Is there a change of paradigm towards more effective treatment early in the course of apparent high-risk MS?

Multiple Sclerosis and Related Disorders - Tập 17 - Trang 75-83 - 2017
Óscar Fernández1
1Fundación IMABIS, Hospital Regional Universitario Carlos Haya, Avenida de Carlos Haya sn, Málaga 29010, Spain

Tài liệu tham khảo

Awad, 2009, Cyclophosphamide in multiple sclerosis: scientific rationale, history and novel treatment paradigms, Ther. Adv. Neurol. Disord., 2, 50, 10.1177/1756285609344375 Idec Biogen, 2013. TYSABRI (natalizumab) injection, for intravenous use. Prescribing Information. Available at: 〈http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s033lbl.pdf〉. (Accessed 8 June 2016). Biogen Idec Limited. TYSABRI SmPC. Available at:〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000603/WC500044686.pdf〉. (Accessed 8 June 2016). Brinkmann, 2002, The immune modulator FTY720 targets sphingosine 1-phosphate receptors, J. Biol. Chem., 277, 21453, 10.1074/jbc.C200176200 Calabresi, 2014, Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial, Lancet Neurol., 13, 545, 10.1016/S1474-4422(14)70049-3 Callegaro D., Krieger S., Arnold D.L., Coles A.J., Hartung H.P., Havrdova E. et al. 2014. Superior efficacy with alemtuzumab compared with subcutaneous interferon beta-1a in highly active relapsing-remitting multiple sclerosis patients who relapsed on a prior therapy. In: Proceedings of the 8th Latin American Committee for Treatment and Research in Multiple Sclerosis (LACTRIMS) Meeting. Lima, Peru. Capobianco, 2012, Natalizumab in aggressive multiple sclerosis after haematopoietic stem cell transplantation, Neurol. Sci., 33, 863, 10.1007/s10072-011-0848-1 Chataway, 2013, Natalizumab therapy for multiple sclerosis, Neurotherapeutics, 10, 19, 10.1007/s13311-012-0171-4 Cohen, 2010, Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis, N. Engl. J. Med., 362, 402, 10.1056/NEJMoa0907839 Cohen, 2012, Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial, Lancet, 380, 1819, 10.1016/S0140-6736(12)61769-3 Coles, 2016, Alemtuzumab provides durable improvements in clinical outcomes in treatment-naive patients with active relapsing-remitting multiple sclerosis over 6 years in the absence of continuous treatment (care-MS I), Mult. Scler. J., 22, P213 Coles, 2008, Alemtuzumab vs. interferon beta-1a in early multiple sclerosis, N. Engl. J. Med., 359, 1786, 10.1056/NEJMoa0802670 Coles, 2012, Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial, Lancet, 380, 1829, 10.1016/S0140-6736(12)61768-1 Comi, 2016, Durable effect of alemtuzumab on MRI lesion outcomes over 5 years in patients with highly active relapsing-remitting multiple sclerosis who had an inadequate response to prior therapy (care-MS II), Mult. Scler. J., 22, P613 Confavreux, 2012, Efficacy of alemtuzumab in relapsing-remitting multiple sclerosis (RRMS) patients with highly active disease despite therapy, Eur. J. Neurol., 19, Suppl 1 Confavreux, 2003, Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process, Brain, 126, 770, 10.1093/brain/awg081 Cox, 2005, Lymphocyte homeostasis following therapeutic lymphocyte depletion in multiple sclerosis, Eur. J. Immunol., 35, 3332, 10.1002/eji.200535075 Dendrou, 2015, Immunopathology of multiple sclerosis, Nat. Rev. Immunol., 15, 545, 10.1038/nri3871 Derfuss, 2015, Efficacy of fingolimod in patients with highly active relapsing-remitting multiple sclerosis, Curr. Med. Res. Opin., 31, 1687, 10.1185/03007995.2015.1067191 Devonshire, 2012, Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study, Lancet Neurol., 11, 420, 10.1016/S1474-4422(12)70056-X EMD Serono Inc, 2008. NOVANTRONE Prescribing Information. Available at: 〈http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf〉. (Accessed 30 September 2016). EMD Serono Inc, 2016. NOVANTRONE SmPC. Available at: 〈http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Novantrone_30/WC500205489.pdf〉. (Accessed 30 September 2016). Fox, 2016, Efficacy of alemtuzumab is durable over 6 years in patients with active relapsing-remitting multiple sclerosis and an inadequate response to prior therapy in the absence