Risks and benefits of multiple sclerosis therapies: Need for continual assessment?

Current Opinion in Neurology

Volumn 24, Issue 3, 2011, Pages 238-243

  Kieseier, Bernd C ^a   Wiendl, Heinz ^b   Hartung, Hans Peter ^a   Leussink, Verena Isabell ^a   Stüve, Olaf ^c,d  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b UNIVERSITY OF MÜNSTER   (Germany)

^c VA NORTH TEXAS HEALTH CARE SYSTEM   (United States)

^d UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

benefit; immunotherapy; multiple sclerosis; risk; treatment choices

Indexed keywords

BETA INTERFERON; BETA1A INTERFERON; CLADRIBINE; FINGOLIMOD; GLATIRAMER; NATALIZUMAB;

DRUG EFFICACY; DRUG SAFETY; HUMAN; MEDICAL DECISION MAKING; MULTIPLE SCLEROSIS; NONHUMAN; PHYSICIAN; RECURRENT DISEASE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; TREATMENT RESPONSE;

CLINICAL TRIALS AS TOPIC; HUMANS; MULTIPLE SCLEROSIS; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 79955573527     PISSN: 13507540     EISSN: 14736551     Source Type: Journal    
DOI: 10.1097/WCO.0b013e32834696dd     Document Type: Review

References (38)

1. Kieseier BC, Stü ve O. A critical appraisal of treatment decisions in multiple sclerosis: old versus new. Nat Rev Neurol (in press).
2. Rothwell PM, McDowell Z, Wong CK, Dorman PJ. Doctors and patients don't agree: cross sectional study of patients' and doctors' perceptions and assessments of disability in multiple sclerosis. Br Med J 1997; 314:1580-1583. (Pubitemid 27229105)
3. Nortvedt MW, Riise T, Myhr KM, Nyland HI. Quality of life in multiple sclerosis: measuring the disease effects more broadly. Neurology 1999; 53:1098-1103. (Pubitemid 29442130)
4. Forbes A, While A, Mathes L, Griffiths P. Health problems and health-related quality of life in people with multiple sclerosis. Clin Rehabil 2006; 20:67-78. (Pubitemid 43246334)
5. Miller DM, Allen R. Quality of life in multiple sclerosis: determinants, measurement, and use in clinical practice. Curr Neurol Neurosci Rep 2010; 10:397-406.
6. Fisk JD, Pontefract A, Ritvo PG, et al. The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci 1994; 21:9-14. (Pubitemid 24090744)
7. Fruehwald S, Loeffler-Stastka H, Eher R, et al. Depression and quality of life in multiple sclerosis. Acta Neurol Scand 2001; 104:257-261. (Pubitemid 32977143)
8. Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol 2008; 7:1139-1151.
9. Rudick RA, Miller DM. Health-related quality of life in multiple sclerosis: current evidence, measurement and effects of disease severity and treatment. CNS Drugs 2008; 22:827-839.
10. Spain LA, Tubridy N, Kilpatrick TJ, et al. Illness perception and health-related quality of life in multiple sclerosis. Acta Neurol Scand 2007; 116:293-299. (Pubitemid 47537415)
11. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann Neurol 1996; 39:285-294. (Pubitemid 26100751)
12. 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 1995; 45:1268-1276.
13. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352:1498-1504.
14. The IFNB Multiple Sclerosis Study Group, the University of British Columbia MS/MRI Analysis Group. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology 1995; 45:1277-1285.
15. Havrdova 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 2009; 8:254-260.
16. Coles AJ, Fox E, Vladic A, et al. Alemtuzumab versus interferon beta-1a in early relapsing-remitting multiple sclerosis: post-hoc and subset analyses of clinical efficacy outcomes. Lancet Neurol 2011; 10:338-348.
17. Polman CH, O'Connor PW, Havrdova E, et al. A randomized, placebocontrolled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006; 354:899-910.
18. Giovannoni G, Comi G, Cook S, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med 2010; 362:416-426.
19. Kappos L, Radue EW, O'Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010; 362:387-401.
20. Klawiter EC, Cross AH, Naismith RT. The present efficacy of multiple sclerosis therapeutics: is the new 66% just the old 33%? Neurology 2009; 73:984-990.
21. Inusah S, Sormani MP, Cofield SS, et al. Assessing changes in relapse rates in multiple sclerosis. Mult Scler 2010; 16:1414-1421.
22. Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE trial. Neurology 2002; 59:1496-1506. (Pubitemid 35387053)
23. Mikol DD, Barkhof F, Chang P, et al. Comparison of subcutaneous interferon beta-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 2008; 7:903-914.
24. Koch-Henriksen N, Sorensen PS. The changing demographic pattern of multiple sclerosis epidemiology. Lancet Neurol 2010; 9:520-532.
25. O'Connor P, Filippi M, Arnason B, et al. mug or 500 mug interferon beta-1b versus 20mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol 2009; 8:889-897.
26. Cohen JA, Barkhof F, Comi G, et al.Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010; 362:402-415.
27. Marriott JJ, Miyasaki JM, Gronseth G, O'Connor PW. Evidence report: the efficacy and safety of mitoxantrone (Novantrone) in the treatment of multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2010; 74:1463-1470.
28. Clifford DB, De Luca A, Simpson DM, et al. Natalizumab-associated progressive multifocal leukoencephalopathy in patients with multiple sclerosis: lessons from 28 cases. Lancet Neurol 2010; 9:438-446.
29. Suntharalingam G, PerryMR, Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006; 355:1018-1028. (Pubitemid 44343545)
30. Heesen C, Kleiter I, Nguyen F, et al. Risk perception in natalizumab-treated multiple sclerosis patients and their neurologists. Mult Scler 2010; 16:1507-1512.
31. Ghalie RG, Edan G, Laurent M, et al. Cardiac adverse effects associated with mitoxantrone (Novantrone) therapy in patients with MS. Neurology 2002; 59:909-913.
32. Ellis R, Boggild M. Therapy-related acute leukaemia with mitoxantrone: what is the risk and can we minimise it? Mult Scler 2009; 15:505-508.
33. Ramtahal J, Jacob A, Das K, Boggild M. 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 2006; 253:1160-1164. (Pubitemid 44511472)
34. Vollmer T, Panitch H, Bar-Or A, et al. Glatiramer acetate after induction therapy with mitoxantrone in relapsing multiple sclerosis. Mult Scler 2008; 14:663-670. (Pubitemid 351954409)
35. Le Page E, Leray E, Taurin G, et al. 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 2008; 79:52-56.
36. Stuve O, Cravens PD, Frohman EM, et al. Immunologic, clinical, and radiologic status 14 months after cessation of natalizumab therapy. Neurology 2009; 72:396-401.
37. Vellinga MM, Castelijns JA, Barkhof F, et al. Postwithdrawal rebound increase in T2 lesional activity in natalizumab-treated MS patients. Neurology 2008; 70:1150-1151. (Pubitemid 351464749)
38. Killestein J, Vennegoor A, Strijbis EM, et al. Natalizumab drug holiday in multiple sclerosis: poorly tolerated. Ann Neurol 2010; 68:392-395.