Recommendations for the use of cladribine tablets for the pathogenetic treatment of patients with highly active multiple sclerosis
Abstract
Currently, special attention is paid to timely treatment for active forms of multiple sclerosis (MS), especially for highly active MS (HAMS), in which there are ≥2 exacerbations and corresponding activity signs that are detected by magnetic resonance imaging (MRI) regardless of previous therapy with MS-modifying drugs (MSMDs) or there is ≥1 exacerbation and corresponding activity signs revealed by MRI during therapy with other MSMDs. A group of expert neurologists from various clinics in Russia, who actively participate in the clinical trials of cladribine tablets in MS, presents a consensus on the practical aspects of using the tablets of cladribine registered in Russia in March 2020 for the treatment of patients with HAMS. The paper mentions the groups of patients in whom the drug, an examination before starting a therapy cycle, routes of administration, and dose, and a monitoring scheme during and after treatment cycles are indicated. This drug acts on the principle of selective immunoreconstitution and may occupy an important place in the treatment of HAMS.
About the Authors
K. Z. Bakhtiyarova
G.G. Kuvatov Republican Clinical Hospital, Republican Center for Multiple Sclerosis; Bashkir State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
3, Lenin St., Ufa 450008; 132, Dostoevsky St., Ufa 450087.
Competing Interests: The conflict of interest has not affected the results of the investigation.
A. N. Boyko
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Department of Neuroimmunology, Federal Center for the Brain and Neurotechnologies, Federal Biomedical Agency
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
Aleksey Nikolaevich Boyko.
1, Ostrovityanov St., Moscow 117997;1, Ostrovityanov St., Build. 10, Moscow 117997.
Competing Interests: The conflict of interest has not affected the results of the investigation.
Ya. V. Vlasov
Samara State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
89, Chapaevskaya St., Samara 443099.
Competing Interests: The conflict of interest has not affected the results of the investigation.
Z. A. Goncharova
Rostov State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
29, Nakhichevansky Lane, Rostov-on-Don 344022.
Competing Interests: The conflict of interest has not affected the results of the investigation.
M. V. Davydovskaya
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Research and Practical Center for Clinical and Economic Analysis, Ministry of Health of the Moscow Region
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
1, Ostrovityanov St., Moscow 117997; 4A, Karbyshev St., Krasnogorsk 143403.
Competing Interests: The conflict of interest has not affected the results of the investigation.
M. N. Zakharova
Research Center of Neurology
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
80, Volokolamskoe Shosse, Moscow 125367.
Competing Interests: The conflict of interest has not affected the results of the investigation.
N. A. Malkova
Regional Center for Multiple Sclerosis, State Novosibirsk Regional Clinical Hospital; Novosibirsk State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
130, Nemirovich-Danchenko St., Novosibirsk 630087; 52, Krasnyi Prospect, Novosibirsk 630091.
Competing Interests: The conflict of interest has not affected the results of the investigation.
A. I. Nilov
V.D. Seredavin Samara Regional Clinical Hospital
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
159, Tashkentskaya St., Samara 443095.
Competing Interests: The conflict of interest has not affected the results of the investigation.
S. A. Sivertseva
AO «Neftyanik» Primary Healthcare Unit, Tyumen Regional Center for Multiple Sclerosis
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
8, Yuri Semovskikh St., Build. 1, Tyumen 625000.
Competing Interests: The conflict of interest has not affected the results of the investigation.
N. N. Spirin
Yaroslavl State Medical University, Ministry of Health of Russia
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
5, Revolutsionnaya St., Yaroslavl 150000.
Competing Interests: The conflict of interest has not affected the results of the investigation.
N. A. Totolyan
Acad. I.P. Pavlov First Saint Petersburg State Medical University
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
6—8, Lev Tolstoy St., Saint Petersburg 197022.
Competing Interests: The conflict of interest has not affected the results of the investigation.
F. A. Khabirov
Kazan State Medical Academy, Branch, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia; Republican Clinical Neurological Center
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
36, Butlerov St., Kazan 420012; 13, Vatutin St., Kazan 420021.
Competing Interests: The conflict of interest has not affected the results of the investigation.
M. V. Shumilina
City Clinical Hospital Thirty-One, City Center for Multiple Sclerosis
Russian Federation
Competing Interests: The conflict of interest has not affected the results of the investigation.
