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Zhuravleva M.V.

I.M. Sechenov First Moscow State Medical University (Sechenov University);
Scientific Centre of Medical Application Expertise of the Ministry of the Healthcare of the Russian Federation

Davydovskaya M.V.

Pirogov Russian National Research Medical University of the Ministry of Health of Russia;
Scientific and Practical Center for Clinical and Economic Analysis

Luchinina E.V.

Razumovsky Saratov State Medical University of the Ministry of Health of Russia

Shelekhova T.V.

Razumovsky Saratov State Medical University of the Ministry of Health of Russia

Kurguzova D.O.

Sechenov First Moscow State Medical University of the Ministry of Health of Russia;
Center for the Clinical Study of Medicinal Products of the Institute of Translational Medicine and Biotechnology of the Sechenov First Moscow State Medical University of the Ministry of Health of Russia

Serebrova S.Yu.

Scientific Center for Examination of Medical Devices;
Sechenov First Moscow State Medical University

Comparison of the clinical benefits of second-line drugs modifying the course of multiple sclerosis

Authors:

Zhuravleva M.V., Davydovskaya M.V., Luchinina E.V., Shelekhova T.V., Kurguzova D.O., Serebrova S.Yu.

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To cite this article:

Zhuravleva MV, Davydovskaya MV, Luchinina EV, Shelekhova TV, Kurguzova DO, Serebrova SYu. Comparison of the clinical benefits of second-line drugs modifying the course of multiple sclerosis. S.S. Korsakov Journal of Neurology and Psychiatry. 2020;120(8):148‑153. (In Russ.)
https://doi.org/10.17116/jnevro2020120081148

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References:

