Some risk management issues in teriflunomide treatment of patients with remitting multiple sclerosis
https://doi.org/10.21518/2079-701X-2015-18-63-67
Abstract
New immunomodulatory drugs for the treatment of multiple sclerosis are emerging today in the pharmaceutical market. In Russia, new first line preparation - teriflunomide 14 mg in tablet form - was recently granted approval for the treatment of patients with remitting MS. The drug demonstrated good tolerability, efficacy and relative safety in long-term clinical trials. The article discusses an algorithm for the management of patients with RMS aimed at reducing the risk of adverse events associated with teriflunomide therapy.
About the Author
N. Y. Lasch
Neurosurgery and Medical Genetics of the Russian National Research Medical University named after N.I. Pirogov
Russian Federation
Russian Federation
References
1. Инструкция по медицинскому применению препарата Абаджио. 2014.
2. Бойко АН. Патогенетическое лечение рассеянного склероза и других аутоиммунных заболеваний нервной системы. В кн. «Аутоиммунные заболевания в неврологии». Клиническое руководство под. ред. И.А. Завалишина, М.А. Пирадова, А.Н. Бойко, С.С. Никитина, Н.Н. Спирина и А.В. Переседовой. РООИ «Здоровье человека», М., 2014, том 1, с. 285-344.
3. Limsakin T.,Menguy-Vacheron F.Pharmacokinetics of oral teriflunomide, a novel oral disease modifying agent under investigation for the treatment of MS. Presented at the Annual Meeting of the Americal Academy of Neurology (ANN) 2010.
4. O'Connor PW, Li D, Freedman MS et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006. 66(6): 894-90 O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011. 365: 1293-303. Confavreux C, O'Connor P, Comi G et al. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Mar. 13(3): 247-56. Freedman M, Wolinsky J, Comi G et al. Safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis treated with inter-feron beta. Presented at: 8th World Congress on Controversies in Neurology 2014. Berlin, Germany.
5. Kieiseier B, Benamor M, Truffinet P. Pregnancy outcomes for female patients and partners of male patients in the teriflunomide clinical development program. 2014 Joint ACTRIMS - ECTRIMS Meeting, September 10-13, 2014, Boston, MA, USA.
6. Kieiseier B, Struve O, Benamor M et al. Upated pregnancy outcomes from teriflunomide clinical development programme: retrospective analysis of the teriflunomide clinical trial database. Mult Scler. 2013. 19: 74, (P541).
7. Davenport L, Czich A, Turpault S. Teriflunomide: no effects on sperm DNA. Mult Scler. 2013. 19: 559 (P1187).
8. Limsakun T, Menguy-Vacheron F. Pharmaco-kinetics of oral teriflunomide, a novel oral dis-ease-modifiying agent under investigation for the treatment of MS. Presented at the Annual Meeting of the American Academy of Neurology (AAN). April 15, 2010. Toronto.
Review
For citations:
Lasch NY. Some risk management issues in teriflunomide treatment of patients with remitting multiple sclerosis. Meditsinskiy sovet = Medical Council. 2015;(18):63-67. (In Russ.) https://doi.org/10.21518/2079-701X-2015-18-63-67
Views:
389
Email this article 