305
Views
24
Downloads
0
Crossref
N/A
WoS
N/A
Scopus
N/A
CSCD
Ofatumumab is the first monoclonal antibody developed specifically for treating relapsed multiple sclerosis (RMS). This disease (Multiple Sclerosis) includes relapsing–remitting multiple sclerosis (RRMS), a chronic autoimmune illness that affects the central nervous system (CNS), including the brain and spinal cord. The purpose of this study is to determine whether Ofatumumab is efficacious and safe in the treatment of relapsing–remitting multiple sclerosis.
An analysis of studies comparing Ofatumumab with placebo in people with relapsing‐remitting multiple sclerosis was done in accordance with PRISMA guidelines. We looked up information in MEDLINE, SciSearch, BIOSIS Previews, Derwent Drug File, Embase, and International Pharmaceutical Abstracts. In patients with relapsing–remitting multiple sclerosis, randomized double‐blind and non‐randomized trials contrasting Ofatumumab with placebo were found by two independent investigators. Utilizing Review Manager 5.4.1, data were examined. The main results were total gadolinium‐enhancing (Gd+) T1 lesions, annualized relapse rate, and new or expanding total T2 lesions. Secondary outcomes concentrated on general adverse events and adverse events related to infections.
Three studies were included involving 334 patients, and the meta‐analysis indicated that Ofatumumab showed good efficacy and safety in patients with relapsing forms of multiple sclerosis. The annual rate of relapse was significantly reduced by Ofatumumab (OR 0.51; 95% CI 0.27, 0.98; P = 0.04). Ofatumumab reduced the number of gadolinium‐enhancing (Gd+) T1 lesions per scan (Mean difference −0.59; 95% CI −0.63, −0.55; P < 0.05). Ofatumumab treatment decreased new or enlarging total T2 lesions significantly (Mean difference −1.03; 95% CI −1.29, −0.76; P < 0.05). Infection‐related adverse effects were seen more frequently with Ofatumumab shown by the odd ratio 0.48; 95% CI 0.22, 1.04; P = 0.06. Infection is, thus, a major limitation to its use.
The meta‐analysis indicated that Ofatumumab is efficacious and safe for patients with relapsing forms of multiple sclerosis.
Ofatumumab is the first monoclonal antibody developed specifically for treating relapsed multiple sclerosis (RMS). This disease (Multiple Sclerosis) includes relapsing–remitting multiple sclerosis (RRMS), a chronic autoimmune illness that affects the central nervous system (CNS), including the brain and spinal cord. The purpose of this study is to determine whether Ofatumumab is efficacious and safe in the treatment of relapsing–remitting multiple sclerosis.
An analysis of studies comparing Ofatumumab with placebo in people with relapsing‐remitting multiple sclerosis was done in accordance with PRISMA guidelines. We looked up information in MEDLINE, SciSearch, BIOSIS Previews, Derwent Drug File, Embase, and International Pharmaceutical Abstracts. In patients with relapsing–remitting multiple sclerosis, randomized double‐blind and non‐randomized trials contrasting Ofatumumab with placebo were found by two independent investigators. Utilizing Review Manager 5.4.1, data were examined. The main results were total gadolinium‐enhancing (Gd+) T1 lesions, annualized relapse rate, and new or expanding total T2 lesions. Secondary outcomes concentrated on general adverse events and adverse events related to infections.
Three studies were included involving 334 patients, and the meta‐analysis indicated that Ofatumumab showed good efficacy and safety in patients with relapsing forms of multiple sclerosis. The annual rate of relapse was significantly reduced by Ofatumumab (OR 0.51; 95% CI 0.27, 0.98; P = 0.04). Ofatumumab reduced the number of gadolinium‐enhancing (Gd+) T1 lesions per scan (Mean difference −0.59; 95% CI −0.63, −0.55; P < 0.05). Ofatumumab treatment decreased new or enlarging total T2 lesions significantly (Mean difference −1.03; 95% CI −1.29, −0.76; P < 0.05). Infection‐related adverse effects were seen more frequently with Ofatumumab shown by the odd ratio 0.48; 95% CI 0.22, 1.04; P = 0.06. Infection is, thus, a major limitation to its use.
The meta‐analysis indicated that Ofatumumab is efficacious and safe for patients with relapsing forms of multiple sclerosis.
