Neurol. praxi. 2019;20(5):362-367 | DOI: 10.36290/neu.2019.142

Safety monitoring of escalation treatment of multiple sclerosis

MUDr. Jiří Piťha
MS centrum při Neurologickém oddělení KZ, a. s. – Nemocnice Teplice, o. z., Teplice

Currently, ten drugs with a different mechanism of action are approved for the treatment of relapsing multiple sclerosis. Fingolimod, cladribine, natalizumab, alemtuzumab and ocrelizumab are very effective but are associated with some more serious side effects, some of which may be life-threatening. These drugs are second choice drugs and are usually chosen as escalation. For highly active forms of the disease, their potential can be exploited as induction therapy. The choice of optimal treatment is based on the knowledge of the mechanism of action, the benefit-risk balance and must be tailored to the individual patient. Patient preference, lifestyle, family planning, and co-morbidity should be taken into account. A number of examinations that minimize the possibility of undesirable effects should be performed before these drugs are used. Safety monitoring is performed during treatment. The risks associated with reactivating the disease or the consequences of previous treatment should be taken into account when discontinuing treatment.

Keywords: multiple sclerosis, safety, monitoring, disease modifying drugs

Published: November 1, 2019  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Piťha J. Safety monitoring of escalation treatment of multiple sclerosis. Neurol. praxi. 2019;20(5):362-367. doi: 10.36290/neu.2019.142.
Download citation

References

  1. Bielekova B, Becker BL. Monoclonal antibodies in MS: mechanisms of action. Neurology 2010; 74(Suppl. 1): S31-40. Go to original source... Go to PubMed...
  2. Clerico M, Artusi CA, Liberto AD, Rolla S, Bardina V, Barbero P, Mercanti SF, Durelli L. Natalizumab in Multiple Sclerosis: Long-Term Management. Int J Mol Sci. 2017; 18(5): 354-401. Go to original source... Go to PubMed...
  3. Cohen JA, Chun J. Mechanisms of fingolimod's efficacy and adverse effects in multiple sclerosis. Ann Neurol. 2011; 69: 759-777. Go to original source... Go to PubMed...
  4. Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 2012; 380: 1819-1828. Go to original source... Go to PubMed...
  5. Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 2012; 380: 1829-1839. Go to original source... Go to PubMed...
  6. Engelhardt B, Kappos L. Natalizumab: targeting alpha4-integrins in multiple sclerosis. Neurodegener Dis. 2008; 5(1): 16-22. Go to original source... Go to PubMed...
  7. Giovannoni G. Cladribine to Treat Relapsing Forms of Multiple Sclerosis. Neurotherapeutics 2017; 14(4): 874-887. Go to original source... Go to PubMed...
  8. Harding K, Williams O, Willis M, Hrastelj J, Rimmer A, Joseph F, Tomassini V, Wardle M, Pickersgill T, Robertson N, Tallantyre E. Clinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis. JAMA Neurol. 2019 Feb 18. doi: 10.1001/jamaneurol.2018.4905. Go to original source... Go to PubMed...
  9. Juanatey A, Blanco-Garcia L, Tellez N. Ocrelizumab: its efficacy and safety in multiple sclerosis. Rev Neurol. 2018; 66(12): 423-433. Go to original source...
  10. Merck Neurology HCP website, navštíveno 15. 4. 2019, dostupné z https://www.merckneurology.com/en/mavenclad/getting-started/monitoring.html.
  11. Schreiber K, Sörensen PS. Cladribine in the treatment of multiple sclerosis. Clin. Invest. 2011; 1(2): 317-326. Go to original source...
  12. S?rensen PS. Balancing the benefits and risks of disease-modifying therapy in patients with multiple sclerosis. J Neurol Sci. 2011; 311(Suppl 1): S29-34. Go to original source... Go to PubMed...
  13. SPC, Ocrevus, navštíveno 15. 4. 2019, dostupné z https://www.ema.europa.eu/en/documents/product-information/ocrevus-epar-product-information_cs.pdf
  14. Protokol studie WA21092F(RO4964913).
  15. Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing, navšívěno 18. 5. 2009, dostupné z https://www.ema.europa.eu/en/news/use-multiple-sclerosis-medicine-lemtrada-restricted-while-ema-review-ongoing.




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.