Effect of mitoxantrone on MRI in progressive MS: Results of the MIMS trial

Neurology

Volumn 65, Issue 5, 2005, Pages 690-695

  Krapf, Hilmar ^a   Morrissey, S P ^b,c   Zenker, O ^c   Zwingers, T ^d   Gonsette, R ^e   Hartung, H P ^b,f  

^a UNIVERSITY OF TÜBINGEN   (Germany)

^b UNIVERSITY OF WÜRZBURG   (Germany)

^c Wyeth Pharma GmbH   (Germany)

^d Fa Estimate GmbH Augsburg   (Germany)

^e National Multiple Sclerosis Center   (Belgium)

^f HEINRICH HEINE UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

GADOLINIUM; MITOXANTRONE; PLACEBO;

ADULT; ARTICLE; CLINICAL TRIAL; CONTRAST ENHANCEMENT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; REMISSION; TREATMENT OUTCOME;

EID: 24644485224     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/01.wnl.0000174439.70369.7a     Document Type: Article

References (70)

1. Gonsette RE, Demonty L. Immunosuppression with mitoxantrone in multiple sclerosis: a pilot study for 2 years in 22 patients. Neurology 2001;40(suppl 1):A261. Abstract.
2. Kappos L, Gold R, Künstler E. Mitoxantrone in the treatment of rapidly progressive multiple sclerosis: a pilot study with serial gadolinium-enhanced MRI. Neurology 2001;40(suppl 1):A261. Abstract.
3. Mauch E, Kornhuber HH, Krapf H, Fetzer U, Laufen H. Treatment of multiple sclerosis with mitoxantrone. Eur Arch Psychiatry Clin Neurosci 1992;242:96-102.
4. Noseworthy JH, Hopkins MB, Vandervoort MK, et al. An open-trial evaluation of mitoxantrone in the treatment of progressive MS. Neurology 1993;43:1401-1406.
5. Ruggero C, Marciano N. Mitoxantrone therapy of secondary progressive multiple sclerosis: a pilot study. Neurology 2001;43(suppl 2):A494. Abstract.
6. Edan G, Miller D, Clanet M, 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;62:112-118.
7. Millefiorini E, Gasperini C, Pozzilli C, et al. Randomized placebo-controlled trial of mitoxantrone in relapsing-remitting multiple sclerosis: 24-month clinical and MRI outcome. J Neurol 1997;244:153-159.
8. Reeß J, Eisenmann S, Mauch E, et al. Results of an open study with 75 MS patients treated with mitoxantrone. Mult Scler 2001;4:382. Abstract.
9. Mesaros S, Levic Z, Drulovic J. Treatment of multiple sclerosis with mitoxantrone. Mult Scler 2001;4:387. Abstract.
10. Debouverie M, Vandenberghe N, Morrissey SP, et al. Predictive parameters of mitoxantrone effectiveness in the treatment of multiple sclerosis. Mult Scler 2004;10:407-412.
11. Krapf H, Mauch E, Fetzer U, Laufen H, Kornhuber HH. Serial gadolinium-enhanced magnetic resonance imaging in patients with multiple sclerosis treated with mitoxantrone. Neuroradiology 1995;37: 113-119.
12. Edan G, Morrissey SP, Hartung HP. Use of mitoxantrone to treat multiple sclerosis. In: Cohen JA, Rudick RA, eds. Multiple sclerosis therapeutics, 2nd ed. London: Martin Dunitz, 2003;403-427.
13. Lenk H, Muller U, Tanneberger S. Mitoxantrone: mechanism of action, antitumor activity, pharmacokinetics, efficacy in the treatment of solid tumors and lymphomas, and toxicity. Anticancer Res 1987;7:1257-1264.
14. Rosenberg LS, Carvlin MJ, Krugh TR. The antitumor agent mitoxantrone binds cooperatively to DNA: evidence for heterogeneity in DNA conformation. Biochemistry 1986;25:1002-1008.
15. Fidler JM, Dejoy SQ, Gibbons JR. Selective immunomodulation by the antineoplastic agent mitoxantrone. I. Suppression of B lymphocyte function. J Immunol 1986;137:727-732.
