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Updated: Nov 11, 2025

Magnetic Resonance Imaging of Multiple Sclerosis at 7.0 Tesla
Published on: February 19, 2021
MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study
Stefania Federica De Mercanti1, Alessio Signori2, Cinzia Cordioli3
1Clinical and Biological Sciences Department, Neurology Unit, University of Torino, San Luigi Gonzaga Hospital, Orbassano, Torino, Italy.
Background:
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).
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:
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:
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.
Insights
Extending natalizumab dosing intervals for JCV-positive multiple sclerosis patients does not increase MRI activity. This suggests extended interval dosing (EID) may be a safe alternative to standard interval dosing (SID).
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Progressive Multifocal Leukoencephalopathy (PML) and rebound are risks for JCV-positive multiple sclerosis (MS) patients on natalizumab.
- Extending natalizumab administration intervals is proposed to mitigate these risks.
Purpose of the Study:
- To evaluate the efficacy of extended interval dosing (EID) versus standard interval dosing (SID) of natalizumab on MRI activity in JCV-positive MS patients.
Main Methods:
- An observational, multicentre, retrospective cohort study involving 316 JCV-positive MS patients.
- Patients were categorized into SID (<5 weeks) and EID (≥5 weeks) groups based on the median dose interval (MDI) after their 24th natalizumab infusion.
- MRI activity was assessed over 12 months post-infusion.
Main Results:
- The EID group (MDI 6.1 weeks) and SID group (MDI 4.5 weeks) showed similar risks of developing active MRI lesions at 6 and 12 months.
- Specifically, at 12 months, the risk was 8.50% for SID vs. 6.55% for EID (p=0.56).
- The EID regimen did not increase the occurrence of MRI activity during follow-up.
Conclusions:
- Extended interval dosing (EID) of natalizumab appears to maintain efficacy regarding MRI activity in JCV-positive MS patients.
- Further randomized studies are needed to confirm these findings and potentially adjust the standard natalizumab dosing schedule.
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