Treatment de-escalation after mitoxantrone therapy: Results of a phase IV, multicentre, open-label, randomized study of subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis

Therapeutic Advances in Neurological Disorders

Volumn 5, Issue 1, 2012, Pages 3-12

  Rieckmann, Peter ^a   Heidenreich, Fedor ^a   Sailer, Michael ^a   Zettl, Uwe K ^a   Zessack, Norbert ^a   Hartung, Hans Peter ^a   Gold, Ralf ^a  

^a Sozialstiftung Bamberg Hospital   (Germany)

Author keywords

advanced disease; de escalation therapy; mitoxantrone; relapsing multiple sclerosis; subcutaneous interferon 1a

Indexed keywords

BETA1A INTERFERON; MITOXANTRONE; NATALIZUMAB;

ADULT; ARTICLE; CHOLELITHIASIS; CHRONIC CHOLECYSTITIS; CLINICAL ARTICLE; CLOSED ANGLE GLAUCOMA; CONTROLLED STUDY; CONVULSION; DEPRESSION; DISEASE ACTIVITY; DISEASE COURSE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; EPILEPTIC STATE; EXPANDED DISABILITY STATUS SCALE; FEMALE; FLU LIKE SYNDROME; GASTROENTERITIS; GERMANY; HEMORRHOID HEMORRHAGE; HUMAN; INJECTION SITE REACTION; INTENTION TO TREAT ANALYSIS; MALE; MULTICENTER STUDY; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; UNSPECIFIED SIDE EFFECT;

EID: 84858253601     PISSN: 17562856     EISSN: 17562864     Source Type: Journal    
DOI: 10.1177/1756285611428503     Document Type: Article

References (23)

1. Berger J.R. (2010) Progressive multifocal leukoencephalopathy and newer biological agents. Drug Saf 33: 969–983.
2. Brown B.A. (2009) Natalizumab in the treatment of multiple sclerosis. Ther Clin Risk Manag 5: 585–594.
3. Cartwright M.S. Jeffery D.R. Lewis Z.T. Koty P.P. Stewart W.T. Molnar I. (2007) Mitoxantrone for multiple sclerosis causing acute lymphoblastic leukemia. Neurology 68: 1630–1631.
4. Cohen B.A. Khan O. Jeffery D.R. Bashir K. Rizvi S.A. Fox E.J. et al (2004) Identifying and treating patients with suboptimal responses. Neurology 63(12 Suppl. 6): S33-S40.
5. Edan G. Comi G. Lebrun C. Brassat D. Lubetzki C. Stankoff B. et al (2007) The French-Italian mitoxantrone-interferon-beta trial: a 3-year randomised study. Mult Scler 13(Suppl. 2): S22 (abstract 74).
6. Edan G. Miller D. Clanet M. Confavreux C. Lyon-Caen O. Lubetzki C. et al (1997) 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 62: 112–118.
7. Goodin D.S. Arnason B.G. Coyle P.K. Frohman E.M. Paty D.W. (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: 1332–1338.
8. Hartung H.P. Gonsette R. Konig N. Kwiecinski H. Guseo A. Morrissey S.P. et al (2002) Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet 360: 2018–2025.
9. Havrdova E. Galetta S. Hutchinson M. Stefoski D. Bates D. Polman C.H. et al (2009) 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: 254–260.
10. Kappos L. Traboulsee A. Constantinescu C. Eralinna J.P. Forrestal F. Jongen P. et al (2006) Long-term subcutaneous interferon beta-1a therapy in patients with relapsing–remitting MS. Neurology 67: 944–953.
11. Karussis D. Biermann L.D. Bohlega S. Boiko A. Chofflon M. Fazekas F. et al (2006) A recommended treatment algorithm in relapsing multiple sclerosis: report of an international consensus meeting. Eur J Neurol 13: 61–71.
12. Le Page E. Leray E. Edan G. (2011) Long-term safety profile of mitoxantrone in a French cohort of 802 multiple sclerosis patients: a 5-year prospective study. Mult Scler, in press.
13. Le Page E. Leray E. Taurin G. Coustans M. Chaperon J. Morrissey S.P. et al (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: 52–56.
14. Li D.K. Paty D.W., for the UBC MS / MRI Analysis Research Group and PRISMS Study Group (1999) Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing–remitting multiple sclerosis. Ann Neurol 46: 197–206.
15. Multiple Sclerosis Resource Centre (2011) 10 more PML infections, 4 more deaths in Tysabri MS patients. http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/1905 (accessed 4 May 2011).
16. National Cancer Institute (2003) Common Terminology Criteria for Adverse Events; version 3.0. http://safetyprofiler-ctep.nci.nih.gov/Utilities/WebHelp/adverse_event_reporting_resources/common_terminology_criteria_for_adverse_events_ctcae_v3.htm (accessed 28 January 2011).
17. PRISMS Study Group (1998) Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing / remitting multiple sclerosis. Lancet 352: 1498–1504.
18. PRISMS Study Group and University of British Columbia MS / MRI Analysis Group (2001) PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS. Neurology 56: 1628–1636.
19. Ramtahal J. Jacob A. Das K. Boggild M. (2006) Sequential maintenance treatment with glatiramer acetate after mitoxantrone is safe and can limit exposure to immunosuppression in very active, relapsing remitting multiple sclerosis. J Neurol 253: 1160–1164.
20. Rieckmann P. Toyka K.V. Bassetti C. Beer K. Beer S. Buettner U. et al (2004) Escalating immunotherapy of multiple sclerosis– new aspects and practical application. J Neurol 251: 1329–1339.
21. Rieckmann P. Traboulsee A. Devonshire V. Oger J. (2008) Escalating immunotherapy of multiple sclerosis. Ther Adv Neurol Disord 1: 181–192.
22. US Food and Drug Administration (2010) Mitoxantrone Hydrochloride (marketed as Novantrone and generics). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126445.htm
23. Vollmer T. Panitch H. Bar-Or A. Dunn J. Freedman M.S. Gazda S.K. et al (2008) Glatiramer acetate after induction therapy with mitoxantrone in relapsing multiple sclerosis. Mult Scler 14: 663–670.