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Published on: December 9, 2015
Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based
Peter Joseph Jongen1,2, Ioanna Stavrakaki3, Bernard Voet4
1Department of Community and Occupational Medicine, University Medical Center Groningen, University Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands. p.j.h.jongen@rug.nl.
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.
Insights
High-dose intravenous methylprednisolone (IVMP) frequently causes adverse effects (AEs) in multiple sclerosis (MS) patients, with many AEs being severe and impacting daily activities. Patients with severe MS or disability experience more frequent and severe AEs.
Area of Science:
- Neurology
- Pharmacology
- Clinical Research
Background:
- High-dose intravenous methylprednisolone (IVMP) is a common treatment for relapsing-remitting multiple sclerosis (MS) exacerbations.
- Understanding the adverse effects (AEs) of IVMP is crucial for patient management and treatment optimization.
Purpose of the Study:
- To evaluate the frequency, severity, and impact on activities of daily living (ADL) of AEs associated with high-dose IVMP in MS patients.
- To identify patient subgroups who may be at higher risk for experiencing severe AEs.
Main Methods:
- Prospective, multi-center observational study.
- Online self-report questionnaires administered at baseline, during, and after IVMP treatment.
- Inclusion of 85 relapsing-remitting MS patients experiencing a relapse.
Main Results:
- The majority of patients (96.6%) reported at least one AE, with a median of 4 AEs per patient.
- Most frequent AEs included taste changes (61%), facial flushing (61%), and stomach pain (53%).
- 34.3% of AEs were severe, and 37.9% impacted ADL. Patients with high disease impact or disability reported more frequent and severe AEs, particularly CNS-related ones.
Conclusions:
- High-dose IVMP treatment in MS patients invariably leads to AEs, with a significant proportion being severe and affecting daily life.
- Patients with higher disease impact or disability are more susceptible to experiencing a greater number and severity of AEs.
- Risk stratification and patient counseling regarding potential AEs are essential for effective IVMP therapy in MS.
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