A randomized clinical trial of oral versus intravenous methylprednisolone for relapse of MS

C Ramo-Tello1, L Grau-López, M Tintoré

  • 1Hospital Germans Trias i Pujol, Spain.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|October 23, 2013
PubMed
Abstract

Insights

Oral methylprednisolone (oMP) is as effective as intravenous methylprednisolone (ivMP) for treating multiple sclerosis (MS) relapses. Both treatments showed similar improvements in disability scores and MRI lesions, with comparable safety profiles.

Area of Science:

  • Neurology
  • Immunology

Background:

  • Steroid therapy is a cornerstone for managing multiple sclerosis (MS) relapses, yet optimal administration routes, dosages, and frequencies remain subjects of investigation.
  • High-dose corticosteroids are frequently used, but the comparative efficacy and safety of oral versus intravenous routes require clarification.

Purpose of the Study:

  • To compare the clinical and radiologic efficacy, tolerability, and safety of high-dose intravenous methylprednisolone (ivMP) versus oral methylprednisolone (oMP) in patients experiencing MS relapses.

Main Methods:

  • A double-blind, noninferiority, multicenter trial randomized 49 patients with recent moderate to severe MS relapses to receive either ivMP or oMP.
  • Clinical efficacy was assessed using the Expanded Disability Status Scale (EDSS) at baseline and weeks 1, 4, and 12.
  • Radiologic efficacy was evaluated via brain MRI, focusing on T1 gadolinium-enhancing lesions and T2 lesions at weeks 1 and 4.

Main Results:

  • The study met its primary endpoint, demonstrating noninferiority of oMP compared to ivMP in EDSS improvement at four weeks.
  • No significant differences were observed between the groups regarding the number or volume of gadolinium-enhancing lesions or the count of new/enlarged T2 lesions.
  • Methylprednisolone, regardless of administration route, was well-tolerated, with no serious adverse events reported.

Conclusions:

  • Oral methylprednisolone (oMP) is a non-inferior alternative to intravenous methylprednisolone (ivMP) for treating multiple sclerosis relapses.
  • Both administration routes demonstrate comparable efficacy in improving clinical disability and reducing inflammatory MRI lesions.
  • The findings support the use of oral methylprednisolone as an equally safe and well-tolerated option for MS relapse management.

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