title: A short-term randomized MRI study of high-dose oral vs intravenous methylprednisolone in MS.
abstract: OBJECTIVE
  To compare the efficacy, tolerability, and safety of IV methylprednisolone (IV MP) vs oral methylprednisolone (oMP) at equivalent high doses in patients with multiple sclerosis (MS) experiencing a recent relapse.
  
  
  METHODS
  Patients with a clinical relapse within the previous 2 weeks and at least 1 gadolinium (Gd)-enhancing lesion on a screening brain MRI scan were included. Forty patients with MS were randomized to receive either 1 g/day for 5 days of oMP (20 patients) or 1 g/day for 5 days of IV MP (20 patients). Expanded Disability Status Scale (EDSS) and brain MRI (dual-echo and postcontrast T1-weighted scans) were assessed at baseline and at weeks 1 and 4. The study primary research question (endpoint) was to compare the efficacy of the 2 treatment routes in reducing the number of Gd-enhancing lesions after 1 week from treatment initiation. Secondary outcomes were safety, tolerability, and clinical efficacy profiles of the 2 routes of administration.
  
  
  RESULTS
  The 2 groups showed a reduction of Gd-enhancing lesions over time (p = 0.002 for oMP and p = 0.001 for IV MP) with a "non-inferiority effect" between the 2 routes of administration at week 1. Both groups showed an improvement of EDSS over time (p < 0.001) without between-group difference at week 4. Both treatments were well-tolerated and adverse events were minimal and occurred similarly in the 2 treatment arms.
  
  
  CONCLUSIONS
  Oral methylprednisolone (oMP) is as effective as IV methylprednisolone in reducing gadolinium-enhancing lesions in patients with MS soon after an acute relapse with similar clinical, safety, and tolerability profiles. This study provides class III evidence that 1 g oMP x 5 days is not inferior to 1 g IV MP x 5 days in reducing the number of gadolinium-enhancing lesions over a period of 1 week (mean difference in lesion reduction comparing IV MP to oMP is -20%, 95% confidence interval -48% to + 5%).
authors: Department of Neurology, Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, Scientific Institute and University Ospedale San Raffaele, Via Olgettina, 60, 20132 Milan, Italy. massimo.filippi@hsr.it
authors: V
authors: V
authors: Martinelli
authors: M A
authors: MA
authors: Rocca
authors: P
authors: P
authors: Annovazzi
authors: A
authors: A
authors: Pulizzi
authors: M
authors: M
authors: Rodegher
authors: F
authors: F
authors: Martinelli Boneschi
authors: R
authors: R
authors: Scotti
authors: A
authors: A
authors: Falini
authors: M P
authors: MP
authors: Sormani
authors: G
authors: G
authors: Comi
authors: M
authors: M
authors: Filippi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001921:Brain / Q000187:drug effects / Q000473:pathology*; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005682:Gadolinium; D006801:Humans; D007275:Injections, Intravenous / Q000379:methods; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000473:pathology; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D012372:ROC Curve; D018709:Statistics, Nonparametric; D013997:Time Factors; D055815:Young Adult
chemical_list: D018696:Neuroprotective Agents; D005682:Gadolinium; D008775:Methylprednisolone