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Ofatumumab – a new high-efficacy treatment for relapsing forms of multiple sclerosis


Authors: M. Vališ;  S. Halúsková
Authors place of work: Neurologická klinika LF UK a FN Hradec Králové
Published in the journal: Cesk Slov Neurol N 2021; 84(5): 436-440
Category: Přehledný referát
doi: https://doi.org/10.48095/cccsnn2021436

Summary

There has been tremendous progress in the treatment of MS over recent years. The concept of early treatment to achieve better outcomes in MS has clearly emerged, fully supported by long-term data. The efficacy of anti-CD20 monoclonal antibodies in the treatment of MS has been confirmed in clinical trials. Ofatumumab is a fully-humanized anti-CD20 monoclonal antibody approved for the treatment of adult patients with relapsing-remitting MS. Ofatumumab showed high efficacy and a favorable safety profile in phase III clinical trials, offering the first B-cell therapy that can be subcutaneously self-administered at home.

Keywords:

Multiple sclerosis – Monoclonal antibodies – treatment – ofatumumab


Zdroje

1. Cortese M, Riise T, Bjørnevik K et al. Preclinical disease activity in multiple sclerosis: a prospective study of cognitive performance prior to first symptom. Ann Neurol 2016; 80 (4): 616–624. doi: 10.1002/ana.24769.

2. Giovannoni G. The neurodegenerative prodrome in multiple sclerosis. Lancet Neurol 2017; 16 (6): 413–414. doi: 10.1016/S1474-4422 (17) 30127-8.

3. Giovannoni G, Butzkueven H, Dhib-Jalbut S et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord 2016; 9 (Suppl 1): S5–S48. doi: 10.1016/j.msard.2016.07.003.

4. Romeo MA, Martinelli V, Dalla Costa G et al. Assessing the role of innovative therapeutic paradigm on multiple sclerosis treatment response. Acta Neurol Scand 2018; 138 (5): 447–453. doi: 10.1111/ane.12999.

5. Kavaliunas A, Manouchehrinia A, Stawiarz L et al. Importance of early treatment initiation in the clinical course of multiple sclerosis. Mult Scler 2017; 23 (9): 1233–1240. doi: 10.1177/1352458516675039.

6. Capra R, Cordioli C, Rasia S et al. Assessing long-term prognosis improvement as a consequence of treatment pattern changes in MS. Mult Scler 2017; 23 (13): 1757–1761. doi: 10.1177/1352458516687402.

7. Gaetani L, Prosperini L, Mancini A et al. 2017 revisions of McDonald criteria shorten the time to dia­gnosis of multiple sclerosis in clinically isolated syndromes. J Neurol 2018; 265 (11): 2684–2687. doi: 10.1007/s00415-018-9048-8.

8. Cree BA, Mares J, Hartung HP. Current therapeutic landscape in multiple sclerosis: an evolving treatment paradigm. Curr Opin Neurol 2019; 32 (3): 365–377. doi: 10.1097/WCO.0000000000000700.

9. Ontaneda D, Tallantyre E, Kalincik T et al. Early highly effective versus escalation treatment approaches in relapsing multiple sclerosis. Lancet Neurol 2019; 18 (10): 973–980. doi: 10.1016/S1474-4422 (19) 30151-6.

10. Le Page E, Edan G. Induction or escalation therapy for patients with multiple sclerosis? Rev Neurol (Paris) 2018; 174 (6): 449–457. doi: 10.1016/j.neurol.2018.04.004.

11. Giovannoni G. Disease-modifying treatments for early and advanced multiple sclerosis: a new treatment paradigm. Curr Opin Neurol 2018; 31 (3): 233–243. doi: 10.1097/WCO.0000000000000561.

12. Harding K, Williams O, Willis M et al. Clinical outcomes of escalation vs early intensive disease-modifying therapy in patients with multiple sclerosis. JAMA Neurol 2019; 76 (5): 536–541. doi: 10.1001/jamaneurol.2018. 4905.

13. Brown JW, Coles A, Horakova D et al. Association of initial disease-modifying therapy with later conversion to secondary progressive multiple sclerosis. JAMA 2019; 321 (2): 175–187. doi: 10.1001/jama.2018.20588.

14. Gelfand JM, Cree BA, Hauser SL. Ocrelizumab and other CD20+ B-cell-depleting therapies in multiple sclerosis. Neurotherapeutics 2017; 14 (4): 835–841. doi: 10.1007/s13311-017-0557-4.

15. Sospedra M. B cells in multiple sclerosis. Curr Opin Neurol 2018; 31 (3): 256–262. doi: 10.1097/WCO.0000000 00000563.

