Recommendations for optimising the treatment of multiple sclerosis in Latin America;Recomendaciones para la optimización del tratamiento de la esclerosis múltiple en Latinoamérica

Revista de Neurologia

Volumn 44, Issue 8, 2007, Pages 494-498

  Cristiano, E ^a   Arcega, R ^c   Correale, J ^b   Gabbay, A A ^d   Lander Delgado, R ^e   Macias Islas M A ^g   Palacios, E ^h   Patrucco, Liliana ^a   Rivera Olmos, V ⁱ   Soto, A ^f  

^a HOSPITAL ITALIANO DE BUENOS AIRES   (Argentina)

^b Instituto de Investigaciones Neurologicas Raul Carrera   (Argentina)

^c HOSPITAL DE ESPECIALIDADES   (Mexico)

^d FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

^e Centro Medico Docente La Trinidad   (Venezuela)

^f Hospital Dr Domingo Luciani   (Venezuela)

^g INSTITUTO MEXICANO DEL SEGURO SOCIAL   (Mexico)

^h HOSPITAL DE SAN JOSÉ   (Colombia)

ⁱ BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

Immunomodulators; Mitoxantrone; Multiple sclerosis; Neutralising antibodies; Therapeutic failure; Treatment

Indexed keywords

BETA1A INTERFERON; GLATIRAMER; IMMUNOMODULATING AGENT; INTERFERON BETA SERINE; MITOXANTRONE; IMMUNOLOGIC FACTOR;

CLINICAL TRIAL; DRUG MECHANISM; HUMAN; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; REVIEW; CONFERENCE PAPER; CONSENSUS DEVELOPMENT; HEALTH CARE PLANNING; HEALTH SERVICE; SOUTH AND CENTRAL AMERICA; TREATMENT OUTCOME;

HEALTH PLANNING GUIDELINES; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; IMMUNOLOGIC FACTORS; LATIN AMERICA; MULTIPLE SCLEROSIS; TREATMENT OUTCOME;

EID: 34848844702     PISSN: 02100010     EISSN: None     Source Type: Journal    
DOI: 10.33588/rn.4408.2006466     Document Type: Review

References (62)

1. Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology 1996; 46: 907-11.
2. Rosati G. The prevalence of multiple sclerosis in the world: an update. Neurol Sci 2001; 22: 117-39.
3. Pugliatti M, Sotgiu S, Rosati G. The worldwide prevalence of multiple sclerosis. Clin Neurol Neurosurg 2002; 104: 182-91.
4. McDonald WI, Compston A, Edan G, Goodkin D, Hartung HP, Lublin F, et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the Diagnosis of Multiple Sclerosis. Ann Neurol 2001; 50: 121-7.
5. Poser CM, Paty DW, Scheinberg L, McDonald WI, Davis FA, Ebers GC, et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Ann Neurol 1983; 13: 227-31.
6. Gasperini C. Differential diagnosis in multiple sclerosis. Neurol Sci 2001; 22: S93-7.
7. Miller D, Barkhof F, Montalbán X, Thompson A, Filippi M. Clinically isolated syndromes suggestive of multiple sclerosis. Part I: natural history, pathogenesis, diagnosis and prognosis. Lancet Neurol 2005; 4: 281-8.
8. Frohman EM, Goodin DS, Calabresi PA, Corboy JR, Coyle PK, Filippi M, et al. The utility of MRI in suspected MS: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2003; 61: 602-11.
9. Barkhof F, Filippi M, Miller DH, Scheltens P, Campi A, Polman CH, et al. Comparison of MRI criteria at first presentation to predict conversion to clinically definite multiple sclerosis. Brain 1997; 120: 2059-69.
10. Tintoré M, Rovira A, Martínez MJ, Río J, Díaz-Villoslada P, Brieva L, et al. Isolated demyelinating syndromes: comparison of different MR imaging criteria to predict conversion to clinically definite multiple sclerosis. AJNR Am J Neuroradiol 2000; 21: 702-6.
11. Miller D, Barkhof F, Montalbán X, Thompson A, Filippi M. Clinically isolated syndromes suggestive of multiple sclerosis. Part II: non-conventional MRI, recovery processes and management. Lancet Neurol 2005; 4: 341-8.
12. O'Riordan JI, Thompson AJ, Kingsley DP, MacManus DG, Kendall BE, Rudge P, et al. The prognostic value of brain MRI in clinically isolated syndromes of the CNS. A 10-years follow-up. Brain 1998; 121: 495-503.
13. Runmarker B, Andersen O. Prognostic factors in a multiple sclerosis incidence cohort with twenty-five years of follow-up. Brain 1993; 116: 117-34.
14. Tintoré M, Riovira A, Brieva L, Grive E, Jardí R, Borrás C, et al. Isolated demyelinating syndromes: comparison of CSF ologoclonal bands and different MR imaging criteria to predict conversion to CDMS. Mult Scler 2001; 7: 359-63.
15. Gronsett GS, Ashman EJ. Practice parameter: the usefulness of evoked potentials in identifying clinically silent lesions in patients with suspected multiple sclerosis (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000; 54: 1720-5.
16. Kappos L, Polman C, Freedman MS, Edan GC, Hartung HP, Millar X, et al. Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT): clinical results [abstract]. Mult Scler 2005; 11: S10.
17. Jacobs LD, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med 2000; 343: 898-904.
18. Comi G, Filippi M, Barkhof F, Durelli L, Edan G, Fernández O, et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomized study. Lancet 2001; 357: 1576-82.
19. Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon beta-1a in MS (SPECTRIMS) Study Group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: clinical results. Neurology 2001; 56: 1496-504.
20. Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Kooijmans MF, et al. Benefit of interferon beta-1a on MSFC progression in secondary progressive MS. Neurology 2002; 59: 679-87.
21. European Study Group on Interferon β-1b in Secondary Progressive MS. Placebo-controlled multicentre randomised trial of interferon β-1b in treatment of secondary progressive multiple sclerosis. Lancet 1998; 352: 1491-7.
22. Panitch H, Miller A, Paty D, Weinshenker B. North American Study Group on Interferon beta-1b in Secondary Progressive MS. Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study. Neurology 2004; 63: 1788-95.
23. Does interferon beta help in secondary progressive MS? [editorial]. Neurology 2004; 63: 1768-9.
24. Jacobs LD, Cookfair DL, Rudick RA, Herndon RM, Richert JR, Salazar AM, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurol 1996; 39: 285-94.
25. PRISMS Study Group. Randomised double-blind, placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-504.
26. IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993; 43: 655-61.
27. Johnson KP, Brooks BR, Cohen JA, Ford CC, Goldstein J, Lisak RP, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995; 45: 1268-76.
28. Ferguson B, Matyszak MK, Esiri MM, Perry VH. Axonal damage in acute multiple sclerosis lesions. Brain 1997; 120: 393-9.
29. Trapp BD, Peterson J, Ransohoff RM, Rudick R, Mork S, Bo L. Axonal transection in the lesions of multiple sclerosis. N Engl J Med 1998; 338: 278-85.
30. De Stefano N, Narayanan S, Francis GS, Arnaoutelis R, Tartaglia MC, Antel JP, et al. Evidence of axonal damage in the early stages of multiple sclerosis and its relevance to disability. Arch Neurol 2001; 58: 65-70.
31. Kappos L, Traboulsee A, Constantinescu C, Eralinna JP, Forrestal F, Jongen P, et al. Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS. Neurology. 2006; 67: 944-53.