16. Fidler JM, Dejoy SQ, Smith FR. et al. Selective immunomodulation by the antineoplastic agent mitoxantrone. II. Non specific adherent suppressor cells derived from mitoxantrone-treated mice. J Immunol 1986; 136:2747-2754.
17. Levin S, Saltzman A. Regional suppression therapy after onset and prevention of relapses in experimental allergic encephalomyelitis with mitoxantrone. J Neuroimmunol 1986;13:175-181.
18. Lublin FD, Lasava M, Viti C, Knobler RL. Suppression of acute and relapsing experimental allergic encephalomyelitis with mitoxantrone. Clin Immunol Immunopathol 1987;45:122-128.
19. Gbadamosi J, Buhmann C, Tessmer W, Moench A, Haag F, Heesen C. Effects of mitoxantrone on multiple sclerosis patients' lymphocyte subpopulations and production of immunoglobulin, TNF-alpha and IL-10. Eur Neurol 2003;49:137-141.
20. Chan A, Weilbach FX, Toyka KV, Gold R. Mitoxantrone induces cell death in peripheral blood leucocytes of multiple sclerosis patients. Clin Exp Immunol 2005;139:152-158.
21. Bellosillo B, Colomer D, Pons G, Gil J. Mitoxantrone, a topoisomerase II inhibitor, induces apoptosis of B-chronic lymphocytic leukaemia cells. Br J Haematol 1998;100:142-146.
22. Neuhaus O, Wiendl H, Kieseier BC, et al. Multiple Sclerosis: immunological effects of mitoxantrone in vitro reveal antigen-presenting cells as major targets. Eur J Neurol 2002;9(suppl 2):130. Abstract.
23. Hartung HP, Gonsette R, König N, et al. Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet 2002;360:2018-2025.
24. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983;33:1444-1452.
25. Miller DH, Barkhof F, Berry I, Kappos L, Scotti G, Thompson AJ. Magnetic resonance imaging in monitoring the treatment of multiple sclerosis: concerted action guidelines. J Neurol Neurosurg Psychiatry 1991;54:683-688.
26. Miller DH. Guidelines for MRI monitoring of the treatment of multiple sclerosis: recommendations of the US Multiple Sclerosis Society's task force. Mult Scler 1996;1:335-338.
27. van Elteren PH. On the combination of independent two sample tests of Wilcoxon. Bull Int Stat Inst 1960;37:351-369.
28. Miller JL. Mitoxantrone receives multiple-sclerosis indication. Am J Health Syst Pharm 2000;57:2038-2040.
29. Steinman L. Multiple sclerosis: a two-stage disease. Nat Immunol 2001; 2:762-764.
30. Steinman L, Martin R, Bernard C, Conlon P, Oksenberg JR. Multiple sclerosis: deeper understanding of its pathogenesis reveals new targets for therapy. Annu Rev Neurosci 2002;25:491-505.
31. Confavreux C, Vukusic S, Adeleine P. Early clinical predictors and progression of irreversible disability in multiple sclerosis: an amnesic process. Brain 2003;126:770-782.
32. Barres BA, Raff MC. Proliferation of oligodendrocyte precursor cells depends on electrical activity in axons. Nature 1993;361:258-260.
33. Wilkins A, Chandran S, Compston A. A role for oligodendrocyte-derived IGF-1 in trophic support of cortical neurons. Glia 2001;36:48-57.
34. Bjartmar C, Trapp BD. Axonal degeneration and progressive neurologic disability in multiple sclerosis. Neurotox Res 2003;5:157-164.
35. Lucchinetti C, Bruck W, Parisi J, Scheithauer B, Rodriguez M, Lassmann H. Heterogeneity of multiple sclerosis lesions: implications for the pathogenesis of demyelination. Ann Neurol 2000;47:707-717.
36. Keegan M, Konig F, Bitsch A, et al. Multiple sclerosis pathological subtype predicts response to therapeutic plasma exchange. Neurology 2004;62(suppl 5):A259. Abstract.
