Risk evaluation and monitoring in multiple sclerosis therapeutics

Multiple Sclerosis

Volumn 20, Issue 10, 2014, Pages 1306-1311

  Clanet, Michel C ^a   Wolinsky, Jerry S ^b   Ashton, Raymond J ^c   Hartung, Hans Peter ^d   Reingold, Stephen C ^e  

^a TOULOUSE UNIVERSITY HOSPITAL   (France)

^b UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^c AshtonMediCom   (United Kingdom)

^d HEINRICH HEINE UNIVERSITY   (Germany)

^e Scientific and Clinical Review Associates LLC   (United States)

Author keywords

Benefit; Disease modifying therapy; Multiple sclerosis; Risk; Safety; Surveillance

Indexed keywords

FINGOLIMOD; NATALIZUMAB; RITUXIMAB; IMMUNOSUPPRESSIVE AGENT;

CLINICAL DECISION MAKING; CLINICAL PRACTICE; COMORBIDITY; DOCTOR PATIENT RELATION; DRUG EXPOSURE; EVALUATION STUDY; EVIDENCE BASED MEDICINE; HUMAN; LONG TERM CARE; MULTIPLE SCLEROSIS; PATIENT ATTITUDE; PATIENT SAFETY; PHYSICIAN ATTITUDE; PRODUCT SAFETY; PROGRAM ACCEPTABILITY; PROGRAM IMPACT; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; QUALITY ADJUSTED LIFE YEAR; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SOCIAL ACCEPTANCE; TREATMENT FAILURE; ALGORITHM; ATTITUDE TO HEALTH; DECISION SUPPORT SYSTEM; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; HEALTH PERSONNEL ATTITUDE; HEALTH SURVEY; IMMUNOLOGY; INTERPERSONAL COMMUNICATION; PATIENT; PATIENT SELECTION; PERCEPTION; PREDICTIVE VALUE; PROCEDURES; PSYCHOLOGY; RISK FACTOR; TREATMENT OUTCOME;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ALGORITHMS; ATTITUDE OF HEALTH PERSONNEL; COMMUNICATION; DECISION SUPPORT TECHNIQUES; DRUG MONITORING; EVIDENCE-BASED MEDICINE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MULTIPLE SCLEROSIS; PATIENT ACCEPTANCE OF HEALTH CARE; PATIENT SELECTION; PATIENTS; PERCEPTION; PHYSICIAN-PATIENT RELATIONS; POPULATION SURVEILLANCE; PREDICTIVE VALUE OF TESTS; RISK ASSESSMENT; RISK FACTORS; TREATMENT OUTCOME;

EID: 84945286817     PISSN: 13524585     EISSN: 14770970     Source Type: Journal    
DOI: 10.1177/1352458513513207     Document Type: Review

References (28)

1. Rice GP, Incorvaia B, Munari L, et al. Interferon in relapsing-remitting multiple sclerosis. Cochrane Database Syst Rev 2001; CD002002.
2. Kieseier BC, Wiendl H, Hartung H-P, et al. Risks and benefits of multiple sclerosis therapies: Need for continual assessment? Curr Opin Neurol 2011; 24: 238-243.
3. North DW. A tutorial introduction to decision theory. IEEE Transactions on Systems Science and Cybernetics 1968; SSC-4: 200-210.
4. Lu E, Wang BW, Guimond C, et al. Disease-modifying drugs for multiple sclerosis in pregnancy. Neurology 2012; 79: 1130-1135.
5. Boster A, Bartoszek MP, O'Connell C, et al. Efficacy, safety, and cost-effectiveness of glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis. Ther Adv Neurol Disord 2011; 4: 319-332.
6. Langer-Gould A, Atlas SW, Green AJ, et al. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med 2005; 353: 375-381.
7. 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.
8. O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011; 365: 1293-1303.
9. Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012; 367: 1098-1107.
10. Stroet A, Hemmelmann C, Starck M, et al. Incidence of therapyrelated acute leukaemia in mitoxantrone-treated multiple sclerosis patients in Germany. Ther Adv Neurol Dis 2012; 5: 75-79.
11. Jeffery DR. The argument against the use of cyclophosphamide and mitoxantrone in the treatment of multiple sclerosis. J Neurol Sci 2004; 223: 41-46.
12. Confavreux C, Saddier P, Grimaud J, et al. Risk of cancer from azathioprine therapy in multiple sclerosis: A case-control study. Neurology 1996; 46: 1607-1612.
13. Coles AJ, Compston DA, Selmaj KW, et al. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med 2008; 359: 1786-1801.
14. Reingold SC. The role of data monitoring committees in multiple sclerosis clinical trials. In: Raine CS, McFarland HF, Hohlfeld R (eds) Multiple Sclerosis: A comprehensive text. Edinburgh: Elsevier Limited, 2008, pp.438-448.
15. Kachuck NJ. Registries, research, and regrets: Is the FDA's post-marketing REMS process not adequately protecting patients? Ther Adv Neurol Disord 2011; 4: 339-347.
16. Trojano M. The challenge of demonstrating long-term benefit of disease modifying therapies in multiple sclerosis. In: Cohen JA and Rudick RA (eds) Multiple sclerosis therapeutics. 4th ed. New York: Cambridge University Press, 2011, pp.244-252.
17. Sørensen PS, Bertolotto A, Edan G, et al. Risk stratification for progressive multifocal leukoencephalopathy in patients treated with natalizumab. Mult Scler 2012; 18: 143-152.
18. Polman CH, Bertolotto A, Deisenhammer F, et al. Recommendations for clinical use of data on neutralising antibodies to interferon-beta therapy in multiple sclerosis. Lancet Neurol 2010; 9: 740-750.
19. Jones JL, Phuah CL, Cox AL, et al. IL-21 drives secondary autoimmunity in patients with multiple sclerosis, following therapeutic lymphocyte depletion with alemtuzumab (Campath-1H). J Clin Invest 2009; 119: 2052-2062.
20. European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis. 20 September 2012, http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2012/10/WC500133438.pdf (accessed February-April 2013).
21. Psaty BM, Meslin EM and Breckenridge A. A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: Opportunities provided by a new IOM report, JAMA 2012; 307: 2491-2492.
22. Lee EO and Emanuel EJ. Shared decision making to improve care and reduce costs. N Engl J Med 2013; 368: 6-8.
23. 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.
24. Hofmann A, Stellmann J, Kasper J, et al. Long-term treatment risks in multiple sclerosis: Risk knowledge and risk perception in a large cohort of mitoxantrone-treated patients. Mult Scler 2013; 19: 920-925.
25. Fox R, Salter A, Alster JM, et al. Risk tolerance in MS patients: Survey results from the NARCOMS Registry. Neurology 2011; 76 (Suppl 4): A478 abstract P06.057.
26. Trepel C, Fox CR and Poldrack RA. Prospect theory on the brain? Toward a cognitive neuroscience of decision under risk. Brain Res Cogn Brain Res 2005; 23: 34-50.
27. Moore RA, Derry S, McQuay HJ, et al. What do we know about communicating risk? A brief review and suggestion for contextualising serious, but rare, risk, and the example of cox-2 selective and non-selective NSAIDs. Arthritis Res Ther 2008; 10: R20.
28. Riminton DS, Hartung HP and Reddel SW. Managing the risks of immunosuppression. Curr Opin Neurol 2011; 24: 217-223.