Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse.

Peter Joseph Jongen,Wim H Linssen,Erwin Hoogervorst,Ruud Van Der Kruijk,Erik Van Munster,Marco Heerings,Fredrik Lönnqvist,Wim I Verhagen,Jan Boringa,Freek Verheul,Ludovicus G Sinnige,Bernard Voet,Werner Gladdines,Leo H Visser,Ioanna Stavrakaki,Pieter Gaillard

doi:10.1007/s00415-016-8183-3

Abstract

In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-report questionnaires stating IVMP’s most common AEs were completed at baseline, the 2nd day of treatment, and 1 day and 1 week after treatment. Eighty-five patients were included, 66 completed the baseline questionnaire, and 59 completed at least one post-baseline questionnaire. Patients reported on average 4 (median) AEs; two (3.4 %) reported no AE. Most frequent was change in taste (61 %), facial flushing (61 %), sick/stomach pain (53 %), sleep disturbance (44 %), appetite change (37 %), agitation (36 %), and behavioral changes (36 %). Of all AEs, 34.3 % were severe and 37.9 % impacted on ADL. A 3-day course resulted in 4 (median) AEs and a 5-day course in 7. All patients with high disease impact had two or more AEs, compared with 79 % of those with low impact (p < 0.01). Of patients with high disability, 45 % had severe AEs, compared with 16 % of those with low disability. Severe central nervous system (CNS)-related AEs occurred two times more frequently in patients with high disease impact, and two-and-a-half times more frequently in patients with high disability. Therefore, in virtually all patients, high-dose IVMP leads to AEs, with about one of three AEs being severe with impact on ADL. Patients with high disease impact or high disability may experience more (severe) AEs, due to a higher occurrence of severe CNS-related AEs.Electronic supplementary materialThe online version of this article (doi:10.1007/s00415-016-8183-3) contains supplementary material.

Highlights

Multiple sclerosis (MS) is a chronic disease of the central nervous system (CNS), in which immune-mediated inflammation and degeneration lead to loss of myelin and axons
In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse
The primary objective was to investigate in patients with relapsing-remitting MS (RRMS) and clinically isolated syndrome (CIS) who were treated with IVMP for a relapse, the frequency, severity, bothering, and impact on activities of daily living (ADL) of AEs; the secondary objective was to investigate the relationship between AEs and the duration of the treatment course (3-day vs. 5-day course), IVMP treatment in the previous two years, and MS-related disease impact and disability

Summary

Introduction

Multiple sclerosis (MS) is a chronic disease of the central nervous system (CNS), in which immune-mediated inflammation and degeneration lead to loss of myelin and axons. Most patients fully recover after a relapse, but this can take weeks or months [2]. Treatment with high-dose methylprednisolone shortens the relapse duration and increases the chances of recovery [3]. Methylprednisolone, like other corticosteroids, is associated with a number of adverse effects (AEs), affecting the skin, skeleton, muscles, eyes, CNS, electrolytes, metabolism, and the endocrine, cardiovascular, immune, and gastrointestinal systems, often in a dose-dependent manner [4]. Most serious AEs are related to the long-term oral use, short-term steroid-induced symptoms are frequent, especially with high-dose treatment needed to treat relapses [6]

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