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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%).

journal_name

Neurology

journal_title

Neurology

authors

Martinelli V,Rocca MA,Annovazzi P,Pulizzi A,Rodegher M,Martinelli Boneschi F,Scotti R,Falini A,Sormani MP,Comi G,Filippi M

doi

10.1212/WNL.0b013e3181c3fd5b

subject

Has Abstract

pub_date

2009-12-01 00:00:00

pages

1842-8

issue

eissn

0028-3878

issn

1526-632X

pii

73/22/1842

journal_volume

pub_type

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A short-term randomized MRI study of high-dose oral vs intravenous methylprednisolone in MS.