Efficacy and safety of BG-12 (dimethyl fumarate) and other disease-modifying therapies for the treatment of relapsing–remitting multiple sclerosis: a systematic review and mixed treatment comparison

References

• Compston A, Coles A. Multiple sclerosis. Lancet 2008;372:1502-17
   PubMed Web of Science ®Google Scholar
• Gasperini C, Ruggieri S. Development of oral agent in the treatment of multiple sclerosis: how the first available oral therapy, fingolimod will change therapeutic paradigm approach. Drug Des Devel Ther 2012;6:175-86
   PubMed Web of Science ®Google Scholar
• Scalfari A, Neuhaus A, Daumer M, et al. Onset of secondary progressive phase and long-term evolution of multiple sclerosis. J Neurol Neurosurg Psychiatry 2013;70:214-22
   Google Scholar
• National Multiple Sclerosis Society. The MS Disease – Modifying Medications. 2013. Available at: www.nationalmssociety.org [Last accessed 8 August 2011]
   Google Scholar
• Electronic Medicines Compendium. Electronic Medicines Compendium. Available at: http://emc.medicines.org.uk/ [Last accessed August 2011]
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009;151:264-9, W64
   PubMed Web of Science ®Google Scholar
• Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12
   PubMedGoogle Scholar
• NICE STA. Specification for manufacturer/sponsor submission of evidence October 2009. Available at: http://www.nice.org.uk/aboutnice/howwework/devnicetech/singletechnologyappraisalsubmissiontemplates.jsp?domedia=1&mid=4D9D8C83-19B9-E0B5-D4B0E148B3FE727F [Last accessed August 2011]
   Google Scholar
• IQWiG. Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen: General methods. Available at: https://www.iqwig.de/download/IQWiG_General_methods_V-3-0.pdf [Last accessed September 2011]
   Google Scholar
• The Cochrane collaboration. Cochrane handbook for systematic reviews of interventions. Available at: http://handbook.cochrane.org/ [Last accessed April 2013]
   Google Scholar
• Milanese C, La ML, Palumbo R, et al. A post-marketing study on interferon beta 1b and 1a treatment in relapsing-remitting multiple sclerosis: different response in drop-outs and treated patients. J Neurol Neurosurg Psychiatry 2003;74:1689-92
   PubMed Web of Science ®Google Scholar
• Limmroth V, Putzki N, Kachuck NJ. The interferon beta therapies for treatment of relapsing-remitting multiple sclerosis: are they equally efficacious? A comparative review of open-label studies evaluating the efficacy, safety, or dosing of different interferon beta formulations alone or in combination. Ther Adv Neurol Disord 2011;4:281-96
   PubMedGoogle Scholar
• Fleurence RL, Hollenbeak CS. Rates and probabilities in economic modelling: transformation, translation and appropriate application. Pharmacoeconomics 2007;25:3-6
   PubMed Web of Science ®Google Scholar
• 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;367:1098-107
   PubMed Web of Science ®Google Scholar
• Knobler RL, Greenstein JI, Johnson KP, et al. Systemic recombinant human interferon-(beta) treatment of relapsing-remitting multiple sclerosis: pilot study analysis and six-year follow-up. J Interferon Res 1993;13:333-40
   PubMedGoogle Scholar
• O'Connor P, Filippi M, Arnason B, et al. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol 2009;8:889-97
   PubMed Web of Science ®Google Scholar
• Wroe SJ. Effects of dose titration on tolerability and efficacy of interferon beta-1b in people with multiple sclerosis. J Int Med Res 2005;33:309-18
   PubMed Web of Science ®Google Scholar
• Sibley WA, Duquette P, Knobler RL, et al. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology 1995;45:1277-85
   PubMed Web of Science ®Google Scholar
• Calabrese M, Bernardi V, Atzori M, et al. Effect of disease-modifying drugs on cortical lesions and atrophy in relapsing–remitting multiple sclerosis. Multiple Sclerosis 2011;18:418-424
   PubMed Web of Science ®Google Scholar
• Etemadifar M, Janghorbani M, Shaygannejad V. Comparison of Betaferon, Avonex, and Rebif in treatment of relapsing–remitting multiple sclerosis. Acta Neurol Scand 2006;113:283-7
   PubMed Web of Science ®Google Scholar
• Bornstein MB, Miller A, Slagle S. A pilot trial of cop 1 in exacerbating–remitting multiple sclerosis. N Engl J Med 1987;317:408-14