37. Dautry C, Vaufrey F, Brouillet E, et al. Early N-acetylaspartate depletion is a marker of neuronal dysfunction in rats and primates chronically treated with the mitochondrial toxin 3-nitropropionic acid. J Cereb Blood Flow Metab 2000;20:789-799.
38. Fu L, Matthews PM, De Stefano N, et al. Imaging axonal damage of normal-appearing white matter in multiple sclerosis. Brain 1998;121: 103-113.
39. Sarchielli P, Presciutti O, Pelliccioli GP, et al. Absolute quantification of brain metabolites by proton magnetic resonance spectroscopy in normal-appearing white matter of multiple sclerosis patients. Brain 1999;122:513-521.
40. Matthews PM, Pioro E, Narayanan S, et al. Assessment of lesion pathology in multiple sclerosis using quantitative MRI morphometry and magnetic resonance spectroscopy. Brain 1996;119:715-722.
41. Miller DH, Barkhof F, Frank JA, Parker GJ, Thompson AJ. Measurement of atrophy in multiple sclerosis: pathological basis, methodological aspects and clinical relevance. Brain 2002;125:1676-1695.
42. Jones CK, Riddehough A, Li DKB, Zhao G, Paty DW, for the PRISMS Study Group and University of British Columbia MS/MRI Research Group. MRI cerebral atrophy in relapsing-remitting MS: results from the PRISMS trial. Neurology 2001;56(suppl 3):A379. Abstract.
43. Filippi M, Rovaris M, Inglese M. et al. Interferon beta-la for brain tissue loss in patients at presentation with syndromes suggestive of multiple sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet 2004;364:1489-1496.
44. Rudick RA, Fisher E, Lee JC, Simon J, Jacobs L. Use of the brain parenchymal fraction to measure whole brain atrophy in relapsing-remitting MS. Multiple Sclerosis Collaborative Research Group. Neurology 1999;53:1698-1704.
45. Gasperini C, Paolillo A, Giugni E, et al. MRI brain volume changes in relapsing-remitting multiple sclerosis patients treated with interferon beta-1a. Mult Scler 2002;8:119-123.
46. Jones CK, Riddlehough A, Li DKB, et al. MRI cerebral atrophy in relapsing-remitting MS: results from the PRISMS trial. Neurology 2001;56(suppl 3):A379. Abstract.
47. Rovaris M, Comi G, Rocca MA. Wolinsky JS, Filippi M. European/ Canadian Glatiramer Acetate Study Group. Short-term brain volume change in relapsing-remitting multiple sclerosis: effect of glatiramer acetate and implications. Brain 2001;124:1803-1812.
48. Zivadinov R, Rudick RA, De Masi R, et al. Effects of IV methylprednisolone on brain atrophy in relapsing-remitting MS. Neurology 2001; 57:1239-1247.
49. Molyneux PD, Kappos L, Polman C. et al. The effect of interferon beta-1b treatment on MRI measures of cerebral atrophy in secondary progressive multiple sclerosis. European Study Group on Interferon beta-1b in secondary progressive multiple sclerosis. Brain 2000;123: 2256-2263.
50. Rovaris M, Inglese M, van Schijndel RA, et al. Sensitivity and reproducibility of volume change measurements of different brain portions on magnetic resonance imaging in patients with multiple sclerosis. J Neurol 2000;247:960-965.
51. Paolillo A, Coles AJ, Molyneux PD, et al. Quantitative MRI in patients with secondary progressive MS treated with monoclonal antibody Campath 1H. Neurology 1999;53:751-757.
52. Sormani MP, Rovaris M, Valsasina P, Wolinsky JS, Comi G, Filippi M. Measurement error of two different techniques for brain atrophy assessment in multiple sclerosis. Neurology 2004;62:1432-1434.
