Clinical recommendations for the use of ocrelizumab in patients with multiple sclerosis
https://doi.org/10.14412/2074-2711-2019-3-16-25
Abstract
About the Authors
A. N. BoykoRussian Federation
Department of Neurology, Neurosurgery, and Medical Genetics, 1, Ostrovityanov St., Moscow 117997;
Department of Neuroimmunology, 10, Ostrovityanov St., Moscow 117997
M. V. Davydovskaya
Russian Federation
Department of Neurology, Neurosurgery, and Medical Genetics,
1, Ostrovityanov St., Moscow 117997
N. V. Khachanova
Russian Federation
Department of Neurology, Neurosurgery, and Medical Genetics,
1, Ostrovityanov St., Moscow 117997
M. N. Zakharova
Russian Federation
80, Volokolamskoe Shosse, Moscow 125367
N. N. Spirin
Russian Federation
Department of Nervous System Diseases with Medical Genetics and Neurosurgery,
5, Revolyutionnaya St., Yaroslavl 150000
E. V. Popova
Russian Federation
10, Pistsovaya St., Moscow 127015
V. M. Alifirova
Russian Federation
Department of Neurology and Neurosurgery,
2, Moskovsky Road, Tomsk 634050
Ya. V. Vlasov
Russian Federation
Department of Neurology and Neurosurgery,
89, Chapaevskaya St., Samara 443099
S. A. Sivertseva
Russian Federation
12, Schiller St., Tyumen 625000
F. A. Khabirov
Russian Federation
13, Vatutin St., Kazan 420021
M. V. Shumilina
Russian Federation
11, Dynamo Pr., Saint Petersburg 197110
E. P. Evdoshenko
Russian Federation
11, Dynamo Pr., Saint Petersburg 197110
References
1. Spirin NN, Boiko AN, Stepanov IO, Shmidt TE, redaktory. Vedenie bol'nykh s rasseyannym sklerozom. Metodicheskie rekomendatsii [Management of patients with multiple sclerosis. Methodical recommendations]. Moscow: Zdorov'e cheloveka; 2015. 68 p.
2. Lehmann PV, Rottlaender A, Kuerten S. The autoimmune pathogenesis of multiple sclerosis. Pharmazie. 2015 Jan;70(1):5-11.
3. Von Bü dingen HC, Palanichamy A, Lehmann-Horn K, et al. Update on the autoimmune pathology of multiple sclerosis: B-cells as disease-drivers and therapeutic targets. Eur Neurol. 2015;73(3-4):238-46. doi: 10.1159/000377675. Epub 2015 Mar 25.
4. Claes N, Fraussen J, Stinissen P, et al. B Cells Are Multifunctional Players in Multiple Sclerosis Pathogenesis: Insights from Therapeutic Interventions. Front Immunol. 2015 Dec 21;6:642. doi: 10.3389/fimmu.2015. 00642. eCollection 2015.
5. Popova EV, Bryukhov VV, Boiko AN, et al. Primary-progressive multiple sclerosis as an atypical demyelinating process. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova 2016; 10(2):42-6. (In Russ.).
6. Hauser SL, Bar-Or A, Comi G; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.
7. Montalban X, Hauser SL, Kappos L; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.
8. Instruction for medical use of ocrelizumab (OCREVUS). Ministry of health of the Russian Federation http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=1e285065- d8dd-4438-b4f8-6358eced347c&t=
9. Kappos L, Hauser SL, Montalban X, et al. Safety of ocrelizumab in multiple sclerosis: updated analysis in patients with relapsing and primary progressive multiple sclerosis. 69th Annual Meeting. April 22–28. Boston; 2017. AAN Poster #407.
10. Davydovskaya MV, Khachanova NV, Evdoshenko EP, et al. Recommendations on drug selection algorithm and risk management plan for Natalizumab therapy in patients with remitting multiple sclerosis. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2016;10(2):79-97. (In Russ.).
11. Ho PR, Koendgen H, Campbell N, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: a retrospective analysis of data from four clinical studies. Lancet Neurol. 2017 Nov;16(11):925-933. doi: 10.1016/S1474-4422(17)30282-X. Epub 2017 Sep 29.