of continuous treatment (care-MS II), Mult. Scler. J., 22, P1150 Freedman, 2014, Moving toward earlier treatment of multiple sclerosis: findings from a decade of clinical trials and implications for clinical practice, Mult. Scler. Relat. Disord., 3, 147, 10.1016/j.msard.2013.07.001 Genzyme Corporation, 2014. November 2014. LEMTRADA (alemtuzumab), for intravenous injection. Prescribing Information. Available at: 〈http://www.fda.gov/downloads/drugs/drugsafety/ucm426512.pdf〉. (Accessed 11 February 2016). Genzyme Therapeutics Ltd, 2015. LEMTRADA (alemtuzumab) SmPC. Available at: 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003718/WC500150521.pdf〉. (Accessed 2 September 2015). Giovannoni, 2016, Switching patients at high risk of PML from natalizumab to another disease-modifying therapy, Pract. Neurol., 16, 389, 10.1136/practneurol-2015-001355 Goodin, D.S., Arnason, B.G., Coyle, P.K., Frohman, E.M., Paty, D.W., Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology, 2003. The use of mitoxantrone (Novantrone) for the treatment of multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 61, pp. 1332–1338. Hartung, 2015, Alemtuzumab: a new therapy for active relapsing-remitting multiple sclerosis, Mult. Scler., 21, 22, 10.1177/1352458514549398 Hill-Cawthorne, 2012, Long term lymphocyte reconstitution after alemtuzumab treatment of multiple sclerosis, J. Neurol. Neurosurg. Psychiatry, 83, 298, 10.1136/jnnp-2011-300826 Hirst, 2008, Campath 1-H treatment in patients with aggressive relapsing remitting multiple sclerosis, J. Neurol., 255, 231, 10.1007/s00415-008-0696-y Hu, 2009, Investigation of the mechanism of action of alemtuzumab in a human CD52 transgenic mouse model, Immunology, 128, 260, 10.1111/j.1365-2567.2009.03115.x Hutchinson, 2009, The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL, J. Neurol., 256, 405, 10.1007/s00415-009-0093-1 Kappos, 2010, A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis, N. Engl. J. Med., 362, 387, 10.1056/NEJMoa0909494 Khatri, 2016, Fingolimod in the treatment of relapsing-remitting multiple sclerosis: long-term experience and an update on the clinical evidence, Ther. Adv. Neurol. Disord., 9, 130, 10.1177/1756285616628766 Kornek, 2015, An update on the use of natalizumab in the treatment of multiple sclerosis: appropriate patient selection and special considerations, Patient Prefer Adherence, 9, 675, 10.2147/PPA.S20791 Krieger S., Arnold D.L., Cohen J., Coles A.J., Fox E.J., Hartung H.P., et al. 2013. Alemtuzumab is efficacious in highly active RRMS patients in CARE-MS II. Joint Consortium of Multiple Sclerosis Centers (CMSC)/Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting. Orlando, FL. May 29-June 1. Krieger S., Lubetzki C., Arnold D.L., Fisher E., Palmer J., Margolin D.H., 2014. Alemtuzumab reduces disease activity in treatment-naive patients with highly active relapsing-remitting multiple sclerosis. In: Proceedings of the Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)–European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Meeting. Boston, MA. September 10–13. Krieger, 2016, Treatment-naive patients with highly active RRMS demonstrated durable efficacy with alemtuzumab over 5 years, Neurology, 86 Krishnan, 2008, Reduction of disease activity and disability with high-dose cyclophosphamide in patients with aggressive multiple sclerosis, Arch. Neurol., 65, 1044, 10.1001/archneurol.65.8.noc80042 Le Page, 2015, Alemtuzumab as rescue therapy in a cohort of 16 aggressive multiple sclerosis patients previously treated by Mitoxantrone: an observational study, J. Neurol., 262, 1024, 10.1007/s00415-015-7653-3 Le Page, 2008, Mitoxantrone as induction treatment in aggressive relapsing remitting multiple sclerosis: treatment response factors in a 5 year follow-up observational study of 100 consecutive patients, J. Neurol. Neurosurg. Psychiatry, 79, 52, 10.1136/jnnp.2007.124958 Mandala, 2002, Alteration of lymphocyte trafficking by sphingosine-1-phosphate receptor agonists, Science, 296, 346, 10.1126/science.1070238 Martinelli Boneschi, 2013, Mitoxantrone for multiple sclerosis, Cochrane Database