16. Serafini B, Rosicarelli B, Magliozzi R et al. Detection of ectopic B-cell follicles with germinal centers in the meninges of patients with secondary progressive multiple sclerosis. Brain Pathol 2004; 14 (2): 164–174. doi: 10.1111/j.1750-3639.2004.tb00049.x.

17. Batista FD, Harwood NE. The who, how and where of antigen presentation to B cells. Nat Rev Immunol 2009; 9 (1): 15–27. doi: 10.1038/nri2454.

18. Li R, Rezk A, Miyazaki Y et al. Canadian B cells in MS Team. Proinflammatory GM-CSF-producing B cells in multiple sclerosis and B cell depletion therapy. Sci Transl Med 2015; 7 (310): 310ra166. doi: 10.1126/scitranslmed.aab4176.

19. Shen P, Fillatreau S. Antibody-independent functions of B cells: a focus on cytokines. Nat Rev Immunol 2015; 15 (7): 441–451. doi: 10.1038/nri3857.

20. Florou D, Katsara M, Feehan J et al. Anti-CD20 agents for multiple sclerosis: spotlight on ocrelizumab and ofatumumab. Brain Sci 2020; 10 (10): 758. doi: 10.3390/brainsci10100758.

21. Frisch ES, Pretzsch R, Weber MS. A milestone in multiple sclerosis therapy: monoclonal antibodies against CD20-Yet progress continues. Neurotherapeutics 2021 [ahead of print]. doi: 10.1007/s13311-021-01048-z.

22. Gasperi C, Stuve O, Hemmer B. B cell-directed therapies in multiple sclerosis. Neurodegener Dis Manag 2016; 6 (1): 37–47. doi: 10.2217/ nmt.15.67.

23. Milo R. Therapeutic strategies targeting B-cells in multiple sclerosis. Autoimmun Rev 2016; 15 (7): 714–718. doi: 10.1016/j.autrev.2016.03.006.

24. Delate T, Hansen ML, Gutierrez AC et al. Indications for rituximab use in an integrated health care delivery system. J Manag Care Spec Pharm 2020; 26 (7): 832–838. doi: 10.18553/jmcp.2020.26.7.832.

25. Hauser SL, Bar-Or A, Comi G et al. OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med 2017; 376 (3): 221–234. doi: 10.1056/NEJMoa1601 277.

26. Montalban X, Hauser SL, Kappos L et al.; ORATORIO Clinical Investigators. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med 2017; 376 (3): 209–220. doi: 10.1056/NEJMoa1606468.

27. Juanatey A, Blanco-Garcia L, Tellez N. Ocrelizumab: its efficacy and safety in multiple sclerosis. Rev Neurol 2018; 66 (12): 423–433.

28. Souhrn údajů o přípravku Kesimpta. [online]. Dostupné z URL: https: //www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_cs.pdf.

29. Teeling JL, Mackus WJ, Wiegman LJ et al. The bio­logical activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. J Immunol 2006; 177 (1): 362–371. doi: 10.4049/jimmunol.177.1.362.

30. Hauser SL, Bar-Or A, Cohen JA et al. ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in multiple sclerosis. N Engl J Med 2020; 383 (6): 546–557. doi: 10.1056/NEJMoa1917246.

31. Graham G, Yu H, David OJ et al. Rapid and sustained B-cell depletion with ofatumumab: population pharmacokinetic B-cell modeling in relapsing multiple sclerosis patients. ACTRIMS-ECTRIMS 2020, PO396.

32. Pandit L. No Evidence of Disease Activity (NEDA) in multiple sclerosis – shifting the goal posts. Ann Indian Acad Neurol 2019; 22 (3): 261–263. doi: 10.4103/aian.AIAN_159_19.

33. Lu G, Beadnall HN, Barton J et al. The evolution of „No Evidence of Disease Activity“ in multiple sclerosis. Mult Scler Relat Disord 2018; 20: 231–238. doi: 10.1016/j.msard.2017.12.016.

34. Hauser S, Bar-Or A, Cohen J et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Int J MS Care 2020; 22 (S2):  p85–p86.

35. Zapletalová O, Krejsek J. Roztroušená skleróza mozkomíšní, těhotenství, mateřství a kojení. Cesk Slov Neurol N 2019; 82/115 (2): 161–165. doi: 10.14735/amcsnn2019161.

36. Novartis. Pregnancy. [online]. Available from URL: https: //www.ofatumumabinfo.com/en/pregnancy.

37. Cheson BD. Ofatumumab, a novel anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. J Clin Oncol 2010; 28 (21): 3525–3530. doi: 10.1200/ JCO.2010.27.9836.

Štítky
Dětská neurologie Neurochirurgie Neurologie

Článek vyšel v časopise

Česká a slovenská neurologie a neurochirurgie

Číslo 5

2021 Číslo 5

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