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.

Abstract

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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