Syst. Rev., 5, CD002127 Matloubian, 2004, Lymphocyte egress from thymus and peripheral lymphoid organs is dependent on S1P receptor 1, Nature, 427, 355, 10.1038/nature02284 McGuigan, 2016, Stratification and monitoring of natalizumab-associated progressive multifocal leukoencephalopathy risk: recommendations from an expert group, J. Neurol. Neurosurg. Psychiatry, 87, 117 Medicines and Healthcare Products Regulatory Agency, 2016. Fingolimod (Gilenya): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections. Available at: 〈https://www.gov.uk/drug-safety-update/fingolimod-gilenya-risks-of-progressive-multifocal-leukoencephalopathy-basal-cell-carcinoma-and-opportunistic-infections〉. (Accessed 20 September 2016). Menon, 2013, Characterising aggressive multiple sclerosis, J. Neurol. Neurosurg. Psychiatry, 84, 1192, 10.1136/jnnp-2013-304951 Novartis Europharm Ltd, 2015. GILENYA Summary of Product Characteristics. Available at: 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002202/WC500104528.pdf〉. (Accessed 5 October 2016). Novartis Pharmaceuticals Corporation, 2016. GILENYA (fingolimod). Prescribing information. Available at: 〈https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/gilenya.pdf〉. (Accessed 30 September 2016). O'Riordan, 1998, The prognostic value of brain MRI in clinically isolated syndromes of the CNS. A 10-year follow-up, Brain, 121, 495, 10.1093/brain/121.3.495 Pascual, 2009, Revision of the risk of secondary leukaemia after mitoxantrone in multiple sclerosis populations is required, Mult. Scler., 15, 1303, 10.1177/1352458509107015 Perini, 2007, The safety profile of cyclophosphamide in multiple sclerosis therapy, Expert Opin. Drug Saf., 6, 183, 10.1517/14740338.6.2.183 Polman, 2006, A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis, N. Engl. J. Med., 354, 899, 10.1056/NEJMoa044397 Rao, 2012, Human peripheral blood mononuclear cells exhibit heterogeneous CD52 expression levels and show differential sensitivity to alemtuzumab mediated cytolysis, PLoS One, 7, e39416, 10.1371/journal.pone.0039416 Rinaldi, 2009, Cyclophosphamide as second-line therapy in multiple sclerosis: benefits and risks, Neurol. Sci., 30, S171, 10.1007/s10072-009-0145-4 Rudick, 2006, Significance of T2 lesions in multiple sclerosis: a 13-year longitudinal study, Ann. Neurol., 60, 236, 10.1002/ana.20883 Rudick, 2006, Natalizumab plus interferon beta-1a for relapsing multiple sclerosis, N. Engl. J. Med., 354, 911, 10.1056/NEJMoa044396 Rush, 2015, Aggressive multiple sclerosis: proposed definition and treatment algorithm, Nat. Rev. Neurol., 11, 379, 10.1038/nrneurol.2015.85 Sanofi Genzyme, 2013. Data on File. Scott, 2000, Short-term prognosis in early relapsing-remitting multiple sclerosis, Neurology, 55, 689, 10.1212/WNL.55.5.689 Singer, 2016, Patients who had highly active RRMS and an inadequate response to prior therapy demonstrated durable efficacy with alemtuzumab: 5-year follow-up of the care-MS II study, Neurology, 86 Sorensen, 2014, New management algorithms in multiple sclerosis, Curr. Opin. Neurol., 27, 246, 10.1097/WCO.0000000000000096 Subei, 2015, Risk mitigation strategies for adverse reactions associated with the disease-modifying drugs in multiple sclerosis, CNS Drugs, 29, 759, 10.1007/s40263-015-0277-4 Thompson, 2010, B-cell reconstitution and BAFF after alemtuzumab (Campath-1H) treatment of multiple sclerosis, J. Clin. Immunol., 30, 99, 10.1007/s10875-009-9327-3 Tintore, 2015, Defining high, medium and low impact prognostic factors for developing multiple sclerosis, Brain, 138, 1863, 10.1093/brain/awv105 Weiner, 2009, The challenge of multiple sclerosis: how do we cure a chronic heterogeneous disease?, Ann. Neurol., 65, 239, 10.1002/ana.21640 Zhang, 2013, Differential reconstitution of T cell subsets following immunodepleting treatment with alemtuzumab (anti-CD52 monoclonal antibody) in patients with relapsing-remitting multiple sclerosis, J. Immunol., 191, 5867, 10.4049/jimmunol.1301926 Ziemssen, 2015, Optimizing therapy early in multiple sclerosis: an evidence-based view, Mult. Scler. Relat. Disord., 4, 460, 10.1016/j.msard.2015.07.007