Principles of a new treatment algorithm in multiple sclerosis

Expert Review of Neurotherapeutics

Volumn 11, Issue 3, 2011, Pages 351-362

  Hartung, Hans Peter ^a   Montalban, Xavier ^b   Sorensen, Per Soelberg ^c   Vermersch, Patrick ^d   Olsson, Tomas ^e  

^a UNIVERSITY HOSPITAL DÜSSELDORF   (Germany)

^b HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^c Rigshospitalet   (Denmark)

^d UNIV LILLE   (France)

^e KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

treatment algorithm

Indexed keywords

ATORVASTATIN; BETA1A INTERFERON; CLADRIBINE; CYCLOPHOSPHAMIDE; DACLIZUMAB; FINGOLIMOD; GLATIRAMER; INTERFERON BETA SERINE; METHOTREXATE; METHYLPREDNISOLONE; MINOCYCLINE; MITOXANTRONE; NATALIZUMAB; PLACEBO; RECOMBINANT BETA INTERFERON; TERIFLUNOMIDE;

ACUTE GRANULOCYTIC LEUKEMIA; ALOPECIA; ARTHRALGIA; ASTHENIA; ATRIOVENTRICULAR BLOCK; BONE MARROW SUPPRESSION; BRADYCARDIA; BRONCHITIS; CANCER RISK; CONGESTIVE HEART FAILURE; DEATH; DEPRESSION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FLU LIKE SYNDROME; FLUSHING; GASTROENTERITIS; HEART EJECTION FRACTION; HERPES SIMPLEX; HUMAN; INFECTION RISK; INJECTION SITE REACTION; LEUKOPENIA; LIPOATROPHY; LIVER TOXICITY; LYMPHOCYTOPENIA; MENSTRUATION DISORDER; MULTIPLE SCLEROSIS; MYALGIA; MYELITIS; NAUSEA; OPTIC NEURITIS; OUTCOME ASSESSMENT; PNEUMONIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RELAPSE; REMISSION; RETINA MACULA EDEMA; REVIEW; RISK REDUCTION; SIDE EFFECT; THORAX PAIN; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VASODILATATION; VIRUS INFECTION;

ADMINISTRATION, ORAL; ALGORITHMS; DISEASE PROGRESSION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MULTIPLE SCLEROSIS; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS; TREATMENT FAILURE; TREATMENT OUTCOME;

EID: 79952660229     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/ern.11.15     Document Type: Review

References (77)

