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Published on: December 9, 2015
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.
Background:
Steroids improve multiple sclerosis (MS) relapses but therapeutic window and dose, frequency and administration route remain uncertain.
Objective:
The objective of this paper is to compare the clinical and radiologic efficacy, tolerability and safety of intravenous methylprednisolone (ivMP) vs oral methylprednisolone (oMP), at equivalent high doses, for MS relapse.
Methods:
Forty-nine patients with moderate or severe relapse within the previous 15 days were randomized in a double-blind, noninferiority, multicenter trial to receive ivMP or oMP and their matching placebos. Expanded Disability Status Scale (EDSS) scores were determined at baseline and weeks 1, 4 and 12. Brain MRI were assessed at baseline and at weeks 1 and 4. Primary endpoint was a noninferiority assessment of EDSS improvement at four weeks (noninferiority margin of one point), with further key efficacy assessments of number and volume of T1 gadolinium-enhancing (Gd+), and new or enlarged T2 lesions at four weeks' post-treatment initiation. Secondary outcomes were safety and tolerability.
Results:
The study achieved the main outcome of noninferiority at four weeks for improved EDSS score. No differences were found between ivMP and oMP in the number of Gd+ lesions (0 (0-1) vs 0 (0-0.5), p = 0.630), volume of Gd+ lesions (0 (0-88.0) vs 0 (0-32.9) mm(3), p = 0.735), or new or enlarged T2 lesions (0 (0-194) vs 0 (0-123), p = 0.769). MP was well tolerated, and no serious adverse events were reported.
Conclusions:
This study provides confirmatory evidence that oMP is not inferior to ivMP in reducing EDSS, similar in MRI lesions at four weeks for MS relapses and is equally well tolerated and safe.
Trial Registration:
clinicaltrials.gov identifier: NCT00753792.
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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