Korn T. Pathophysiology of multiple sclerosis. J Neurol. 2008;255(6):2–6. https://doi.org/10.1007/s00415-008-6001-2
Trapp BD, Nave KA. Multiple sclerosis: an immune or neurodegenerative disorder? Annu Rev Neurosci. 2008;31(1):247–69. https://doi.org/10.1146/annurev.neuro.30.051606.094313
Wingerchuk DM, Lucchinetti CF, Noseworthy JH. Noseworthy, multiple sclerosis: current pathophysiological concepts. Lab Invest. 2001;81(3):263–81. https://doi.org/10.1038/labinvest.3780235
Gregory F, Wu EA. The immunopathophysiology of multiple sclerosis. Neurol Clin. 2011;29(2):257–78. https://doi.org/10.1016/j.ncl.2010.12.009
Johann S, Karus J, Amer A, Ron M, Bernhard H, Olaf S. The increasing incidence and prevalence of female multiple sclerosis—a critical analysis of potential environmental factors. Autoimmun Rev. 2011;10(8):495–502. https://doi.org/10.1016/j.autrev.2011.02.006
Duquette P, Pleines J, Girard M, Charest L, Senecal‐Quevillon M, Masse C. The increased susceptibility of women to multiple sclerosis. Can J Neurol Sci. 2015;19(4):466–71. https://doi.org/10.1017/S0317167100041664
Ohlmeier C, Gothe H, Haas J, Osowski U, Weinhold C, Blauwitz S, 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;15(5):e0231846. https://doi.org/10.1371/journal.pone.0231846
Kalincik T. Multiple sclerosis relapses: epidemiology, outcomes and management. A systematic review. Neuroepidemiology. 2015;44(4):199–214. https://doi.org/10.1159/000382130
Langer‐Gould A, Popat AR, Huang SM, Cobb K, Fontoura P, Gould MK, et al. Clinical and demographic predictors of long‐term disability in patients with relapsing‐remitting multiple sclerosis: a systematic review. Arch Neurol. 2006;63(12):1686–91. https://doi.org/10.1001/archneur.63.12.1686
Santos EC, Yokota M, Dias NF. Multiple sclerosis: study of patients with relapsing‐remitting form registered at Minas Gerais Secretary of State for Health. Arq Neuropsiquiatr. 2007;65(3B):885–8. https://doi.org/10.1590/s0004-282x2007000500032
Tsang BK, Macdonell R. Multiple sclerosis‐diagnosis, management and prognosis. Aust Fam Physician. 2011;40(12):948–55.
Hunter SF. Overview and diagnosis of multiple sclerosis. Am J Manag Care. 2016;22(6 Suppl l):s141–50.
Runmarker B, Andersen O. Prognostic factors in a multiple sclerosis incidence cohort with twenty‐five years of follow‐up. Brain. 1993;116(1):117–34. https://doi.org/10.1093/brain/116.1.117
Kieseier BC, Hartung HP. Current disease‐modifying therapies in multiple sclerosis. Semin Neurol. 2002;23(2):133–46. https://doi.org/10.1055/S-2003-41138
Jalkh G, Abi Nahed R, Macaron G, Rensel M. Safety of newer disease modifying therapies in multiple sclerosis. Vaccines (Basel). 2021;26(9):12. https://doi.org/10.3390/vaccines9010012
Kang C, Blair HA. Ofatumumab: a review in relapsing forms of multiple sclerosis. Drugs. 2022;82(1):55–62. https://doi.org/10.1007/s40265-021-01650-7
Bar‐Or A, Grove RA, Austin DJ, Tolson JM, VanMeter SA, Lewis EW, et al. Subcutaneous ofatumumab in patients with relapsing‐remitting multiple sclerosis: the MIRROR study. Neurology. 2018;90(20):e1805–14. https://doi.org/10.1212/WNL.0000000000005929
Kira JI, Nakahara J, Sazonov DV, Kurosawa T, Tsumiyama I, Willi R, et al. Effect of ofatumumab versus placebo in relapsing multiple sclerosis patients from Japan and Russia: phase 2 APOLITOS study. Mult Scler. 2022;28(8):1229–38. https://doi.org/10.1177/13524585211055934
Sorensen PS, Lisby S, Grove R, Derosier F, Shackelford S, Havrdova E, et al. Safety and efficacy of ofatumumab in relapsing‐remitting multiple sclerosis: a phase 2 study. Neurology. 2014;82(7):573–81. https://doi.org/10.1212/WNL.0000000000000125
Moher D, Liberati A, Tetzlaff J, Altman DG. The PRISMA Group (2010) Preferred reporting items for systematic reviews and meta‐analyses: the PRISMA statementMoher. Int J Surg. 2010;8(5):336–41. https://doi.org/10.1016/j.ijsu.2010.02.007
Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343(d5928):d5928. https://doi.org/10.1136/bmj.d5928
Boyko AN, Smirnova NF, Shchukin IA, Guseva ME, Volkov AI. Ofatumumab ‐ a new drug for the treatment of multiple sclerosis. Zh Nevrol Psikhiatr Im S S Korsakova. 2021;121(7. Vyp. 2):37–43. https://doi.org/10.17116/jnevro202112107237
Dalla Costa G, Leocani L, Comi G. Ofatumumab subcutaneous injection for the treatment of relapsing forms of multiple sclerosis. Expert Rev Clin Immunol. 2022;18(2):105–14. https://doi.org/10.1080/1744666X.2022.2031982
Flachenecker P. Disease‐modifying drugs for the early treatment of multiple sclerosis. Expert Rev Neurother. 2004;4(3):455–63. https://doi.org/10.1586/14737175.4.3.455
Lizak N, Lugaresi A, Alroughani R, Lechner‐Scott J, Slee M, Havrdova E, et al. Highly active immunomodulatory therapy ameliorates accumulation of disability in moderately advanced and advanced multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017;88(3):196–203. https://doi.org/10.1136/jnnp-2016-313976
Tramacere I, Del Giovane C, Salanti G, D'Amico R, Filippini G. Immunomodulators and immunosuppressants for relapsing‐remitting multiple sclerosis: a network meta‐analysis. Cochrane Database Syst Rev. 2015;2015(9):CD011381. https://doi.org/10.1002/14651858.CD011381
Hauser SL, Bar‐Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, et al. Ocrelizumab versus interferon beta‐1a in relapsing multiple sclerosis. N Engl J Med. 2017;376(3):221–34. https://doi.org/10.1056/NEJMoa1601277
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, et al. Natalizumab plus interferon beta‐1a for relapsing multiple sclerosis. N Engl J Med. 2006;54(9):911–23. https://doi.org/10.1056/NEJMoa044396
None.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.