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Key Paper Evaluation

Oral BG-12 (dimethyl fumarate) for relapsing–remitting multiple sclerosis: a review of DEFINE and CONFIRM

Evaluation of: Gold R, Kappos L, Arnold D, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098-107; and Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97

, MD PhD, , MD, , PhD, , MS, , MD PhD, , MD & , MD show all
Pages 2145-2156 | Published online: 24 Aug 2013

Bibliography

  • Zwibel HL, Smrtka J. Improving quality of life in multiple sclerosis: an unmet need. Am J Manag Care 2011;17:S139-45
  • Hauser SL, Goodwin DS. Multiple sclerosis and other demyelinating diseases. In: Fauci AS, Braunwald E, Kasper DL, Hauser SL, editors. Harrison's principles of internal medicine. 17th edition. II McGraw-Hill Medical; New York: 2008. p. 2611-21
  • Amato MP. Pharmacoeconomic considerations of multiple sclerosis therapy with the new disease-modifying agents. Expert Opin Pharmacother 2004;5:2115-26
  • Blahova DJ, Kalincik T, Dolezal T, et al. Cost of multiple sclerosis in the Czech Republic: the COMS study. Mult Scler 2012;18:662-8
  • O'Brien JA, Ward AJ, Patrick AR, et al. Cost of managing an episode of relapse in multiple sclerosis in the United States. BMC Health Service Research 2003;3:17
  • Kappos L, Freedman MS, Polman CH, et al. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol 2009;8:987-97
  • Lazzaro C, Bianchi C, Peracino L, et al. Economic evaluation of treating clinically isolated syndrome and subsequent multiple sclerosis with interferon beta-1b. Neurol Sci 2009;30:21-31
  • Curkendall SM, Wang C, Johnson BH, et al. Potential health care cost savings associated with early treatment of multiple sclerosis using disease-modifying therapy. Clin Ther 2011;33:914-25
  • Linker RA, Lee DH, Ryan S, et al. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway. Brain 2011;134:678-92
  • Scannevin RH, Chollate S, Jung MY, et al. Fumarates promote cytoprotection of central nervous system cells against oxidative stress via the Nrf2 pathway. J Pharmacol Exp Ther 2012;341:274-84
  • 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 2008;372:1463-72
  • Gold R, Kappos L, Arnold D, et al. Placebo-controlled Phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098-107
  • Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97
  • Polman CH, Reingold SC, Edan G, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann Neurol 2005;58:840-6
  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983;33:1444-52
  • Kappos L, Gold R, Arnold D, et al. BG-12 effects on patient-reported outcomes in relapsing-remitting multiple sclerosis: results from the DEFINE study. Mult Scler 2011;17:S488; P1071
  • Kita M, Fox RJ, Phillips JT, et al. Effects of BG-12 on quality of life in patients with relapsing–remitting multiple sclerosis: findings from the CONFIRM study. Mult Scler 2012;18:254 (P586)
  • Ware JE Jr. SF-36 health survey update. Spine 2000;25:3130-9
  • Arnold DL, Gold R, Kappos L, et al. Effects of BG-12 on magnetic resonance imaging outcomes in the DEFINE study. Int J MS Care 2012;14:46; DX21
  • Rudick RA, Miller D, Hass S, et al. Health-related quality of life in multiple sclerosis: effects of natalizumab. Ann Neurol 2007;62:335-46
  • Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582-92
  • Temple R. Hy's law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf 2006;15:241-3
  • Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362:402-15
  • IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993;43:655-61
  • 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;39:285-94
  • 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;45:1268-76
  • 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
  • Polman CH, O'Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006;354:899-910
  • PRISMS Study Group. Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. European Study Group on interferon beta-1b in secondary progressive MS. Lancet 1998;352:1491-7
  • Ghoreschi K, Bruck J, Kellerer C, et al. Fumarates improve psoriasis and multiple sclerosis by inducing type II dendritic cells. J Exp Med 2011;208:2291-303