  1. Ulyanova OV, Kutashov VA. Comprehensive treatment of patients with multiple sclerosis in a multidisciplinary city hospital. Vestnik Kazakhskogo Natsionalnogo meditsinskogo universiteta. 2016;2:339-341. (In Russ.)
  2. Boyko A, Smirnova N, Petrov S, Gusev E. Epidemiology of MS in Russia, a historical review. Multiple Sclerosis and Demyelinating Disorders. 2016; 1:1:13.  https://doi.org/10.1186/s40893-016-0016-9
  3. Díaz C, Zarco L, Rivera DM. Highly active multiple sclerosis: An update. Multiple Sclerosis and Related Disorders. Published: Jan 24, 2019. https://doi.org/10.1016/j.msard.2019.01.039
  4. Kotov SV, Kudlay DA, Lizhdvoy VYu, Stashuk GA, Magomedova SB. The study of the effectiveness of the drug infibet in patients with multiple sclerosis based on the criteria of NEDA-3. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. Spetsvypuski. 2019;119:2:107-115. (In Russ.) https://doi.org/10.17116/jnevro201911922107
  5. Soelberg Sorensen P. Safety concerns and risk management of multiple sclerosis therapies. Acta Neurologica Scandinavica. 2016;136(3):168-186.  https://doi.org/10.1111/ane.12712
  6. Dörr J, Baum K. Alemtuzumab in the treatment of multiple sclerosis: patient selection and special considerations. Drug Design, Development and Therapy. 2016;10:3379-3386. https://doi.org/10.2147/dddt.s97956
  7. European Medicines Agency. Ocrevus summary of product characteristics. 2019.
  8. Havrdova E, Galetta S, Hutchinson M, Stefoski D, Bates D, Polman CH, O’Connor PW, Giovannoni G, Phillips JT, Lublin FD, Pace A, Kim R, Hyde R. Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study. The Lancet Neurology. 2009;8(3):254-260.  https://doi.org/10.1016/s1474-4422(09)70021-3
  9. Guarnera C, Bramanti P, Mazzon E. Comparison of efficacy and safety of oral agents for the treatment of relapsing — remitting multiple sclerosis. Drug Design, Development and Therapy. 2017;11:2193-2207. https://doi.org/10.2147/dddt.s137572
  10. Giovannoni G, Cook S, Rammohan K, Rieckmann P, Sørensen PS, Vermersch P, Hamlett A, Viglietta V, Greenberg S. Sustained disease-activity-free status in patients with relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysis. The Lancet Neurology. 2011;10(4):329-337.  https://doi.org/10.1016/s1474-4422(11)70023-0
  11. Dobson R, Giovannoni G. Multiple sclerosis — a review. European Journal of Neurology. 2018;26(1):27-40.  https://doi.org/10.1111/ene.13819
  12. Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung H-P, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DAS. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380:1829-1839. https://doi.org/10.1016/S0140-6736(12)61768-1
  13. Instructions for the medical use of the drug Lemtrada (alemtuzumab). Sept 13, 2019. (In Russ.)
  14. Instructions for the medical use of the drug Ocrevus (ocrelizumab). Aug 01, 2018. (In Russ.)
  15. Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung H-P, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376: 221-234.  https://doi.org/10.1056/NEJMoa1601277
  16. Rice GPA, Hartung H-P, Calabresi PA. Anti-alpha4 integrin therapy for multiple sclerosis: mechanisms and rationale. Neurology. 2005;64: 1336-1342. https://doi.org/10.1212/01.WNL.0000158329.30470.D0
  17. Instructions for medical use of the drug Tizabri (natalizumab). July 02, 2019. (In Russ.)
  18. Polman CH, O’Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006; 354:899-910.  https://doi.org/10.1056/NEJMoa044397
  19. Tysabri SPC. Biogen Idec Ltd, Berkshire, UK. European Medicines Agency. [ https://www.medicines.org.uk/emc/product/222
  20. Mehling M, Brinkmann V, Antel J, Bar-Or A, Goebels N, Vedrine C, Kristofic C, Kuhle J, Lindberg RLP, Kappos L. FTY720 therapy exerts differential effects on T cell subsets in multiple sclerosis. Neurology. 2008;71: 1261-1267. https://doi.org/10.1212/01.wnl.0000327609.57688.ea
  21. Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic effects in the immune and the central nervous system. Br J Pharmacol. 2009;158: 1173-1182. https://doi.org/10.1111/j.1476-5381.2009.00451.x
  22. Brinkmann V, Billich A, Baumruker T, Heining P, Schmouder R, Francis G, Aradhye S, Burtin P. Fingolimod (FTY720): discovery and development of an oral drug to treat multiple sclerosis. Nature Reviews Drug Discovery. 2010;9: 883-955.  https://doi.org/10.1038/nrd3324
  23. Pinschewer DD, Brinkmann V, Merkler D. Impact of sphingosine 1-phosphate modulation on immune outcomes. Neurology. 2011;76:15-19.  https://doi.org/10.1212/WNL.0b013e31820d9596
  24. Cohen JA, Barkhof F, Comi G, Hartung H-P, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362:402-415.  https://doi.org/10.1056/NEJMoa0907839
  25. Kappos L, Radue E-W, O’Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P. A placebocontrolled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362:387-401.  https://doi.org/10.1056/NEJMoa0909494
