Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse.
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.
Department 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.|MS4 Research Institute, Ubbergseweg 34, 6522 KJ, Nijmegen, The Netherlands. p.j.h.jongen@rug.nl.
Peter Joseph
PJ
Jongen
to-BBB Technologies BV, J.H. Oortweg 19, 2333 CH, Leiden, The Netherlands.
Ioanna
I
Stavrakaki
, Kollwitzstrasse 32, 10405, Berlin, Germany.
Bernard
B
Voet
Department of Neurology, St. Antonius Hospital, P.O. Box 2500, 3430 EM, Nieuwegein, The Netherlands.
Erwin
E
Hoogervorst
Department of Neurology, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch, The Netherlands.
Erik
E
van Munster
Department of Neurology, Onze Lieve Vrouwe Gasthuis, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands.
Wim H
WH
Linssen
Multiple Sclerosis Center Leeuwarden, Medical Center Leeuwarden, Henri Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands.
Ludovicus G
LG
Sinnige
Department of Neurology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.
Wim I
WI
Verhagen
Multiple Sclerosis Center Midden Brabant, ETZ, Location St. Elisabeth, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands.
Leo H
LH
Visser
Department of Neurology, Slingeland Hospital, Kruisbergseweg 25, 7009 BL, Doetinchem, The Netherlands.
Ruud
R
van der Kruijk
Department of Neurology, Groene Hart Hospital, Bleulandweg 10, 2803 HH, Gouda, The Netherlands.
Freek
F
Verheul
Department of Neurology, Meander Medical Centre, Maatweg 3, 3813 TZ, Amersfoort, The Netherlands.
Jan
J
Boringa
MH Advies and Organisatiebureau, IJselstraat 81, 9406 TR, Assen, The Netherlands.
Marco
M
Heerings
to-BBB Technologies BV, J.H. Oortweg 19, 2333 CH, Leiden, The Netherlands.
Werner
W
Gladdines
to-BBB Technologies BV, J.H. Oortweg 19, 2333 CH, Leiden, The Netherlands.
Fredrik
F
Lönnqvist
2-BBB Medicines BV, J.H. Oortweg 19, 2333 CH, Leiden, The Netherlands.
Pieter
P
Gaillard
D000203:Activities of Daily Living; D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects*; D006233:Persons with Disabilities / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000523:psychology*; D009862:Online Systems / Q000706:statistics & numerical data; D011446:Prospective Studies; D057566:Self Report; D011795:Surveys and Questionnaires
D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone
Adverse effect; High dose; Methylprednisolone; Multiple sclerosis; Patient-reported; Side effect