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Ibudilast in relapsing-remitting multiple sclerosis: a neuroprotectant?

F Barkhof1, H E Hulst, J Drulovic

  • 1Department of Radiology, VU University Medical Center, MB, Amsterdam, The Netherlands. f.barkhof@vumc.nl

Neurology
|March 5, 2010
PubMed
Abstract

Insights

Ibudilast did not reduce new MS lesions or relapses but showed potential neuroprotective effects. This suggests a possible benefit in slowing disability progression in multiple sclerosis patients.

Area of Science:

  • Neuroscience
  • Immunology
  • Pharmacology

Background:

  • Ibudilast, a phosphodiesterase inhibitor, is investigated for its anti-inflammatory and neuroprotective properties in multiple sclerosis (MS).
  • This study assesses the safety and efficacy of two ibudilast dosages in patients with relapsing forms of MS.

Purpose of the Study:

  • To evaluate the safety and tolerability of ibudilast in relapsing MS.
  • To determine the effects of ibudilast on MRI-defined disease activity and clinical outcomes over 12 months.

Main Methods:

  • A multicenter, double-blind, placebo-controlled, phase 2 trial involving 297 patients with relapsing MS.
  • Patients received daily doses of 30 mg or 60 mg ibudilast or placebo for 12 months.
  • Primary endpoint: cumulative number of newly active lesions; secondary endpoints included relapse rate, EDSS, lesion volumes, and brain volume change.

Main Results:

  • No significant difference in newly active lesions or relapse rates between ibudilast and placebo groups.
  • A significant reduction in percent brain volume change (PBVC) was observed with 60 mg ibudilast compared to placebo (p=0.04).
  • Post hoc analyses indicated fewer active lesions evolving into persistent black holes with both ibudilast doses, and fewer patients experienced confirmed disability progression over 2 years.

Conclusions:

  • Ibudilast did not demonstrate efficacy in reducing new lesions or relapses in relapsing MS.
  • Preliminary MRI and clinical data suggest potential neuroprotective effects and a possible benefit in slowing disability progression.
  • Ibudilast was generally safe and well-tolerated in this patient population.

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