  26. Karussis D, Petrou P. Immune reconstitution therapy (IRT) in multiple sclerosis: the rationale. Immunologic Research. 2018;66(6):642-648.  https://doi.org/10.1007/s12026-018-9032-5
  27. Giovannoni G. Cladribine to treat relapsing forms of multiple sclerosis. Neurotherapeutics. 2017;14(4):874-887.  https://doi.org/10.1007/s13311-017-0573-4
  28. Instructions for the medical use of the drug Mavenclad (cladribine). (In Russ.)
  29. Leist TP, Vermersch P. The potential role for cladribine in the treatment of multiple sclerosis: clinical experience and development of an oral tablet formulation. Current Medical Research and Opinion. 2007;23(11):2667-2676. https://doi.org/10.1185/030079907x233142
  30. Giovannoni G, Sorensen PS, Cook S, Rammohan KW, Rieckmann P, Comi G, Dangond F, Hicking C, Vermersch P. Efficacy of cladribine tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: a post hoc analysis of the CLARITY study. Multiple Sclerosis Journal. 2019; 25(6):819-827.  https://doi.org/10.1177/1352458518771875
  31. Cook S, Leist T, Comi G, Montalban X, Giovannoni G, Nolting A, Hicking C, Galazka A, Sylvester E. Safety of cladribine tablets in the treatment of patients with multiple sclerosis: an integrated analysis. Multiple Sclerosis and Related Disorders. 2019;29:157-167.  https://doi.org/10.1016/j.msard.2018.11.021
  32. Electronic database of international clinical trials. Accessed Feb 20, 2020. (In Russ.) https://www.clinicaltrials.gov/ct2/show/NCT03961204?term=ClassicMS&draw=2&rank=1
  33. Lemtrada PI. Genzyme Corporation, MA, USA. Food and Drug Administration; 2018.
  34. FDA Safety Announcement. Drug safety and availability — FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug lemtrada (alemtuzumab) [ https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm
  35. Safety announcement of the Food and Drug Administration. FDA Safety Announcement 2018. Date of the application: May 24, 2019. (In Russ.) https://www.fda.gov/media/118875/download
  36. EMA Press Release 2019. Accessed May 24, 2019  https://www.ema.europa.eu/en/documents/press-release/use-multiple-sclerosis-medicine-lemtrada-restricted-while-ema-review-ongoing_en.pdf
  37. Rau D, Lang M, Harth A, Naumann M, Weber F, Tumani H, Bayas A. Listeria meningitis complicating alemtuzumab treatment in multiple sclerosis-report of two cases. Int J Mol Sci. 2015;16:14669-14676. https://doi.org/10.3390/ijms160714669
  38. Ocrevus SPC. Roche Products Limited, Hertfordshire, UK. European Medicines Agency. [ https://www.medicines.org.uk/emc/product/8898
  39. Gelfand JM, Cree BAC, Hauser SL. Ocrelizumab and other CD20+ B-cell-depleting therapies in multiple sclerosis. Neurotherapeutics. 2017;14(4):835-841.  https://doi.org/10.1007/s13311-017-0557-4
  40. Press-release NeuroSens Oct 30, 2019. Date of the application: Mar 04, 2020. https://neuro-sens.com/pml-reported-in-patient-newly-treated-with-ocrelizumab
  41. Singer BA. The role of natalizumab in the treatment of multiple sclerosis: benefits and risks. Ther Adv Neurol Disord. 2017;10:327-336.  https://doi.org/10.1177/1756285617716002
  42. Yukitake M. Drug‐induced progressive multifocal leukoencephalopathy in multiple sclerosis: A comprehensive review. Clinical and Experimental Neuroimmunology. 2018;9:37-47.  https://doi.org/10.1111/cen3.12440
  43. Bezabeh S, Flowers CM, Kortepeter C, Avigan M. Review article: clinically significant liver injury in patients treated with natalizumab (TYSABRITM). Aliment Pharmacol Ther. 2010. https://doi.org/10.1111/j.1365-2036.2010.04262.x
  44. Fonseca J. Fingolimod real world experience: efficacy and safety in clinical practice. Neurosci J. 2015. https://doi.org/10.1155/2015/389360
  45. Gilenya SPC. Novartis pharmaceuticals UK Ltd, Surrey, UK. European Medicines Agency. [ https://www.medicines.org.uk/emc/product/4545
  46. Instructions for medical use of the drug Guilenia (fingolimod). Oct 09, 2018. (In Russ.)
  47. Vargas WS, Perumal JS. Fingolimod and cardiac risk: latest findings and clinical implications. Ther Adv Drug Saf. 2013;4:119-124.  https://doi.org/10.1177/2042098613481023
  48. Berger JR, Cree BA, Greenberg B, Hemmer B, Ward BJ, Dong VM, Merschhemke M. Progressive multifocal leukoencephalopathy after fingolimod treatment. Neurology. 2018;90:1815-1821. https://doi.org/10.1212/WNL.0000000000005529
  49. Sempere AP, Berenguer-Ruiz L, Feliu-Rey E. Rebound of disease activity during pregnancy after withdrawal of fingolimod. Eur J Neurol. 2013;20:109-110.  https://doi.org/10.1111/ene.12195
  50. Giovannoni G, Soelberg Sorensen P, Cook S, Rammohan K, Rieckmann P, Comi G, Dangond F, Adeniji AK, Vermersch P. Safety and efficacy of cladribine tablets in patients with relapsing — remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study. Multiple Sclerosis Journal. 2018;24(12):1594-1604. https://doi.org/10.1177/1352458517727603

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