PMID- 27272956 OWN - NLM STAT- MEDLINE DCOM- 20170411 LR - 20181113 IS - 1432-1459 (Electronic) IS - 0340-5354 (Print) IS - 0340-5354 (Linking) VI - 263 IP - 8 DP - 2016 Aug TI - Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse. PG - 1641-51 LID - 10.1007/s00415-016-8183-3 [doi] AB - 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. FAU - Jongen, Peter Joseph AU - Jongen PJ AD - 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. AD - MS4 Research Institute, Ubbergseweg 34, 6522 KJ, Nijmegen, The Netherlands. p.j.h.jongen@rug.nl. FAU - Stavrakaki, Ioanna AU - Stavrakaki I AD - to-BBB Technologies BV, J.H. Oortweg 19, 2333 CH, Leiden, The Netherlands. FAU - Voet, Bernard AU - Voet B AD - , Kollwitzstrasse 32, 10405, Berlin, Germany. FAU - Hoogervorst, Erwin AU - Hoogervorst E AD - Department of Neurology, St. Antonius Hospital, P.O. Box 2500, 3430 EM, Nieuwegein, The Netherlands. FAU - van Munster, Erik AU - van Munster E AD - Department of Neurology, Jeroen Bosch Hospital, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch, The Netherlands. FAU - Linssen, Wim H AU - Linssen WH AD - Department of Neurology, Onze Lieve Vrouwe Gasthuis, Jan Tooropstraat 164, 1061 AE, Amsterdam, The Netherlands. FAU - Sinnige, Ludovicus G AU - Sinnige LG AD - Multiple Sclerosis Center Leeuwarden, Medical Center Leeuwarden, Henri Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands. FAU - Verhagen, Wim I AU - Verhagen WI AD - Department of Neurology, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands. FAU - Visser, Leo H AU - Visser LH AD - Multiple Sclerosis Center Midden Brabant, ETZ, Location St. Elisabeth, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands. FAU - van der Kruijk, Ruud AU - van der Kruijk R AD - Department of Neurology, Slingeland Hospital, Kruisbergseweg 25, 7009 BL, Doetinchem, The Netherlands. FAU - Verheul, Freek AU - Verheul F AD - Department of Neurology, Groene Hart Hospital, Bleulandweg 10, 2803 HH, Gouda, The Netherlands. FAU - Boringa, Jan AU - Boringa J AD - Department of Neurology, Meander Medical Centre, Maatweg 3, 3813 TZ, Amersfoort, The Netherlands. FAU - Heerings, Marco AU - Heerings M AD - MH Advies and Organisatiebureau, IJselstraat 81, 9406 TR, Assen, The Netherlands. FAU - Gladdines, Werner AU - Gladdines W AD - to-BBB Technologies BV, J.H. Oortweg 19, 2333 CH, Leiden, The Netherlands. FAU - Lonnqvist, Fredrik AU - Lonnqvist F AD - to-BBB Technologies BV, J.H. Oortweg 19, 2333 CH, Leiden, The Netherlands. FAU - Gaillard, Pieter AU - Gaillard P AD - 2-BBB Medicines BV, J.H. Oortweg 19, 2333 CH, Leiden, The Netherlands. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20160607 PL - Germany TA - J Neurol JT - Journal of neurology JID - 0423161 RN - 0 (Anti-Inflammatory Agents) RN - X4W7ZR7023 (Methylprednisolone) SB - IM MH - Activities of Daily Living MH - Administration, Intravenous MH - Adult MH - Aged MH - Anti-Inflammatory Agents/administration & dosage/*adverse effects MH - *Disabled Persons/psychology MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Male MH - Methylprednisolone/administration & dosage/*adverse effects MH - Middle Aged MH - Multiple Sclerosis, Relapsing-Remitting/*drug therapy/*psychology MH - Online Systems/statistics & numerical data MH - Prospective Studies MH - *Self Report MH - Surveys and Questionnaires PMC - PMC4971042 OTO - NOTNLM OT - Adverse effect OT - High dose OT - Methylprednisolone OT - Multiple sclerosis OT - Patient-reported OT - Side effect EDAT- 2016/06/09 06:00 MHDA- 2017/04/12 06:00 PMCR- 2016/06/07 CRDT- 2016/06/09 06:00 PHST- 2016/04/09 00:00 [received] PHST- 2016/05/24 00:00 [accepted] PHST- 2016/05/24 00:00 [revised] PHST- 2016/06/09 06:00 [entrez] PHST- 2016/06/09 06:00 [pubmed] PHST- 2017/04/12 06:00 [medline] PHST- 2016/06/07 00:00 [pmc-release] AID - 10.1007/s00415-016-8183-3 [pii] AID - 8183 [pii] AID - 10.1007/s00415-016-8183-3 [doi] PST - ppublish SO - J Neurol. 2016 Aug;263(8):1641-51. doi: 10.1007/s00415-016-8183-3. Epub 2016 Jun 7.