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Head-to-Head Comparison of IV and Oral Methylprednisolone for MS Relapses

June 11, 2014

Head-to-Head Comparison of IV and Oral Methylprednisolone for MS Relapses

  1. Robert T. Naismith, MD

In equivalent doses, both oral and intravenous formulations were associated with improvement at weeks 1 and 4.

  1. Robert T. Naismith, MD

Patients with a multiple sclerosis (MS) relapse affecting function and quality of life are offered intravenous (IV) methylprednisolone (MP), 1000 mg per day for 3 to 5 days, to hasten recovery. For cost and convenience reasons, some physicians prescribe oral (O) MP in an equivalent dose (i.e., prednisone 20 mg tablets, 20 tablets per day for 3 to 5 days). Data on relative efficacies have not been available.

In this multicenter, double-blind, placebo-controlled, randomized trial, researchers recruited 49 patients with moderate MS relapses. Treatment was IVMP at 1000 mg per day for 3 days or OMP at 1250 mg per day for 3 days. The study was 80% powered for noninferiority between the two preparations based on a 1-point difference on the Expanded Disability Status Scale (EDSS).

Among the 44 patients who finished the study, 4-week outcomes included a change from baseline EDSS of −1.13 for IVMP vs. −1.06 for OMP; the 0.07-point difference was nonsignificant. The proportions of patients with a 1-point or greater improvement on EDSS did not differ between the treatment groups: 46% on OMP vs. 39% on IVMP at week 1; 68% vs. 65% at week 4; and 73% vs. 70% at week 12. Improvement in gadolinium-enhancing lesions was, likewise, similar: 22% with OMP vs. 13% with IVMP at week 1, and 26% vs. 22%, respectively, at week 4.

Comment

This small study provides class I evidence that oral and IV formulations of glucocorticoids, when used in equivalent doses, provide comparable efficacies in improving disability for those with moderately severe MS relapses. For patients with medical comorbidities and those with severe relapses that affect activities of daily living, ambulation, and generalized function, one might prefer hospitalization with IVMP for monitoring and rehabilitation evaluation.

  • Disclosures for Robert T. Naismith, MD at time of publication Consultant / Advisory board Acorda Therapeutics; Bayer Healthcare; Biogen Idec; EMD Serono; Genzyme Corp/Sanofi; Genetech; Questcor Grant / Research support National Multiple Sclerosis Society; Acorda Therapeutics Leadership positions in professional societies American Neurological Association (Scientific Program Advisory Committee)

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