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Natalizumab in the pediatric MS population: results of the Italian registry

Angelo Ghezzi1, Lucia Moiola2, Carlo Pozzilli3

  • 1Multiple Sclerosis Study Center, Hospital of Gallarate, Via Pastori 4, 21013, Gallarate, Italy. angelo.ghezzi@aogallarate.it.

BMC Neurology
|September 27, 2015
PubMed

Insights

Natalizumab (NA) significantly reduced relapses and disability in pediatric multiple sclerosis (MS) patients. This study shows NA is safe and effective for aggressive pediatric MS cases.

Area of Science:

  • Neurology
  • Immunology

Background:

  • Natalizumab (NA) is a potential treatment for pediatric multiple sclerosis (MS) with active disease unresponsive to Interferon-beta or Glatiramer Acetate.
  • Limited data exist on large cohorts and long-term outcomes of NA in pediatric MS.

Purpose of the Study:

  • To evaluate the safety and efficacy of Natalizumab (NA) in a large cohort of pediatric multiple sclerosis (MS) patients.
  • To assess long-term outcomes, including relapse rates, disability progression, and MRI activity.

Main Methods:

  • A registry was established in Italy in 2007 to collect data on MS patients under 18 treated with NA.
  • Data collected included age of onset, age at NA initiation, treatment duration, relapse rates, Expanded Disability Status Scale (EDSS) scores, and MRI findings.

Main Results:

  • 101 pediatric MS patients were included, with a mean age of onset of 12.9 years.
  • NA treatment led to a significant reduction in annualized relapse rate (from 2.3 to 0.1, p < 0.001) and EDSS scores (from 2.6 to 1.8, p < 0.001).
  • 58% of patients achieved no evidence of disease activity (NEDA) by the last observation, with no significant adverse events reported.

Conclusions:

  • Natalizumab (NA) is safe, well-tolerated, and highly effective in the majority of pediatric MS patients.
  • The findings support the use of NA for pediatric MS patients experiencing an aggressive disease course.
  • NA treatment resulted in substantial improvements in clinical and MRI outcomes compared to the pre-treatment period.
Abstract

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