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Drug profile

Ofatumumab subcutaneous injection for the treatment of relapsing forms of multiple sclerosis

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Pages 105-114 | Received 23 Jun 2021, Accepted 18 Jan 2022, Published online: 11 Feb 2022

References

  • MS Trust Types Of MS. 2020 Oct 1. [cited 2022 Feb 8]. Available fromhttps://www.Mstrust.Org.Uk/About-Ms/What-Ms/Types-Ms
  • MSIF & WHO. 2013. Atlas of Ms 2013: mapping multiple sclerosis around the world. [cited 2014 Sep 1]. Available from: https://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf
  • Wallin MT, Culpepper WJ, Nichols E, et al. Global, regional, and national burden of multiple sclerosis 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol. 2019b;18(3):269–285.
  • Montgomery SM, Kusel J, Nicholas R, et al. Costs and effectiveness of Fingolimod Versus Alemtuzumab in the treatment of highly active relapsing-remitting multiple sclerosis in the UK: re-treatment, discount, and disutility. J Med Econ. 2017;20(9):962–973.
  • Nylander A, Hafler DA. Multiple sclerosis. J Clin Invest. 2012;122(4):1180–1188.
  • Kurtzke J. Epidemiology of multiple sclerosis. Does this really point toward an etiology? Lectio doctoralis. Neurol Sci. 2000;21(6):383.
  • Brück W. The pathology of multiple sclerosis is the result of focal inflammatory demyelination with axonal damage. J Neurol. 2005;252(S5):V3–V9.
  • Ontaneda D, Fox R. Progressive multiple sclerosis. Curr Opin Neurol. 2015 Jun;28(3):237–243.
  • Huang W, Chen W, Zhang X. Multiple sclerosis: pathology, diagnosis and treatments. Exp Ther Med. 2017 Jun;13(6):3163–3166.
  • Lublin F, Reingold S, Cohen J, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014;83(3):278–286.
  • Thompson A, Banwell B, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the Mcdonald criteria. Lancet Neurol. 2018 Feb;17(2):162–173.
  • Tintore M, Arrambide G, Otero-Romero S, et al. The long-term outcomes Of CIS patients in the Barcelona inception cohort: looking back to recognize aggressive Ms. Mult Scler. 2020 Nov;26(13):1658–1669.
  • European Medicines Agency. Zeposia Epar. [cited 2020 Mar 26]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/zeposia
  • European Medicines Agency. Ponvory: pending Ec Decision. [cited 2021 Mar 25]. Available from https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-march-2021
  • Gajofatto A, Benedetti MD. Treatment strategies for multiple sclerosis: when to start, when to change, when to stop? World Journal Of Clinical Cases: Wjcc. 2015;3(7):545.
  • Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the guideline development, dissemination, and implementation subcommittee of The American Academy Of Neurology. Neurology. 2018;90(17):777–788.
  • Weinstock-Guttman B. An update on new and emerging therapies for relapsing-remitting multiple sclerosis. Am J Manag Care. 2013;19(17 Suppl):S343–54.
  • European Medicines Agency (Ema) 2017. Assessment report: ocrevus. [cited 2017 Nov 9]. Available from: https://Www.Ema.Europa.Eu/En/Documents/Assessment-Report/Ocrevus-Epar-Public-Assessment-Report_En.Pdf
  • Costello K, Kalb R, Antel J, et al. 2019. The use of disease-modifying therapies in multiple sclerosis: principles and current evidence: a consensus paper by the multiple sclerosis coalition. Society, S NM, editor. A Consensus Paper By The Multiple Sclerosis Coalition Ed.
  • Montalban X, Gold R, Thompson AJ, et al. Ectrims/Ean guideline on the pharmacological treatment of people with multiple sclerosis. Mult Scler. 2018;24(2):96–120.
  • Comi G, Dalla Costa G, Moiola L. Newly approved agents for relapsing remitting multiple sclerosis: how real-world evidence compares with randomized clinical trials? Expert Rev Neurother. 2021 Jan;21(1):21–34.
