Preview

Neurology, Neuropsychiatry, Psychosomatics

Advanced search

Recommendations for switching patients with highly active multiple sclerosis from other disease modifying drugs for multiple sclerosis to cladribine tablets

https://doi.org/10.14412/2074-2711-2020-5-138-145

Full Text:

Abstract

The need for optimal treatment of the active forms of multiple sclerosis (MS), especially highly active MS (HAMS), poses a number of difficult problems for specialists, including not only the choice of a highly effective disease-modifying drug for MS (DMDMS), but also conditions for the timely and safe switching from other DMDMS. A group of expert neurologists from various clinics in Russia presents a consensus on the practical aspects of switching patients with HAMS from other DMDMS to cladribine tablets, which has been registered in Russia in March 2020. The paper discusses indications for changing therapy and gives indications, contraindications, and conditions for initiating cladribine therapy. It details the procedure and results of the expert consensus, on the basis of which the recommendations have been developed to switch to cladribine tablets from each of the DMDMS registered in Russia for the treatment of MS.

About the Authors

N. A. Totolyan
Acad. I.P. Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia
Russian Federation

Natalia A. Totolyan

6-8, Lev Tolstoy St., Saint Petersburg 197022



V. M. Alifirova
Siberian State Medical University, Ministry of Health of Russia
Russian Federation

2, Moskovsky High Road, Tomsk 634050



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

3, Lenin St., Ufa 450008,

132, Dostoevsky St., Ufa 450087



A. N. Boyko
N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia; Department of Neuroimmunology, Federal Center of Brain and Neurotechnologies, Federal Biomedical Agency of Russia
Russian Federation

1, Ostrovityanov St., Moscow 117997,

1, Ostrovityanov St., Build. 10, Moscow 117997



Ya. V. Vlasov
Samara State Medical University, Ministry of Health of Russia
Russian Federation

89, Chapaevskaya St., Samara 443099



Z. A. Goncharova
Rostov State Medical University, Ministry of Health of Russia
Russian Federation

29, Nakhichevansky Lane, Rostov-on-Don 344022



M. N. Zakharova
Research Center of Neurology
Russian Federation

80, Volokolamskoe Shosse, Moscow 125367



D. S. Kasatkin
Yaroslavl State Medical University, Ministry of Health of Russia
Russian Federation

5; Revolutsionnaya St., Yaroslavl 150000



S. V. Kotov
M.F. Vladimirsky Moscow Regional Research Clinical Institute
Russian Federation

61/2, Shchepkin St., Moscow 129110



A. I. Nilov
V.D. Seredavin Samara Regional Clinical Hospital
Russian Federation

159, Tashkentskaya St., Samara 443095



S. A. Sivertseva
AO «Neftyanik» Primary Healthcare Unit, Tyumen Regional Center for Multiple Sclerosis
Russian Federation

8, Yuri Semovskikh St., Build. 1, Tyumen 625000



A. A. Sokolova
Khanty-Mansi State Medical Academy; District Clinical Hospital

40, Mir St., Khanty-Mansiysk 628011,

40, Kalinin St., Khanty-Mansiysk 628011



N. N. Spirin
Yaroslavl State Medical University, Ministry of Health of Russia

5; Revolutsionnaya St., Yaroslavl 150000



F. A. Khabirov
Kazan State Medical Academy, Branch, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia; Republican Clinical Neurology Center

36; Butlerov St., Kazan 420012,

13, Vatutin St., Kazan 420021



D. Paradnika
OOO «Merk»OOO «Merk»

35, Valovaya St., Moscow 115054



References

1. Grand’Maison F, Yeung M, Morrow SA, et al. Sequencing of disease-modifying therapies for relapsing–remitting multiple sclerosis: a theoretical approach to optimizing treatment. Curr Med Res Opin. 2018 Aug;34(8):1419-30. doi: 10.1080/03007995.2018.1458023. Epub 2018 Apr 18.