  • Kappos L, Gold R, Miller DH, et al. Effect of BG-12 on contrast-enhancing lesions in patients with relapsing-remitting multiple sclerosis: subgroup analyses from the phase 2b study. Mult Scler 2012;18:314-21
  • Comi G, Jeffery D, Kappos L, et al. Placebo-controlled trial of oral laquinimod for multiple sclerosis. N Engl J Med 2012;366:1000-9
  • O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011;365:1293-303
  • Devonshire V, Lapierre Y, Macdonell R, et al. The Global Adherence Project (GAP): a multicenter observational study on adherence to disease-modifying therapies in patients with relapsing-remitting multiple sclerosis. Eur J Neurol 2011;18:69-77
  • Steinberg SC, Faris RJ, Chang CF, et al. Impact of adherence to interferons in the treatment of multiple sclerosis: a non-experimental, retrospective, cohort study. Clin Drug Investig 2010;30:89-100
  • Tan H, Cai Q, Agarwal S, et al. Impact of adherence to disease-modifying therapies on clinical and economic outcomes among patients with multiple sclerosis. Adv Ther 2011;28:51-61
  • Phillips JT, Fox R, Selmaj K, et al. Safety and tolerability of oral BG-12 (dimethyl fumarate) in relapsing-remitting multiple sclerosis (RRMS): interim results from ENDORSE Extension Study [Poster P01.162]. Annual Meeting of the American Academy of Neurology; 16–23 March 2013; San Diego, CA
  • US Food and Drug Administration. TECFIDERATM. Prescribing Information. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf
  • Mohr DC, Boudewyn AC, Likosky W, et al. Injectable medication for the treatment of multiple sclerosis: the influence of self-efficacy expectations and injection anxiety on adherence and ability to self-inject. Ann Behav Med 2001;23:125-32
  • Beer K, Muller M, Hew-Winzeler AM, et al. The prevalence of injection-site reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study. BMC Neurol 2011;11:144
  • Calabresi PA, Gooding D, Jeffrey D. Efficacy and safety of fingolimod versus placebo: Primary outcomes from the phase 3 FREEDOMS II study in patients with relapsing-remitting multiple slcerosis [Poster P491]. European Committee for Treatment and Research in Multiple Sclerosis; 10–13 October 2012; Lyon, France
  • Novartis Pharmaceuticals Corporation. Gilenya®. Prescribing Information. Available from: www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf
  • European Medicines Agency (EMA). European Medicines Agency starts review of Gilenya (fingolimod). Doctors advised to intensify cardiovascular monitoring after first dose. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/01/news_detail_001425.jsp&mid=WC0b01ac058004d5c1&jsenabled=true
  • FDA. Gilenya (fingolimod): drug Safety Communication - Safety Review of a Reported Death After the First Dose. Available from: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284355.htm
  • Vermersch P, Czlonkowska A, Grimaldi LM, et al. A multicenter, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis. Mult Scler 2012;18:S9-S10
  • Sanofi-Aventis. Arava (leflunomide) package insert. Available from: http://products.sanofi.us/arava/arava.html
  • Vollmer TL, Soelberg Sørensen P, Arnold DL, et al. A placebo-controlled and active comparator phase III trial (BRAVO) for relapsing-remitting multiple sclerosis. Mult Scler 2011;17:S507 (148)
  • Confavreux C, Moreau T. Emerging treatments in multiple sclerosis: azathioprine and mofetil. Mult Scler 1996;1:379-84
  • Selmaj K, Gold R, Kappos L, et al. Safety and tolerability of BG-12 in the phase 3 DEFINE trial in patients with relapsing-remitting multiple sclerosis [Poster 994]. Annual Congress of European Committee for Treatment and Research in Multiple Sclerosis; 19–22 October 2011; Amsterdam, Netherlands
  • Havrdova E, Phillips JT, Fox RJ, et al. Safety and tolerability of BG-12 in patients with relapsing-remitting multiple sclerosis: results from the phase 3 CONFIRM (Comparator and an oral Fumarate In Relapsing–remitting Multiple sclerosis) study [Poster P457]. 22nd Meeting of the European Neurological Society; 9–12 June 2012; Prague, Czech Republic
  • Biogen Idec Inc. Data on file 2012

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