Neurol. praxi. 2016;17(5):300-304 | DOI: 10.36290/neu.2016.062

Safety aspects of treating relapsing-remitting multiple sclerosis

MUDr. Radek Ampapa, MUDr. Stanislav Kopecký
Neurologické oddělení Nemocnice Jihlava

Multiple sclerosis a serious disease of the central nervous system in which an autoimmune inflammatory process is directed against the myelin sheaths of nerve fibres. In addition to inflammatory mechanisms, neurodegenerative processes are also involved. The treatment options for multiple sclerosis have been expanding considerably in the recent years and more novel drugs are expected to be available for use in the clinical practice within the next two years. This progress results not only in higher treatment efficacy, but also a wider spectrum of adverse effects. For this reason, careful monitoring of adverse effects, collaboration with other medical specialities, and benefit-risk ratio assessment of treatment in a particular patient are all necessary. The situation is even more complex in that not all drugs have comparable long-term data on safety. It is therefore essential to consider treatment in every patient strictly individually and have the patient participate in the discussion on choosing an optimal treatment strategy.

Keywords: multiple sclerosis, pharmacovigilance, disease-modifying drugs

Published: November 7, 2016  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Ampapa R, Kopecký S. Safety aspects of treating relapsing-remitting multiple sclerosis. Neurol. praxi. 2016;17(5):300-304. doi: 10.36290/neu.2016.062.
Download citation

References

  1. Assessment report - Tysabri. EMA - European Medicines Agency. 11 February 2016. EMA/PRAC/171485/2016. Pharmacovigilance Risk Assessment Committee (PRAC).
  2. Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevi RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Current Medical Research and Opinion. Volume 30, Issue 2, 2014: 251-262. Go to original source... Go to PubMed...
  3. Hauser SL, Comi GC, Hartung HP, Selmaj K, Traboulsee A, Bar-Or A, Arnold DL, Klingelschmitt G, Kakarieka A, Lublin F, Garren H, Kappos L. Efficacy and safety of ocrelizumab in relapsing multiple sclerosis - results of the interferon-beta-1a-controlled, double-blind, Phase III OPERA I and II studies. (Abstract release date: Sep 23, 2015) ECTRIMS Online Library. Hauser S. Oct 9, 2015; 116634.
  4. Havrdová E, Arnold DL, Cohen JA, Compston DAS, Fox EJ, Hartung HP, Selmaj KW, Margolin DH, Kasten L, Panzara MA, Coles AJ, on behalf of the CARE-MS I Investigators. Durable efficacy of alemtuzumab on clinical outcomes over 5 years in treatment-naive patients with active relapsing-remitting multiple sclerosis with most patients not receiving treatment for 4 years: CARE-MS 1 extension study. ECTRIMS Oct 9, 2015.
  5. Havrdová E, Blahová Dušánková H, Horáková D, Kleinová P, Kovářová I, Krejsek J, Libertínová J, Marečková H, Mareš J, Martásek P, Meluzínová E, Nytrová P, Piťha J, Preiningerová Lízrová J, Štětkářová I, Taláb R, Tichá V, Vachová M, Vaněčková M, Zámečník L. Roztroušená skleróza. MF Mladá fronta. 2013.
  6. Marriott JJ, Miyasa JM, Gronseth G, O'Connor PW. Evidence Report: The efficacy and safety of mitoxantrone (Novantrone) in the treatment of multiple sclerosis. Neurology. 2010; 74(18): 1463-1470. Go to original source... Go to PubMed...
  7. Milo R. The efficacy and safety of daclizumab and its potential role in the treatment of multiple sclerosis. Ther Adv Neurol Disord. 2014; 7(1): 7-21. Go to original source... Go to PubMed...
  8. Montalban X, Hemmer B, Rammohan K, Giovanni G, De Seze J, Bar-Or A. Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis - results of placebo-controlled, double-blind, Phase III ORATORIO study. ECTRIMS Oct 10, 2015: 116701.
  9. Schwab N, Schneider-Hohendorf T, Posevitz V, Breuer J, Göbel K, Windhagen S, Brochet B, Vermersch P, Lebrun-Frenay C, Posevitz-Fejfár A, Capra R, Imberti L, Straeten V, Haas J, Wildemann B, Havla J, Kümpfel T, Meinl I, Niessen K, Goelz S, Kleinschnitz C, Warnke C, Buck D, Gold R, Kieseier BC, Meuth SG, Foley J, Chan A, Brassat D, Wiendl H. L-selectin is a possible biomarker for individual PML risk in natalizumab-treated MS patients. Neurology. 2013; 81(10): 865-871. Go to original source... Go to PubMed...
  10. Tuohy O, Costelloe L, Hill-Cawthorne G, Bjornson I, Harding K, Robertson N, May K, Button T, Azzopardi L, Kousin-Ezewu O, Fahey MT, Jones J, Compston DA, Coles A. Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy. J Neurol Neurosurg Psychiatry. 2015; 86(2): 208-215. doi: 10.1136/jnnp-2014-307721. Epub 2014 May 21. Go to original source...




Neurology for Practice

Madam, Sir,
please be aware that the website on which you intend to enter, not the general public because it contains technical information about medicines, including advertisements relating to medicinal products. This information and communication professionals are solely under §2 of the Act n.40/1995 Coll. Is active persons authorized to prescribe or supply (hereinafter expert).
Take note that if you are not an expert, you run the risk of danger to their health or the health of other persons, if you the obtained information improperly understood or interpreted, and especially advertising which may be part of this site, or whether you used it for self-diagnosis or medical treatment, whether in relation to each other in person or in relation to others.

I declare:

  1. that I have met the above instruction
  2. I'm an expert within the meaning of the Act n.40/1995 Coll. the regulation of advertising, as amended, and I am aware of the risks that would be a person other than the expert input to these sites exhibited


No

Yes

If your statement is not true, please be aware
that brings the risk of danger to their health or the health of others.