2. 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.

3. Coyle PK. Switching therapies in multiple sclerosis. CNS Drugs. 2013 Apr;27(4):239-47. doi: 10.1007/s40263-013-0042-5

4. Ohlmeier C, Gothe H, Haas J, et al. Epidemiology, characteristics and treatment of patients with relapsing remitting multiple sclerosis and incidence of high disease activity: Real world evidence based on German claims data. PLoS One. 2020 May 1;15(5):e0231846. doi: 10.1371/journal.pone.0231846. eCollection 2020.

5. Freedman MS, Devonshire V, Duquette P, et al. Treatment Optimization in Multiple Sclerosis: Canadian MS Working Group Recommendations. Canad J Neurol Sci. 2020;47:437-55. doi: 10.1017/cjn.2020.66

6. Boyko AN, Boyko OV, Gusev YeI. The choice of the optimal drug for pathogenic treatment of multiple sclerosis: a current state of the problem (a review). Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. Spetsvypuski. 2014;114(10):77-91 (In Russ.).

7. Boiko AN, Gusev EI. Contemporary Algorithms for the Diagnosis and Treatment of Multiple Sclerosis Based on Individual Assessment of Patients’ Status. Neurosci Behav Physiol. 2018;48(7):870-82. doi: 10.1007/s11055-018-0642-0

8. Giovannoni G. Cladribine to treat relapsing forms of multiple sclerosis. Neurotherapeutics. 2017 Oct;14(4):874-87. doi: 10.1007/s13311-017-0573-4.

9. Giovannoni G, Comi G, Cook S, et al. 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.

10. Giovannoni G, Sorensen PS, 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 Scleros J. 2018;24(12):1594-604. doi: 10.1177/1352458517727603

11. Giovannoni G, Sorensen PS, 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 Scleros J. 2019;25(6):819- 27. doi: 10.1177/1352458518771875

12. Celius EG, Berg-Hansen P. Cladribine as treatment of multiple sclerosis, real world experience. Mult Scleros J. 2019;25:527-8.

13. Instructions for medical use of the drug Mavenclad (cladribine). Available from: https://medi.ru/instrukciya/mavenklad_16806/ (In Russ.).

14. Bakhtiyarova KZ, Boyko AN, Vlasov YaV, et al. Recommendations for the use of cladribine tablets for the pathogenetic treatment of patients with highly active multiple sclerosis. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2020;12(3):93-9. doi: 10.14412/2074-2711-2020-3-93-99 (In Russ.).

15. KKNMS Guidelines. 3rd ed. July 2018. Available from: https://www.kompetenznetz-multiplesklerose.de/wp-content/uploads/2018/11/KKNMS_Qualit%C3%A4tshandbuch-MSNMOSD_2018_webfrei.pdf (accessed 20 April 2020).

16. Cook S, Leist T, Comi G, et al. 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.

17. Sorensen PS, Heick A, Petersen T, et al. Danish experience with cladribine tablets in the treatment of relapsing multiple sclerosis: A nationwide study. Mult Scleros J. 2019;25:165.

18. Vermersch P, Martinelli V, Pfleger C, et al. Benefit-risk Assessment of Cladribine Using Multicriteria 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


For citation:


Totolyan N.A., Alifirova V.M., Bakhtiyarova K.Z., Boyko A.N., Vlasov Y.V., Goncharova Z.A., Zakharova M.N., Kasatkin D.S., Kotov S.V., Nilov A.I., Sivertseva S.A., Sokolova A.A., Spirin N.N., Khabirov F.A., Paradnika D. Recommendations for switching patients with highly active multiple sclerosis from other disease modifying drugs for multiple sclerosis to cladribine tablets. Neurology, Neuropsychiatry, Psychosomatics. 2020;12(5):138-145. (In Russ.) https://doi.org/10.14412/2074-2711-2020-5-138-145

Views: 54


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)