Emerging oral drugs for relapsing–remitting multiple sclerosis

Bibliography

• Weinshenker BG. The natural history of multiple sclerosis. Neurol Clin 1995;16:119-46
   Google Scholar
• Murray TJ. Diagnosis and treatment of multiple sclerosis. BMJ 2006;332:525-7
   PubMed Web of Science ®Google Scholar
• Compston A, Coles A. Multiple sclerosis. Lancet 2008;372:1502-17
   PubMed Web of Science ®Google Scholar
• Scalfari A, Neuhaus A, Degenhardt A, The natural history of multiple sclerosis: a geographically based study 10: relapses and long-term disability. Brain 2010;133(Pt 7):1914-12
   PubMed Web of Science ®Google Scholar
• Hu W, Lucchinetti CF. The pathological spectrum of CNS inflammatory demyelinating diseases. Semin Immunopathol 2009;31:439-53
   PubMed Web of Science ®Google Scholar
• Galetta SL, Markowitz C. US FDA-approved disease-modifying treatments for multiple sclerosis: review of adverse effect profiles. CNS Drugs 2005;19:239-52
   PubMed Web of Science ®Google Scholar
• Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226755.htm
   Google Scholar
• Australian Therapeutic Goods Administration. Australian public assessment report for cladribine tablets [online]. Available from: http://www.tga.gov.au/pdf/auspar/auspar-movectro.pdf [Accessed 20 June 2011]
   Google Scholar
• Carson DA, Wasson DB, Taetle R, Specific toxicity of 2-chlorodeoxyadenosine toward resting and proliferating human lymphocytes. Blood 1983;62:737-43
   PubMed Web of Science ®Google Scholar
• Beutler E. New chemotherapeutic agent: 2-chlorodeoxyadenosine. Semin Hematol 1994;31(1):40-5
   PubMed Web of Science ®Google Scholar
• Schirmer M, Mur E, Pfeiffer KP, The safety profile of low-dose cladribine in refractory rheumatoid arthritis. A pilot trial. Scand J Rheumatol 1997;26:376-9
   PubMed Web of Science ®Google Scholar
• Beutler E, Sipe JC, Romine JS, The treatment of chronic progressive multiple sclerosis with cladribine. Proc Natl Acad Sci USA 1996;93:1716-20
   PubMed Web of Science ®Google Scholar
• Rice GP, Filippi M, Comi G. Cladribine and progressive MS: clinical and MRI outcomes of a multicenter controlled trial. Cladribine MRI Study Group. Neurology 2000;54:1145-55
   PubMed Web of Science ®Google Scholar
• Kopadze T, Dobert M, Leussink VI, Cladribine impedes in vitro migration of mononuclear cells: a possible implication for treating multiple sclerosis. Eur J Neurol 2009;16:409-12
   PubMed Web of Science ®Google Scholar
• Liliemark J. The clinical pharmacokinetics of cladribine. Clin Pharmacokinet 1997;32:120-31
   PubMed Web of Science ®Google Scholar
• Van Axel Castelli V, Trivieri G, Zucchelli I, Characterisation of an inclusion complex between cladribine and 2-hydroxypropyl-beta-cyclodextrin. J Pharm Sci 2008;97(9):3897-906
   PubMed Web of Science ®Google Scholar
• Muir VJ, Plosker GL. Cladribine tablets: in relapsing-remitting multiple sclerosis. CNS Drugs 2011;25:239-4
   PubMed Web of Science ®Google Scholar
• Giovannoni G, Comi G, Cook S, CLARITY Study Group. A placebo controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med 2010;362:416-26
   PubMed Web of Science ®Google Scholar
• Stelmasiak Z, Solski J, Nowicki J, Effect of parenteral cladribine on relapse rates in patients with relapsing forms of multiple sclerosis: results of a 2-year, double-blind, placebo-controlled, crossover study. Mult Scler 2009;15:767-70
   PubMed Web of Science ®Google Scholar
• Cook S, Vermersch P, Comi G, Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study. Mult Scler 2011;17:578-93
   PubMed Web of Science ®Google Scholar
• Rieckmann P, Giovannoni G, Cook SD, Cladribine tablets in relapsing-remitting multiple sclerosis: study design of the 2-year, Phase IIIb CLARITY (CLAdRibine tablets Treating multiple sclerosis orallY) extension study. Mult Scler 2008;14:S161-2
   Web of Science ®Google Scholar
• Salvadori M, Budde K, Charpentier B, FTY720 versus MMF with cyclosporine in de novo renal transplantation: a 1-year, randomized controlled trial in Europe and Australasia. Am J Transplant 2006;6:2912-21
   PubMed Web of Science ®Google Scholar
• Fujino M, Funeshima N, Kitazawa Y, Amelioration of experimental autoimmune encephalomyelitis in Lewis rats by FTY720 treatment. J Pharmacol Exp Ther 2003;305:70-7
   PubMed Web of Science ®Google Scholar
• Chun J, Hartung HP. Mechanism of action of oral Fingolimod (FTY720) in multiple sclerosis. Clin Neuropharmacol 2010;33:91-10
   PubMed Web of Science ®Google Scholar
• Takabe K, Paugh SW, Milstien S, “Inside-out” signaling of sphingosine-1-phosphate: therapeutic targets. Pharmacol Rev 2008;60:181-95
