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Related Experiment Videos

Natalizumab in multiple sclerosis: proceed with caution?

Sheila A Doggrell1

  • 1School of Science, Charles Darwin University, PO Box 41246, Casuarina, Northern Territory, 0811 Australia. sheila.doggrell@cdu.edu.au

Expert Opinion on Pharmacotherapy
|July 29, 2006
PubMed
Summary

Natalalizumab reduces relapses in multiple sclerosis (MS) but carries a risk of progressive multifocal leukoencephalopathy (PML). Long-term safety monitoring in clinical trials is recommended before widespread use.

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Area of Science:

  • Neurology
  • Immunology
  • Clinical Pharmacology

Background:

  • Multiple sclerosis (MS) is a CNS autoimmune disease.
  • Natalalizumab demonstrated efficacy in reducing relapses in relapsing MS during Phase II trials.
  • Concerns regarding progressive multifocal leukoencephalopathy (PML) led to its withdrawal after FDA approval.

Purpose of the Study:

  • To report on completed clinical trials of natalalizumab for relapsing MS.
  • To assess the safety and efficacy of natalalizumab in managing MS.
  • To evaluate the incidence of PML associated with natalalizumab use.

Main Methods:

  • Analysis of completed Phase III clinical trial data for natalalizumab in relapsing MS.
  • Evaluation of relapse rates and lesion development in patients treated with natalalizumab.

Related Experiment Videos

  • Assessment of PML incidence in patients receiving natalalizumab, including long-term use.

    • Main Results:

    • Natalalizumab monotherapy reduced relapse rates and lesions without causing PML in a trial of 1171 subjects.
    • While reducing relapses and lesions in patients also taking IFN-beta, two cases of PML occurred.
    • An assessment of approximately 3000 patients using natalalizumab for 1-2 years showed a PML incidence of 1/1000.

    Conclusions:

    • Natalalizumab is effective in reducing relapses and lesions in relapsing MS.
    • The risk of PML associated with natalalizumab necessitates careful consideration for long-term therapy.
    • Further long-term safety monitoring in a clinical trial setting is crucial before widespread patient use.