1. Kuhlmann T, Lingfeld G, Bitsch A, Schuchardt J, Brück W. Acute axonal damage in multiple sclerosis is most extensive in early disease stages and decreases over time. Brain 125(Pt 10), 2202-2212 (2002)
2. Filippi M, Bozzali M, Rovaris M et al. Evidence for widespread axonal damage at the earliest clinical stage of multiple sclerosis. Brain 126(Pt 2), 433-437 (2003)
3. O'Connor P, Kinkel RP, Kremenchutzky M. Efficacy of intramuscular interferon b-1a in patients with clinically isolated syndrome: analysis of subgroups based on new risk criteria. Mult. Scler. 15(6), 728-734 (2009)
4. Kappos L, Polman CH, Freedman MS et al. Treatment with interferon b-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology 67(7), 1242-1249 (2006)
5. Comi G, Filippi M, Barkhof F et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 357(9268), 1576-1582 (2001)
6. Comi G, Martinelli V, Rodegher M et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet 374(9700), 1503-1511 (2009)
7. Jacobs LD, Beck RW, Simon JH et al. Intramuscular interferon b-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N. Engl. J. Med. 343(13), 898-904 (2000)
8. Kinkel RP, Kollman C, O'Connor P et al. IM interferon b-1a delays definite multiple sclerosis 5 years after a first demyelinating event. Neurology 66(5), 678-684 (2006)
9. Kappos L, Freedman MS, Polman CH et al. Effect of early versus delayed interferon b-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet 370(9585), 389-397 (2007)
10. 2 MRI lesions: a 20-year follow-up of patients with relapse onset of multiple sclerosis. Brain 131(Pt 3), 808-817 (2008)
11. Tintoré M, Rovira A, Río J et al. Baseline MRI predicts future attacks and disability in clinically isolated syndromes. Neurology 67(6), 968-972 (2006)
12. Brex PA, Ciccarelli O, O'Riordan JI, Sailer M, Thompson AJ, Miller DH. A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N. Engl. J. Med. 346(3), 158-164 (2002)
13. Moraal B, Pohl C, Uitdehaag BM et al. Magnetic resonance imaging predictors of conversion to multiple sclerosis in the BENEFIT study. Arch. Neurol. 66(11), 1345-1352 (2009)
14. CHAMPS Study Group. MRI predictors of early conversion to clinically definite MS in the CHAMPS placebo group. Neurology 59(7), 998-1005 (2002)
15. Le Page E, Edan G. Long-term experience with induction treatment regimens in multiple sclerosis. J. Neurol. Sci. 277, S46-S49 (2009)
16. Bogglid M. Immunosuppression followed by immunomodulation. J. Neurol. Sci. 277, S50-S54 (2009)
17. PRISMS (Prevention of Relapses and Disability by Interferon b-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon b-1a in relapsing/remitting multiple sclerosis. Lancet 352(9139), 1498-1504 (1998)
18. IFNb Multiple Sclerosis Study Group. Interferon b-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 43(4), 655-661 (1993)
19. Hartung H, Gonsette R, König N et al. Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet 360(9350), 2018-2025 (2002)
20. Polman CH, O'Connor PW, Havrdová E et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N. Engl. J. Med. 354(9), 899-910 (2006)
21. Johnson KP, Brooks BR, Cohen JA 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 45(7), 1268-1276 (1995)
22. Jacobs LD, Cookfair DL, Rudick RA et al. Intramuscular interferon b-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann. Neurol. 39(3), 285-294 (1996)
23. Neuhaus O, Kieseier BC, Hartung HP. Therapeutic role of mitoxantrone in multiple sclerosis. Pharmacol. Ther. 109, 198-209 (2006)
24. Cadavid D, Wolansky LJ, Skurnick J et al. Efficacy of treatment of MS with IFN b-1b or glatiramer acetate by monthly brain MRI in the BECOME study. Neurology 72(23), 1976-1983 (2009)
25. O'Connor P, Filippi M, Arnason B et al. 250 μg or 500 μg interferon b-1b versus 20 mg glatiramer acetate in relapsing- remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol. 8(10), 889-897 (2009)
26. Koch-Henriksen N, Sørensen PS, Christensen T et al. A randomized study of two interferon-b treatments in relapsing-remitting multiple sclerosis. Neurology 66(7), 1056-1060 (2006)
27. Panitch H, Goodin DS, Francis G et al. Randomized, comparative study of interferon b-1a treatment regimens in MS: the EVIDENCE trial. Neurology 59(10), 1496-1506 (2002)
28. Durelli L, Verdun E, Barbero P et al. Every-other-day interferon b-1b versus once-weekly interferon b-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 359(9316), 1453-1460 (2002)
29. Mikol DD, Barkhof F, Chang P et al. Comparison of subcutaneous interferon b-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 7(10), 903-914 (2008)