   PubMed Web of Science ®Google Scholar
• Dev KK, Mullershausen F, Mattes H, Brain sphingosine-1-phosphate receptors: implication for FTY720 in the treatment of multiple sclerosis. Pharmacol Ther 2008;117:77-93
   PubMed Web of Science ®Google Scholar
• Mehling M, Johnson TA, Antel J, Clinical immunology of the sphingosine 1-phosphate receptor modulator fingolimod (FTY720) in multiple sclerosis. Neurology 2011;76:S20-7
   PubMed Web of Science ®Google Scholar
• Ishii I, Fukushima N, Ye X, Lysophospholipid receptors: signaling and biology. Annu Rev Biochem 2004;73:321-54
   PubMed Web of Science ®Google Scholar
• Kovarik JM, Schmouder R, Barilla D, Multiple-dose FTY720: tolerability, pharmacokinetics, and lymphocyte responses in healthy subjects. J Clin Pharmacol 2004;44:532-7
   PubMed Web of Science ®Google Scholar
• Kappos L, Antel J, Comi G, Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med 2006;355(11):1124-40
   PubMed Web of Science ®Google Scholar
• O'Connor P, Comi G, Montalban X, Oral fingolimod (FTY720) in multiple sclerosis: two-year results of a phase II extension study. Neurology 2009;72:73-9
   PubMed Web of Science ®Google Scholar
• Comi G, O'Connor P, Montalban X, for the FTY720D2201 Study Group. Phase II study of oral fingolimod (FTY720) in multiple sclerosis: 3-year results. Mult Scler 2010;16:197-207
   PubMed Web of Science ®Google Scholar
• Cohen JA, Barkhof F, Comi G, Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362:402-15
   PubMed Web of Science ®Google Scholar
• Kappos L, Radue EW, O'Connor P, 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
• Leypoldt F, Munchau A, Moeller F, Hemorrhaging focal encephalitis under fingolimod (FTY720) treatment: a case report. Neurology 2009;72:1022-4
   PubMed Web of Science ®Google Scholar
• Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_ _Conditions_imposed_on_member_states_for_safe_and_effective_use/human/002202/WC500104527.pdf
   Google Scholar
• Kasper LH, Due BR, ONO-4641 Study Group. A phase I study to evaluate safety, tolerability and pharmacological properties of a selective sphingosine-1-phosphate (S1P) receptor agonist ONO-4641 in patients with multiple sclerosis [poster no. P991]. 26th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis; 13 – 16 October 2010; Gothenburg
   Google Scholar
• Herrmann ML, Schleyerbach R, Kirschbaum BJ. Leflunomide: an immunomodulatory drug for the treatment of rheumatoid arthritis and other autoimmune diseases. Immunopharmacology 2000;47:273-89
   PubMed Web of Science ®Google Scholar
• Claussen MC, Korn T. Immune mechanisms of new therapeutic strategies in MS — Teriflunomide. Clin Immunol 2011 Feb 28. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Merrill JE, Hanak S, Pu SF, Teriflunomide reduces behavioral, electrophysiological, and histopathological deficits in the Dark Agouti rat model of experimental autoimmune encephalomyelitis. J Neurol 2009;256:89-103
   PubMed Web of Science ®Google Scholar
• Bruneau JM, Yea CM, Spinella-Jaegle S, Purification of human dihydro-orotate dehydrogenase and its inhibition by A77 1726, the active metabolite of leflunomide. Biochem J 1998;336:299-303
   PubMed Web of Science ®Google Scholar
• O'Connor PW, Li D, Freedmann MS, 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
• O'Connor P, Li D, Freedman M, on behalf of the Teriflunomide Multiple Sclerosis Trial Group. Oral teriflunomide is effective and well tolerated in multiple sclerosis with relapses: results of an open-label 144-week extension study [Poster 379]. Program and abstracts of the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis; 28 September 2006; Madrid, Spain
   Google Scholar
• O'Connor P, Wolinsky J, Confavreux C, A placebo controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis: clinical efficacy and safety outcomes [abstract]. Mult Scler 2010;16:S23- 79
   Google Scholar
• Freedman M, Wolinsky JS, Byrnes WJ, Oral teriflunomide or placebo added to interferon beta for 6 months in patients with relapsing multiple sclerosis: safety and efficacy results [abstract P878]. Presented at: 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); 9 – 12 September 2009; Dυsseldorf, Germany. Mult Scler 2009;15(9):S273
   Google Scholar
• Freedman M, Wolinsky JS, Frangin GA, Oral teriflunomide or placebo added to glatiramer acetate for 6 months in patients with relapsing multiple sclerosis: Safety and efficacy results [abstract S21.001]. Presented at: 62nd Annual Meeting of the American Academy of Neurology (AAN); 10 – 17 April 2010; Toronto, Ont., Canada. Neurology 2010;74(9 Suppl 2):A293