53. Nesbit GM, Forbes GS, Scheithauer BW, Okazaki H, Rodriguez M. Multiple sclerosis: histopathologic and MR and/or CT correlation in 37 cases at biopsy and three cases at autopsy. Radiology 1991;180:467-474.
54. Morrissey SP, Stodal H, Zettl U, et al. In vivo MRI and its histological correlates in acute adoptive transfer experimental allergic encephalomyelitis. Quantification of inflammation and oedema. Brain 1996;119: 239-248.
55. Banati RB, Newcombe J, Gunn RN, et al. The peripheral benzodiazepine binding site in the brain in multiple sclerosis: quantitative in vivo imaging of microglia as a measure of disease activity. Brain 2000;123: 2321-2337.
56. Debruyne JC, Versijpt J, Van Laere KJ, et al. PET visualization of microglia in multiple sclerosis patients using [11C]PK11195. Eur J Neurol 2003;10:257-264.
57. Bitsch A, Schuchardt J, Bunkowski S, Kuhlmann T, Bruck W. Acute axonal injury in multiple sclerosis. Correlation with demyelination and inflammation. Brain 2000;123:1174-1183.
58. Neumann H, Schweigreiter R, Yamashita T, Rosenkranz K, Wekerle H, Barde YA. Tumor necrosis factor inhibits neurite outgrowth and branching of hippocampal neurons by a rho-dependent mechanism. J Neurosci 2002;22:854-862.
59. Redford EJ, Kapoor R, Smith KJ. Nitric oxide donors reversibly block axonal conduction: demyelinated axons are especially susceptible. Brain 1997;120:2149-2157.
60. Smith KJ, Kapoor R, Hall SM, Davies M. Electrically active axons degenerate when exposed to nitric oxide. Ann Neurol 2001;49:470-476.
61. Smith KJ, Hall SM. Factors directly affecting impulse transmission in inflammatory demyelinating disease: recent advances in our understanding. Curr Opin Neurol 2001;14:289-298.
62. Piani D, Spranger M, Frei K, Schaffner A, Fontaria A. Macrophage-induced cytotoxicity of N-methyl-D-aspartate receptor positive neurons involves excitatory amino acids rather than reactive oxygen intermediates and cytokines. Eur J Immunol 1992;22:2429-2436.
63. Piani D, Fontana A. Involvement of the cystine transport system xc- in the macrophage-induced glutamate-dependent cytotoxicity to neurons. J Immunol 1994;152:3578-3585.
64. Pitt D, Werner P, Raine CS. Glutamate excitotoxicity in a model of multiple sclerosis. Nat Med 2000;6:67-70.
65. Gveric D, Hanemaaijer R, Newcombe J, van Lent NA, Sier CF, Cuzner ML. Plasminogen activators in multiple sclerosis lesions: implications for the inflammatory response and axonal damage. Brain 2001;124: 1978-1988.
66. Paty DW, Li DK. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group II. Neurology 1993;43:662-667.
67. Nauta JJ, Thompson AJ, Barkhof F, Miller DH. Magnetic resonance imaging in monitoring the treatment of multiple sclerosis patients: statistical power of parallel-groups and crossover designs. J Neurol Sci 1994;122:6-14.
68. Simon JH, Lull J, Jacobs LD, et al. A longitudinal study of T1 hypointense lesions in relapsing MS: MSCRG trial of Interferon beta-1a. Multiple Sclerosis Collaborative Research Group. Neurology 2000;55:185-192.
69. Bech E, Lycke J, Gadeberg P, et al. A randomized, double-blind, placebo-controlled MRI study of anti-herpes virus therapy in MS. Neurology 2002;58:31-36.
70. Thompson AJ, Kermode AG, Wicks D, et al. Major differences in the dynamics of primary and secondary progressive multiple sclerosis. Ann Neurol 1991;29:53-62.