12. Alifirova VM, Bisaga GN, Boiko AN, et al. Clinical guidelines for the use of the drug alemtuzumab. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2017;2(2):115-26. (In Russ.).
13. Troshina EA, Sviridenko NYu, Vanushko VE, et al. Federal'nye klinicheskie rekomendatsii po diagnostike i lecheniyu tireotoksikoza s diffuznym zobom (diffuznyi toksicheskii zob, bolezn' Greivsa-Bazedova), uzlovym/mnogouzlovym zobom [Federal clinical guidelines for the diagnosis and treatment of thyrotoxicosis with diffuse goiter (diffuse toxic goiter, GravesBazedov disease), nodular / multi-nodular goiter]. Moscow; 2014.
14. Rotondi M, Molteni M, Leporati P, et al. Autoimmune Thyroid Diseases in Patients Treated with Alemtuzumab for Multiple Sclerosis: An Example of Selective Anti-TSHReceptor Immune Response. Front Endocrinol (Lausanne). 2017 Sep 28;8:254. doi: 10.3389/fendo.2017.00254. eCollection 2017.
15. Boiko AN, Boiko OV, Gusev EI. Selection of the optimal drug for pathogenetic treatment of multiple sclerosis: the current state of the problem. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2014;10(2):77-91. (In Russ.).
16. Wolinsky J, Giovannoni G, Hemmer B, et al. Ocrelizumab Efficacy in PPMS Patients in the Presence/Absence of T1 GadoliniumEnhancing Lesions at Baseline in a Phase III Placebo-Controlled Trial. The 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers. June 1-4. National Harbor; 2016. Oral Presentation DX06.
17. Naismith RT, Cascione M, Grimaldi LME, et al. Preliminary Results of the OPERA I and OPERA II Open-Label Extension Study. Academy of Managed Care Pharmacy (AMCP) 5th Nexus Conference. October 16-19. Dallas; 2017.
18. Alifirova VM, Bakhtiyarova KZ, Belova AN, et al. Clinical recommendations for the use of the drug teriflunomide. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2016;10(2):96-102. (In Russ.).
19. Khachanova NV, Davydovskaya MV, Evdoshenko EP. Updated risk stratification and risk minimization plan for natalizumab-associated progressive multifocal leukoencephalopathy. Russkii meditsinskii zhurnal. 2017;(13):3–7. (In Russ.).
20. Giovannoni G, Marta M, Davis A, et al. Switching patients at high risk of PML from natalizumab to another disease-modifying therapy. Pract Neurol. 2016 Oct;16(5):389-93. doi: 10.1136/practneurol-2015-001355. Epub 2016 Apr 25.
21. Willis M, Pearson O, Illes Z, et al. An observational study of alemtuzumab following fingolimod for multiple sclerosis. Neurol Neuroimmunol Neuroinflamm. 2017 Jan 10;4(2): e320. doi: 10.1212/NXI.0000000000000320. eCollection 2017 Mar.
22. Lugaresi A, di Ioia M, Travaglini D, et al. Risk-benefit considerations in the treatment of relapsing-remitting multiple sclerosis. Neuropsychiatr Dis Treat. 2013;9:893-914. doi: 10.2147/NDT.S45144. Epub 2013 Jun 24.
23. Clifford DB, Ances B, Costello C, et al. Rituximab-associated progressive multifocal leukoencephalopathy in rheumatoid arthritis. Arch Neurol. 2011 Sep;68(9):1156-64. doi: 10.1001/archneurol.2011.103. Epub 2011 May 9.
24. Zakharova NA, Semiglazov VF, Manikhas GM. Clinical guidelines of the Russian society of Oncomammology for breast cancer screening. Moscow; 2014. http://breastcancersociety.ru/rek/view/201
Review
For citations:
Boyko A.N., Davydovskaya M.V., Khachanova N.V., Zakharova M.N., Spirin N.N., Popova E.V., Alifirova V.M., Vlasov Y.V., Sivertseva S.A., Khabirov F.A., Shumilina M.V., Evdoshenko E.P. Clinical recommendations for the use of ocrelizumab in patients with multiple sclerosis. Neurology, Neuropsychiatry, Psychosomatics. 2019;11(3):16-25. (In Russ.) https://doi.org/10.14412/2074-2711-2019-3-16-25