   Google Scholar
• Available from: http://clinicaltrials.gov/
   Google Scholar
• Brunmark C, Runstrom A, Ohlsson L, The new orally active immunoregulator laquinimod (ABR-215062) effectively inhibits development and relapses of experimental autoimmune encephalomyelitis. J Neuroimmunol 2002;130:163-72
   PubMed Web of Science ®Google Scholar
• Gurevich M, Gritzman T, Orbach R, Laquinimod suppress antigen presentation in relapsing-remitting multiple sclerosis: in-vitro high-throughput gene expression study. J Neuroimmunol 2010;221:87-94
   PubMed Web of Science ®Google Scholar
• Wegner C, Stadelmann C, Pfortner R, Laquinimod interferes with migratory capacity of T cells and reduces IL-17 levels, inflammatory demyelination and acute axonal damage in mice with experimental autoimmune encephalomyelitis. J Neuroimmunol 2010;227:133-4
   PubMed Web of Science ®Google Scholar
• Polman C, Barkhof F, Sandberg-Wollheim M, Treatment with laquinimod reduces development of active MRI lesions in relapsing MS. Neurology 2005;64:987-91
   PubMed Web of Science ®Google Scholar
• Comi G, Pulizzi A, Rovaris M, Effect of laquinimod on MRI-monitored disease activity in patients with relapsing remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet 2008;371:2085-92
   PubMed Web of Science ®Google Scholar
• Comi G, Abramsky O, Arbizu T, Oral laquinimod in patients with relapsing–remitting multiple sclerosis: 36-week double-blind active extension of the multicentre, randomized, double-blind, parallel-group placebo controlled study. Mult Scler 2010;16:1360-6
   PubMed Web of Science ®Google Scholar
• Comi G, Jeffrey D, Kappos L, Oral laquinimod reduced relapse rate and delayed progression of disability in ALLEGRO, a placebo-controlled phase III trial for relapsing-remitting multiple sclerosis [abstract #P05.288]. Presented at: American Academy of Neurology (AAN) 63rd Annual Meeting; 9 – 16 April 2011
   Google Scholar
• Vollmer TL, Soelberg Sorensen P. Arnold DL on behalf of the BRAVO study. A placebo-controlled and active comparator phase III trial (BRAVO) for relapsing-remitting multiple sclerosis. (abstract). Mult Scler 2011;17:S507-24
   Web of Science ®Google Scholar
• Schweckendiek W. Treatment of psoriasis vulgaris. Med Monatsschr 1959;13:103-4
   PubMedGoogle Scholar
• Mrowietz U, Rostami-Yazdi M, Neureither M, 15 years of fumaderm: fumaric acid esters for the systemic treatment of moderately severe and severe psoriasis vulgaris. J Dtsch Dermatol Ges 2009;7(Suppl 2):S3-16
   PubMed Web of Science ®Google Scholar
• Linker RA, Lee DH, Ryan S, Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway. Brain 2011;134:678-92
   PubMed Web of Science ®Google Scholar
• Vandermeeren M, Janssens S, Borgers M, Dimethylfumarate is an inhibitor of cytokine-induced E-selectin, VCAM-1, and ICAM-1 expression in human endothelial cells. Biochem Biophys Res Commun 1997;234:19-23
   PubMed Web of Science ®Google Scholar
• Treumer F, Zhu K, Glaser R, Dimethylfumarate is a potent inducer of apoptosis in human T cells. J Invest Dermatol 2003;121:1383-8
   PubMed Web of Science ®Google Scholar
• Loewe R, Pillinger M, De Martin R, Dimethyl fumarate inhibits tumor-necrosis factor-induced CD62E expression in an NF-kappa B-dependent manner. J Invest Dermatol 2001;117:1363-8
   PubMed Web of Science ®Google Scholar
• Litjens NH, Rademaker M, Ravensbergen B, Monomethylfumarate affects polarization of monocyte-derived dendritic cells resulting in down-regulated Th1 lymphocyte responses. Eur J Immunol 2004;34:565-75
   PubMed Web of Science ®Google Scholar
• Schilling S, Goelz S, Linker R, Fumaric acid esters are effective in chronic experimental autoimmune encephalomyelitis and suppress macrophage infiltration. Clin Exp Immunol 2006;145:101-7
   PubMed Web of Science ®Google Scholar
• Schimrigk S, Brune N, Hellwig K, Oral fumaric acid esters for the treatment of active multiple sclerosis: an open-label, baseline-controlled pilot study. Eur J Neurol 2006;13:604-10
   PubMed Web of Science ®Google Scholar
• Kappos L, Gold R, Miller DH, 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
   PubMed Web of Science ®Google Scholar
• MacManus DG, Miller DH, Kappos L, BG-12 reduces evolution of new enhancing lesions to T1-hypointense lesions in patients with multiple sclerosis. J Neurol 2011;258:449-5
   PubMed Web of Science ®Google Scholar
• Hoefnagel JJ, Thio HB, Willemze R, Long-term safety aspects of systemic therapy with fumaric acid esters in severe psoriasis. Br J Dermatol 2003;149:363-9
   PubMed Web of Science ®Google Scholar