Similar biological effect of high-dose oral versus intravenous methylprednisolone in multiple sclerosis relapses

Mult Scler. 2015 Apr;21(5):646-50. doi: 10.1177/1352458514546786. Epub 2014 Aug 21.

Abstract

Our aim was to investigate differences in immune mechanisms in multiple sclerosis (MS) relapse, after high-dose oral methylprednisolone (oMP) or intravenous methylprednisolone (ivMP). We measured serum cytokines (IL-2, IL-4, IL-6, IL-10, IL-17, TNF-α and IFN-γ) in 39 of 49 MS patients with moderate-severe relapse, whom were treated with ivMP or oMP in a placebo-controlled, non-inferiority clinical trial. We assessed these cytokine levels at baseline and at 1 and 4 weeks post-treatment. The cytokine levels between oMP and ivMP were similar at any time. Proinflammatory cytokines (IL-6 and IFN-γ) were significantly decreased in both groups at week 1 (p = 0.05 / p = 0.03) and at week 4 (p = 0.04 / p = 0.05). This study provides further confirmatory evidence that oMP is not inferior to ivMP.

Trial registration: clinicaltrials.gov identifier: NCT00753792.

Keywords: Clinical trial; cytokines; dosage forms; methylprednisolone; multiple sclerosis; relapses.

Publication types

  • Clinical Trial, Phase IV
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravenous
  • Administration, Oral
  • Adolescent
  • Adult
  • Cytokines / metabolism
  • Disability Evaluation
  • Double-Blind Method
  • Female
  • Humans
  • Interferon-gamma / metabolism
  • Interleukin-6 / metabolism
  • Male
  • Methylprednisolone / administration & dosage*
  • Methylprednisolone / therapeutic use*
  • Middle Aged
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis / metabolism
  • Multiple Sclerosis / prevention & control
  • Recurrence
  • Young Adult

Substances

  • Cytokines
  • Interleukin-6
  • Interferon-gamma
  • Methylprednisolone

Associated data

  • ClinicalTrials.gov/NCT00753792