard of the natalizumab dosing schedule, to better manage JCV-positive patients.

Identifiants

DOI: 10.1016/j.jns.2021.117385 PMID: 33770708

pubmed: 33770708

pii: S0022-510X(21)00078-2

doi: 10.1016/j.jns.2021.117385

pii:

doi:

Substances chimiques

Immunologic Factors 0

Natalizumab 0

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

Pagination

117385