30. Vartanian T. An examination of the results of the EVIDENCE, INCOMIN, and Phase III studies of interferon b products in the treatment of multiple sclerosis. Clin. Ther. 25(1), 105-118 (2003)
31. Rudick RA, Stuart WH, Calabresi PA et al. Natalizumab plus interferon b-1a for relapsing multiple sclerosis. N. Engl. J. Med. 354(9), 911-923 (2006)
32. Yousry TA, Major EO, Ryschkewitsch C et al. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N. Engl. J. Med. 354(9), 924-933 (2006)
33. Clifford DB, DeLuca A, Simpson DB et al. Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases. Lancet Neurol. 9, 438-446 (2010)
34. Tyler KL. Progressive multifocal leukoencephalopathy: can we reduce risk in patients receiving biological immunomodulatory therapies? Ann. Neurol. 68(3), 271-274 (2010)
35. Warnke C, Menge T, Hartung HP et al. Natalizumab and progressive multifocal leukoencephalopathy: what are the causal factors and can it be avoided? Arch. Neurol. 67(8), 923-930 (2010)
36. Kaufman MD, Lee R, Norton H. Course of relapsing-remitting multiple sclerosis before, during and after natalizumab. Mult. Scler. DOI: 10.1177/1352458510389103 (2010) (Epub ahead of print)
37. Miravalle A, Jensen R, Kinkel RP. Immune reconstitution inflammatory syndrome in patients with multiple sclerosis following cessation of natalizumab therapy. Arch. Neurol. 68(2), 186-191 (2011)
38. Pascual AM, Téllez N, Boscá I et al. Revision of the risk of secondary leukaemia after mitoxantrone in multiple sclerosis populations is required. Mult. Scler. 15(11), 1303-1310 (2009)
39. Martinelli V, Radaelli M, Straffi L et al. Mitoxantrone: benefits and risks in multiple sclerosis patients. Neurol. Sci. 30(Suppl. 2), S167-S170 (2009)
40. Sørensen PS, Deisenhammer F, Duda P et al. Guidelines on use of anti-IFN-b antibody measurements in multiple sclerosis: report of an EFNS task force on IFN-b antibodies in multiple sclerosis. Eur. J. Neurol. 12(11), 817-827 (2005)
41. Polman CH, Bertolotto A, Deisenhammer F et al. Recommendations for clinical use of data on neutralising antibodies to interferon-b therapy in multiple sclerosis. Lancet Neurol. 9(7), 740-750 (2010)
42. Simon JA, Lewiecki EM, Smith ME, Petruschke RA, Wang L, Palmisano JJ. Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomized, open-label, crossover study. Clin. Ther. 24(11), 1871-1886 (2002)
43. Ettinger MP, Gallagher R, MacCosbe PE. Medication persistence with weekly versus daily doses of orally administered bisphosphonates. Endocr. Pract. 12(5), 522-528 (2006)
44. Aktas O, Küry P, Kieseier BC et al. Fingolimod is a potential novel therapy for multiple sclerosis. Nat. Rev. Neurol. 6, 373-382 (2010)
45. Brinkmann V, Billich A, Baumruker T et al. Fingolimod (FTY720): discovery and development of an oral drug to treat multiple sclerosis. Nat. Rev. Drug Discov. 9(11), 883-897 (2010)
46. Kappos L, Radue E, O'Connor P et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N. Engl. J. Med. 362(5), 387-401 (2010)
47. Cohen JA, Barkhof F, Comi G et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N. Engl. J. Med. 362(5), 402-415 (2010)
48. Giovannoni G, Comi G, Cook S et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N. Engl. J. Med. 362(5), 416-426 (2010)
49. Marcén R. Immunosuppressive drugs in kidney transplantation: impact on patient survival, and incidence of cardiovascular disease, malignancy and infection. Drugs 69(16), 2227-2243 (2009)
50. Warnke C, Hörste GM, Hartung HP et al. Review of teriflunomide and its potential in the treatment of multiple sclerosis. Neuropsychiatr. Dis. Treat. 5, 333-340 (2009)
51. O'Connor P, Wolinsky J, Confavreux C et al. A placebo-controlled Phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis: clinical efficacy and safety outcomes. Presented at: European Committee for Treatment and Research in Multiple Sclerosis. Göteborg, Sweden, 13-16 October, 2010
52. Wolinsky J, O'Connor P, Confavreux C et al. A placebo-controlled Phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis: magnetic resonance imaging (MRI) outcomes. Presented at: European Committee for Treatment and Research in Multiple Sclerosis. Göteborg, Sweden, 13-16 October 2010
53. Hartung HP, Aktas O. Oral therapies for multiple sclerosis: are we there yet? Lancet Neurol. 9, 454-457 (2010)
54. Gorelik L, Lerner M, Bixler S et al. Anti-JC virus antibodies: implications for PML risk stratification. Ann. Neurol. 68(3), 295-303 (2010)
55. Limmroth V, Malessa R, Zettl UK et al. Quality Assessment in Multiple Sclerosis Therapy (QUASIMS): a comparison of interferon b therapies for relapsing-remitting multiple sclerosis. J. Neurol. 254(1), 67-77 (2007)