32. Kinkel RP, Kollman C, O'Connor P, Murray TJ, Simon J, Arnold D, et al. CHAMPIONS Study Group. IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event. Neurology 2006 Mar 14; 66: 678-84.
33. Freedman MS, Patry DG, Grand'Maison F, Myles ML, Paty DW, Selchen DH, Canadian MS Working Group. Treatment optimization in multiple sclerosis. Can J Neurol Sci 2004; 31: 157-68.
34. International Working Group for Treatment Optimization in MS. Treatment optimization in multiple sclerosis: report of an international consensus meeting. Eur J Neurol 2004; 11: 43-7.
35. Comi G, Filippi M,Wolinsky JS, European/Canadian Glatiramer Acetate Study Group. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging: measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol 2001; 49: 290-7.
36. Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, et al. Randomized comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE Trial. Neurology 2002; 59: 1496-506.
37. Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002; 359: 1453-60.
38. Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, et al, EVIDENCE (Evidence of Interferon Dose-Response: European North American Comparative Efficacy) Study Group. University of British Columbia MS/MRI Research Group. Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study. Arch Neurol 2005; 62: 785-92.
39. Yong VW. Differential mechanisms of action of interferon-beta and glatiramer acetate in MS. Neurology 2002; 59: 802-8.
40. Dhib-Jalbut S. Mechanisms of action of interferons and glatiramer acetate in multiple sclerosis. Neurology 2002; 58: S3-9.
41. Zhao GJ, Koopmans RA, Li DK, Bedell L, Paty DW. Effect of interferon beta-1b in MS: assessment of annual accumulation of PD/T2 activity on MRI. UBC MS/MRI Analysis Group and the MS Study Group. Neurology 2002; 54: 200-6.
42. Barbero P, Verdun E, Bergui M, Pipieri A, Clerico M, Cucci A, et al. High-dose, frequently administered interferon beta therapy for relapsing-remitting multiple sclerosis must be maintained over the long term: the interferon beta dose-reduction study. J Neurol Sci 2004; 222: 13-9.
43. Francis GS, Rice GP, Alsop JC, PRISMS Study Group. Interferon beta-1a in MS: results following development of neutralizing antibodies in PRISMS. Neurology 2005; 65: 48-55.
44. Kappos L, Clanet M, Sandberg-Wollheim M, Radue EW, Hartung HP, Holfeld R, et al, European Interferon Beta-1a IM Dose-Comparison Study Investigators. Neutralizing antibodies and efficacy of interferon beta-1a: a 4-year controlled study. Neurology 2005; 65: 40-7.
45. Giovannoni G, Goodman A. Neutralizing anti-IFN-beta antibodies: how much more evidence do we need to use them in practice? Neurology 2005; 65: 6-8.
46. Avonex® (interferon beta-1a) package insert. Biogen Inc; 02/03.
47. Betaseron® (interferon beta-1b) package insert. Berlex Laboratories; 04/03.
48. Copaxone® (glatiramer acetate injection) package insert. Teva Neuroscience Inc; 01/02.
49. Rebif® (interferon beta-1a) package insert. Serono Inc; June 2003.
50. Galetta SL, Markowitz C. US FDA-approved disease-modifying treatments for multiple sclerosis: review of adverse effect profiles. CNS Drugs 2005; 19: 239-52.
51. Rizvi SA, Agius MA. Current approved options for treating patients with multiple sclerosis. Neurology 2004; 63; S8-14.
52. Cohen BA, Mikol DD. Mitoxantrone treatment of multiple sclerosis: safety considerations. Neurology 2004; 63: S28-32.
53. Rizvi SA, Zwibel H, Fox EJ. Mitoxantrone for multiple sclerosis in clinical practice. Neurology 2004; 63: S25-7.
54. Jeffrey DR, Herndon R. Review of mitoxantrone in the treatment of multiple sclerosis. Neurology 2004; 63: S19-24.
55. Correale J, Rush C, Amengual A, Goicochea MT. Mitoxantrone as rescue therapy in worsening relapsing-remitting MS patients receiving IFN-beta. J Neuroimmunol 2005; 162: 173-83.
56. Hartung HP, Gonsette R, Konig N, Kwiecinski H, Guseo A, Morrisey SP, et al, Mitoxantrone in Multiple Sclerosis Study Group (MIMS). Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet 2002; 360: 2018-25.
57. Edan G, Miller D, Clanet M, Confavreux C, Lyon-Caen O, Lubetzki C, et al. Therapeutic effect of mitoxantrone combined with methylprednisolone in multiple sclerosis: a randomised multicentre study of active disease using MRI and clinical criteria. J Neurol Neurosurg Psychiatry 1997; 62: 112-8.
58. Rudick RA, Cohen JA, Weinstock-Guttman B, Kinkel RP, Ransohoff RM. Management of multiple sclerosis. N Engl J Med 1997; 337: 1604-11.
59. European Medicines Agency. Guideline on similar biological medicinal products. URL: http://www.emea.eu.int/pdfs/human/biosimilar/ewp/309702en.pdf. [20.12.2004].
60. European Medicines Agency. Guidance on Comparability of Medicinal products containing biotechnology-derived proteins as active substance -non clinical and clinical issues. URL: http://www.emea.eu.int/pdfs/human/ewp/ 309702en.pdf. [17.12.2003].
61. Schellekens H. When biotech proteins go off-patent. Trends Biotechnol 2004; 22: 406-10.
62. Combe C, Tredree RL, Schellekens H. Biosimilar epoetins: an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy 2005; 25: 954-62.