  • Sorensen P, Sellebjerg F, Hartung H, et al. The apparently milder course of multiple sclerosis: changes in the diagnostic criteria, therapy and natural history. Brain. 2020 Sep 1;143(9):2637–2652.
  • Lehmann-Horn K, Kronsbein HC, Weber MS. Targeting B cells in the treatment of multiple sclerosis: recent advances and remaining challenges. Ther Adv Neurol Disord. 2013;6(3):161–173.
  • Klein C, Lammens A, Schafer W, et al. Epitope interactions of monoclonal antibodies targeting CD20 and their relationship to functional properties. Mabs. 2013;5(1):22–33.
  • Harding FA, Stickler MM, Razo J, et al. The immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regions. MAbs. 2010 May-Jun;2(3):256–265.
  • Cataldi M, Vigliotti C, Mosca T, et al. Emerging role of the spleen in the pharmacokinetics of monoclonal antibodies, nanoparticles and exosomes. Int J Mol Sci. 2017;18(6):1249. Pmc5486072.
  • Viola M, Sequeira J, Seica R, et al. Subcutaneous delivery of monoclonal antibodies: how do we get there? J Control Release. 2018;286:301–314.
  • Richter WF, Jacobsen B. Subcutaneous absorption of biotherapeutics: knowns and unknowns. Drug Metab Dispos. 2014;42(11):1881–1889.
  • Baker D, Marta M, Pryce G, et al. Memory B cells are major targets for effective immunotherapy in relapsing multiple sclerosis. Ebiomedicine. 2017;16:41–50. Pmc5474520.
  • Bar-Or A, Grove RA, Austin DJ, et al. Subcutaneous Ofatumumab in patients with relapsing-remitting multiple sclerosis: the mirror study. Neurology. 2018;90(20):E1805–E1814 . Pmc5957306.
  • Center for drug evaluation and research: Ocrelizumab. cited 2016 Apr 28. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053orig1s000medr.pdf
  • Gelfand JM, Cree BAC, Hauser SL. Ocrelizumab and other Cd20(+) B-Cell- depleting therapies in multiple sclerosis. Neurotherapeutics. 2017;14(4):835–841. Pmc5722762.
  • Hauser SL, Bar-Or A, Comi G, et al., I. Opera, And O. I. C. Investigators. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3):221–234.
  • Ramwadhdoebe T, Van Baarsen L, Boumans M, et al. Effect of rituximab treatment on T And B cell subsets in lymph node biopsies of patients with rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1075–1085.
  • Gingele S, Jacobus TL, Konen FF, et al. Ocrelizumab depletes CD20+ T Cells in multiple sclerosis patients. Cells. 2019;8(1):12.
  • Ofatumumab Core Data Sheet V1.0. 2020 Jan 23. [cited 2022 Feb 8]. Available from: https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf
  • Naismith RT, Piccio L, Lyons JA, et al. Rituximab add-on therapy for breakthrough relapsing multiple sclerosis: a 52-week phase Ii trial. Neurology. 2010;74(23):1860–1867. 2882224.
  • Hauser SL, Waubant E, Arnold DL, et al. B-Cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med. 2008;358(7):676–688.
  • Greenwald M, Tesser J, Sewell K. Biosimilars have arrived: rituximab. Arthritis. 2018;2018:3762864. Published 2018 Mar 22.
  • Kappos L, Li D, Calabresi Pa OP, et al. Ocrelizumab in relapsing-remitting multiple sclerosis: a Phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779–1787.
  • Babiker H, Glode A, Cooke L, et al. Ublituximab for the treatment of Cd20 Positive B-Cell malignancies. Expert Opin Investig Drugs. 2018 Apr;27(4):407–412.
  • Fox E, Lovett-Racke AE, and Gormley M, et al. A phase 2 multicenter study of ublituximab, A novel glycoengineered anti-Cd20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis. Mult Scler. 2021;27(3):420–429.
  • Crofford LJ, Nyhoff LE, Sheehan JH, et al. The role of Bruton’s tyrosine kinase in autoimmunity and implications for therapy. Expert Rev Clin Immunol. 2016;12(7):763–773.
  • Traynor K. Ofatumumab Approved For Advanced Cll. Am J Health Syst Pharm. 2009 Dec 1;66(23):2062.
  • Østergaard M, Baslund B, Rigby W, et al. A human anti-Cd20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomized, double-blind, placebo-controlled, Phase I/Ii study. Arthritis Rheum. 2010 Aug;62(8):2227–2238.
