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Efficacy and tolerability of natalizumab in relapsing-remitting multiple sclerosis patients: a post-marketing

F Sangalli1, L Moiola, S Bucello

  • 1Department of Neurology, INSPE, IRCCS H San Raffaele, via Olgettina 48, 20132, Milan, Italy.

Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
|June 15, 2010
PubMed

Insights

Natalizumab significantly reduced relapse rates and MRI activity in relapsing-remitting multiple sclerosis (MS) patients. This study confirms its efficacy in active MS, even in patients with higher disease activity.

Area of Science:

  • Neuroimmunology
  • Clinical Neurology
  • Pharmacology

Background:

  • Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
  • Natalizumab is an established therapy for relapsing-remitting MS (RRMS).
  • Evaluating natalizumab's real-world effectiveness in active RRMS is crucial.

Purpose of the Study:

  • To assess the efficacy and safety of natalizumab in patients with active relapsing-remitting multiple sclerosis (RRMS).
  • To analyze clinical and neuroradiological outcomes.
  • To monitor for neutralizing antibodies and treatment interruptions.

Main Methods:

  • Prospective observational study of 285 RRMS patients treated with natalizumab.
  • Data collection included clinical, neuroradiological, and safety parameters every 6 months.
  • Testing for natalizumab neutralizing antibodies (NABs) at 6 months.

Main Results:

  • Annualized relapse rate decreased from 2.13 to 0.26 after 1 year.
  • At 24 months, 78% of patients were relapse-free and 69% were MRI-free.
  • 63% of patients were considered "disease-free" based on combined clinical and MRI activity.
  • 18 patients developed NABs, and 34 treatment interruptions occurred.

Conclusions:

  • Natalizumab demonstrates significant efficacy in reducing relapse rates and MRI activity in active RRMS patients.
  • The drug's effectiveness was confirmed in a patient cohort with higher disease activity than seen in pivotal trials.
  • Safety monitoring, including NAB testing and observation for treatment interruptions, is essential.

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