   PubMed Web of Science ®Google Scholar
• Kappos L, Calabresi P, Connor P, et al. Efficacy and safety of ocrelizumab in patients with relapsing–remitting multiple sclerosis: results of a phase II randomised placebo-controlled multicentre trial. Multiple Sclerosis 2010;16:S33-4
   Google Scholar
• Cadavid D, Wolansky LJ, Skurnick J, et al. Efficacy of treatment of MS with IFN(beta)2-1b or glatiramer acetate by monthly brain MRI in the BECOME study. Neurology 2009;72:1976-83
   PubMed Web of Science ®Google Scholar
• Calabresi PA, Goodin D, Jeffery D, et al. Efficacy and safety of fingolimod versus placebo: primary outcomes from the phase 3 FREEDOMS II study in patients with relapsing remitting multiple sclerosis. 28th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS). 10--13 October 2012. Lyon, France, P491
   Google Scholar
• Polman CH, 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
   PubMed Web of Science ®Google Scholar
• Kappos L, Radue EW, Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387-401
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Vollmer TL, Soelberg Sorensen P, Arnold DL. A placebo-controlled and active comparator phase III trial (BRAVO) for relapsing–remitting multiple sclerosis. 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis. 19--22 October 2011. Amsterdam, The Netherlands, Abstract No. 148
   Google Scholar
• De Stefano N, Curtin F, Stubinski B, et al. Rapid benefits of a new formulation of subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis. Multiple Sclerosis 2010;16:888-92
   PubMed Web of Science ®Google Scholar
• Killestein J, Rudick RA, Polman CH. Oral treatment for multiple sclerosis. Lancet Neurol 2011;10:1026-34
   PubMed Web of Science ®Google Scholar
• Jeffery DR. Recent advances in treating multiple sclerosis: efficacy, risks and place in therapy. Ther Adv Chronic Dis 2013;4:45-51
   Google Scholar
• Phillips JT, Fox RJ, Selmaj K, et al. Safety profile of BG-12 (dimethyl fumarate) in relapsing–remitting multiple sclerosis: long-term interim results from the ENDORSE extension study. 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, 2--5 October 2013. Copenhagen, Denmark
   Google Scholar
• Disanto G, Berlanga AJ, Handel AE, et al. Heterogeneity in multiple sclerosis: scratching the surface of a complex disease. Autoimmune Dis 2010;2011:932351
   PubMedGoogle Scholar
• Fox R, Miller D, Phillips JT, et al. Clinical efficacy of BG-12 in relapsing–remitting multiple sclerosis (RRMS): data from the phase 3 CONFIRM study. The American Academy of Neurology's 64th AAN Annual Meeting. 21--28 April 2012. New Orleans, LA, SO1.003
   Google Scholar
• Ebers GC, Rice G, Lesaux J, et al. Randomised double-blind placebo-controlled study of interferon (beta)-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498-504
   PubMed Web of Science ®Google Scholar
• Schwid SR, Panitch HS. Full results of the Evidence of Interferon Dose-Response–European North American Comparative Efficacy (EVIDENCE) study: a multicenter, randomized, assessor-blinded comparison of low-dose weekly versus high-dose, high-frequency interferon (beta)-1a for relapsing multiple sclerosis. Clin Therapeut 2007;29:2031-48
   PubMed Web of Science ®Google Scholar
• 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;7:903-14
   PubMed Web of Science ®Google Scholar
• 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. Neurology 1995;45:1268-76
   PubMed Web of Science ®Google Scholar
• Comi G, Filippi M, Wolinsky JS. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol 2001;49:290-7
   PubMed Web of Science ®Google Scholar
• Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39:285-94
   PubMed Web of Science ®Google Scholar
• Durelli L, Verdun E, Barbero P, et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002;359:1453-60
   PubMed Web of Science ®Google Scholar
• Saida T, Kikuchi S, Itoyama Y, et al. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Multiple Sclerosis 2012;18:1269-77
   PubMed Web of Science ®Google Scholar
• O'Connor P, Li D, Freedman MS, et al. A phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology 2006;66:894-900
   PubMed Web of Science ®Google Scholar