  • Sorensen P, Lisby S, Grove R, et al. Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a Phase 2 study. Neurology. 2014 Feb 18;82(7):573–581.
  • Bar-Or A, Fox E, Goodyear A, et al. Onset of B-Cell depletion and suppression of mri activity with ofatumumab treatment in relapsing multiple sclerosis: the aplios study (3971). Neurology. 2020;94(15 Supplement):3971.
  • 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 Aug 6;383(6):546–557.
  • Wiendl H, Seze JD, Cross AH, et al. Serum immunoglobulin levels and infections in relapsing multiple sclerosis. Ecf 28th Annual Meeting, Baveno, Italy. Abstract 33, 2020
  • Kappos L, Wolinsky J, Giovannoni G, et al. Contribution of relapse-independent progression vs relapse-associated worsening to overall confirmed disability accumulation in typical relapsing multiple sclerosis in a pooled analysis of 2 randomized clinical trials. Jama Neurol. 2020;77(9):1132–1140.
  • Winkelmann A, Loebermann M, Reisinger E, et al. Disease-modifying therapies and infectious risks in multiple sclerosis. Nat Rev Neurol. 2016;12(4):217–233.
  • Luna G, Alping P, Burman J, et al. Infection risks among patients with multiple sclerosis treated with fingolimod, natalizumab, rituximab, and injectable therapies. Jama Neurol. 2020Feb1;77(2):184–191.
  • Hs N, Rosenbult C, Tremlett H. Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review. Expert Opin Drug Saf. 2020 Sep;19(9):1069–1094.
  • Raisch DW, Rafi JA, Chen C, et al. Detection of cases of progressive multifocal leukoencephalopathy associated with new biologicals and targeted cancer therapies from the FDA’s adverse event reporting system. Expert Opin Drug Saf. 2016;15(8):1003–1011.
  • Sormani M, De Rossi N, Schiavetti I, et al. Musc-19 Study Group. Disease-modifying therapies and coronavirus disease 2019 severity in multiple sclerosis. Ann Neurol. 2021 Apr;89(4):780–789.
  • FDA drug safety communication: boxed warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab). 2016 Feb 29. [cited 2022 Feb 8]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-boxed-warning-and-new-recommendations-decrease-risk-hepatitis-b
  • Alping P, Askling J, Burman J, et al. Cancer risk for fingolimod, natalizumab, and rituximab in multiple sclerosis patients. Ann Neurol. 2020 May;87(5):688–699.
  • O’connor P, Comi G, Freedman M, et al. Long-term safety and efficacy of teriflunomide: nine-year follow-up of the randomized temso study [published correction appears in neurology. 2016 Oct 4;87(14):1524]. Neurology. 2016;86(10):920–930.
  • Prosperini L, Haggiag S, and Tortorella C, et al. Age-related adverse events of disease-modifying treatments for multiple sclerosis: a meta-regression. Mult Scler. 2021;27(9):1391–1402.
  • Tran V, Miller P, Jarrar R, et al. Real world efficacy and safety profile of ocrelizumab therapy in patients with multiple sclerosis. Ectrims. 2019; Ep1557.
  • Eisenberg RA, Jawad AF, Boyer J, et al. Rituximab-treated patients have a poor response to influenza vaccination. J Clin Immunol. 2013 Feb;33(2):388–396.
  • Deepak P, Kim W, and Paley MA, et al. Effect of immunosuppression on the Immunogenicity of mRNA vaccines to SARS-CoV-2: a prospective cohort study. Ann Intern Med. 2021 Nov;174(11):1572–1585 .
  • Baker D, Roberts CAK, Pryce G, et al. COVID-19 vaccine-readiness for anti-CD20-depleting therapy in autoimmune diseases. Clin Exp Immunol. 2020 Nov;202(2):149–161.
  • European Medicines Agency. Kesimpta: pending Ec decision. cited 2021 Jan 29. Available from: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-25-29-january-2021
  • Comi G, Bar‐Or A, Lassmann H, et al. Expert panel of the 27th annual meeting of the European charcot foundation. Role of B Cells in multiple sclerosis and related disorders. Annals of Neurology. 2021 Jan;89(1):13–23.

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