A phase II study of IV methylprednisolone in secondary-progressive multiple sclerosis

作者：Donald E. Goodkin, R. Philip Kinkel, Bianca Weinstock‐Guttman, S. VanderBrug Medendorp, Michelle Secic, D. Gogol, J. E. Perryman, Michele Messmer Uccelli, Laura K. Neilley · 发表于：Neurology · 年份：1998 · DOI：10.1212/wnl.51.1.239 · 被引用次数：110 · 研究领域：Multiple Sclerosis Research Studies、Peripheral Neuropathies and Disorders、Pathogenesis and Treatment of Hiccups

OBJECTIVE: To compare the tolerability and efficacy of two doses of i.v. methylprednisolone in patients with secondary-progressive MS. METHODS: I.v. methylprednisolone administered in high or low dose every other month for up to 2 years to 108 patients with secondary-progressive MS. RESULTS: No significant difference in efficacy with the primary outcome, a comparison of the proportions of patients in each treatment group who experienced sustained progression of disability. A relative treatment effect was detected with the high-dose regimen as measured by the preplanned secondary analysis, a comparison of time to onset of sustained progression of disability. Drug-related adverse events were observed more frequently in high-dose recipients but serious drug-related adverse events were uncommon, and cessation of study drug was only required in one patient. CONCLUSION: The results of the secondary analysis of this study suggest that a phase III trial of corticosteroids for secondary-progressive MS is warranted.