Patient-reported Adverse Effects of High-Dose Intravenous Methylprednisolone Treatment: A Prospective Web-Based Multi-Center Study in Multiple Sclerosis Patients With a Relapse

J Neurol. 2016 Aug;263(8):1641-51. doi: 10.1007/s00415-016-8183-3. Epub 2016 Jun 7.

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.

Keywords: Adverse effect; High dose; Methylprednisolone; Multiple sclerosis; Patient-reported; Side effect.

Publication types

  • Multicenter Study

MeSH terms

  • Activities of Daily Living
  • Administration, Intravenous
  • Adult
  • Aged
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects*
  • Disabled Persons* / psychology
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Methylprednisolone / administration & dosage
  • Methylprednisolone / adverse effects*
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Multiple Sclerosis, Relapsing-Remitting / psychology*
  • Online Systems / statistics & numerical data
  • Prospective Studies
  • Self Report*
  • Surveys and Questionnaires

Substances

  • Anti-Inflammatory Agents
  • Methylprednisolone