Russian Federation
3, Dynamo Prospect, Saint Petersburg 197110
Competing Interests: The conflict of interest has not affected the results of the investigation.
References
1. Diaz C, Zarco LA, Rivera DM. Highly active multiple sclerosis: An update. Mult Scler Relat Disord. 2019 May;30:215-24. doi: 10.1016/j.msard.2019.01.039. Epub 2019 Jan 24
2. Coyle PK, Oh J, Magyari M, et al. Management strategies for female patients of reproductive potential with multiple sclerosis: An evidence-based review. Mult Scler Relat Disord. 2019 Jul;32:54-63. doi: 10.1016/j.msard.2019.04.003. Epub 2019 Apr 5.
3. Registration certificate of the medicinal product Mavenclad (cladribin) LP-006137 from 10.03.2020.
4. Instructions for medical use of the drug Mavenclad (cladribine). https://medi.ru/instrukciya/mavenklad_16806/
5. Kawasaki H, Carrera CJ, Piro LD, et al. Relationship of deoxycytidine kinase and cytoplasmic 5'-nucleotidase to the chemotherapeutic efficacy of 2-chlorodeoxyadenosine. Blood. 1993 Feb 1;81(3):597-601.
6. Karussis D, Petrou P. Immune reconstitution therapy (IRT) in multiple sclerosis: the rationale. Immunol Res. 2018 Dec;66(6):642-48. doi: 10.1007/s12026-018-9032-5.
7. Giovannoni G. Cladribine to treat relapsing forms of multiple sclerosis. Neurotherapeutics. 2017 Oct;14(4):874-87. doi: 10.1007/s13311-017-0573-4.
8. Giovannoni G, Comi G, Cook S, et al; CLARITY Study Group. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5): 416-26. doi: 10.1056/NEJMoa0902533. Epub 2010 Jan 20.
9. Giovannoni G. Soelberg Sorensen P, Cook S, et al. Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study. Mult Scler. 2018 Oct;24(12):1594-1604. doi: 10.1177/1352458517727603. Epub 2017 Sep 5.
10. Giovannoni G, Soelberg Sorensen P, Cook S, et al. Efficacy of cladribine tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: a post hoc analysis of the CLARITY study. Mult Scler. 2019 May;25(6):819-27. doi: 10.1177/1352458518771875. Epub 2018 May 2.
11. Cook S, Leist Т, Comi G. Montalban X. Safety of cladribine tablets in the treatment of patients with multiple sclerosis: an integrated analysis. Mult Scler Relat Disord. 2019 Apr;29: 157-67. doi: 10.1016/j.msard.2018.11.021. Epub 2018 Nov 20.
12. Comi G, Cook S, Giovannoni G, et al. Effect of cladribine tablets on lymphocyte reduction and repopulation dynamics in patients with relapsing multiple sclerosis. Mult Scler Relat Disord. 2019 Apr;29:168-74. doi: 10.1016/j.msard.2019.01.038. Epub 2019 Jan 24.
13. Vermersch P, Martinelli V, Pfleger С, et al. Benefit-risk assessment of cladribine using multi-criteria decision analysis (MCDA) for patients with relapsing-remitting multiple sclerosis. Clin Ther. 2019 Feb;41(2):249-60.e18. doi: 10.1016/j.clinthera.2018.12.015.
14. Giovannoni G, Galazka A, Schick R, et al. Pregnancy outcomes during the clinical development programme of cladribine in multiple sclerosis (MS): an integrated analysis of safety for all exposed patients. 2020 May 23. doi: 10.1007/s40264-020-00948-x. Online ahead of print.
Review
Supporting agencies: This article has been supported by LLC Merck. The sponsor has participated in the development of the investigation project and supported the investigation program, as well as in the decision to submit the article for publication.
For citations:
Bakhtiyarova K.Z., Boyko A.N., Vlasov Y.V., Goncharova Z.A., Davydovskaya M.V., Zakharova M.N., Malkova N.A., Nilov A.I., Sivertseva S.A., Spirin N.N., Totolyan N.A., Khabirov F.A., Shumilina M.V. Recommendations for the use of cladribine tablets for the pathogenetic treatment of patients with highly active multiple sclerosis. Neurology, Neuropsychiatry, Psychosomatics. 2020;12(3):93-99. (In Russ.) https://doi.org/10.14412/2074-2711-2020-3-93-99
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