56. Carrá A, Onaha P, Luetic G et al. Therapeutic outcome 3 years after switching of immunomodulatory therapies in patients with relapsing-remitting multiple sclerosis in Argentina. Eur. J. Neurol. 15(4), 386-393 (2008)
57. Gajofatto A, Bacchetti P, Grimes B, High A, Waubant E. Switching first-line disease-modifying therapy after failure: impact on the course of relapsing-remitting multiple sclerosis. Mult. Scler. 15(1), 50-58 (2009)
58. Cohen JA, Imrey PB, Calabresi PA et al. Results of the Avonex Combination Trial (ACT) in relapsing-remitting MS. Neurology 72(6), 535-541 (2009)
59. Lanzillo R, Orefice G, Quarantelli M et al. Atorvastatin combined to interferon to verify the efficacy (ACTIVE) in relapsing-remitting active multiple sclerosis patients: a longitudinal controlled trial of combination therapy. Mult. Scler. 16(4), 450-454 (2010)
60. Wynn D, Kaufman M, Montalban X et al. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a Phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon b. Lancet Neurol. 9(4), 381-390 (2010)
61. Metz LM, Li D, Traboulsee A et al. Glatiramer acetate in combination with minocycline in patients with relapsing-remitting multiple sclerosis: results of a Canadian, multicenter, double-blind, placebo-controlled trial. Mult. Scler. 15(10), 1183-1194 (2009)
62. Goodman AD, Rossman H, Bar-Or A et al. GLANCE: results of a Phase 2, randomized, double-blind, placebo-controlled study. Neurology 72(9), 806-812 (2009)
63. Smith DR, Weinstock-Guttman B, Cohen JA et al. A randomized blinded trial of combination therapy with cyclophosphamide in patients with active multiple sclerosis on interferon b. Mult. Scler. 11(5), 573-582 (2005)
64. Sørensen PS, Mellgren SI, Svenningsson A et al. NORdic trial of oral Methylprednisolone as add-on therapy to Interferon b-1a for treatment of relapsing-remitting multiple sclerosis (NORMIMS study): a randomised, placebo-controlled trial. Lancet Neurol. 8(6), 519-529 (2009)
65. Ravnborg M, Sørensen PS, Andersson M et al. Methylprednisolone in combination with interferon b-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial. Lancet Neurol. 9(7), 672-680 (2010)
66. Havrdová E, Galetta S, Hutchinson M et al. Effect of natalizumab on clinical and radiological disease activity in multiple sclerosis: a retrospective analysis of the Natalizumab Safety and Efficacy in Relapsing-Remitting Multiple Sclerosis (AFFIRM) study. Lancet Neurol. 8(3), 254-260 (2009)
67. Oturai AB, Koch-Henriksen N, Petersen T, Jensen PE, Sellebjerg F, Sørensen PS. Efficacy of natalizumab in multiple sclerosis patients with high disease activity: a Danish nationwide study. Eur. J. Neurol. 16(3), 420-423 (2009)
68. Belachew S, Phan-Ba R, Bartholomé E et al. Natalizumab induces a rapid improvement of disability status and ambulation after failure of previous therapy in relapsing-remitting multiple sclerosis. Eur. J. Neurol. 18(2), 240-245 (2011)
69. Putzki N, Yaldizli O, Mäurer M et al. Efficacy of natalizumab in second line therapy of relapsing-remitting multiple sclerosis: results from a multi-center study in German speaking countries. Eur. J. Neurol. 17(1), 31-37 (2010)
70. Sangalli F, Moiola L, Bucello S et al. Efficacy and tolerability of natalizumab in relapsing-remitting multiple sclerosis patients: a post-marketing observational study. Neurol. Sci. DOI: 10.1007/ s10072-010-0344-z (2010) (Epub ahead of print)
71. Piehl F, Holmén C, Hillert J, Olsson T. Swedish natalizumab (Tysabri) multiple sclerosis surveillance study. Neurol. Sci. DOI: 10.1007/s10072-010-0345-y (2010) (Epub ahead of print)
72. Prosperini L, Borriello G, Fubelli F, Marinelli F, Pozzilli C. Natalizumab treatment in multiple sclerosis: the experience of S. Andrea MS Centre in Rome. Neurol. Sci. DOI: 10.1007/ s10072-010-0348-8 (2010) (Epub ahead of print)
73. Aktas O, Kieseier BC, Hartung HP. Neuroprotection, regeneration and immunomodulation: broadening the therapeutic repertoire in multiple sclerosis. Trends Neurosci. 33(3), 140-152 (2009)
74. Kappos L, Gold R, Miller DH et al. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled Phase IIb study. Lancet 372(9648), 1463-1472 (2008)
75. Comi G, Pulizzi A, Rovaris M et al. Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled Phase IIb study. Lancet 371(9630), 2085-2092 (2008)
76. Baker DP, Pepinsky RB, Brickelmaier M et al. PEGylated interferon b-1a: meeting an unmet medical need in the treatment of relapsing multiple sclerosis. J. Interferon Cytokine Res. 30(10), 777-785 (2010)
77. CAMMS223 Trial Investigators. Alemtuzumab vs interferon b-1a in early multiple sclerosis. N. Engl. J. Med. 359(17), 1786-1801 (2008)