610
Views
38
CrossRef citations to date
0
Altmetric
Drug Evaluations

The use of ustekinumab in autoimmune disease

, MB BCh BAO (Hons) BMedSc (Hons), , MD, , BSc (Hons) MBChB (Hons) PhD & , MD
Pages 587-604 | Published online: 11 Mar 2010

Bibliography

  • Trinchieri G. Interleukin-12 and the regulation of innate resistance and adaptive immunity. Nat Rev Immunol 2003;3:133-46
  • Oppmann B, Lesley R, Blom B, Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12. Immunity 2000;13:715-25
  • Kikly K, Liu L, Na S, Sedgwick JD. The IL-23/Th17 axis: therapeutic targets for autoimmune inflammation. Curr Opin Immunol 2006;18:670-5
  • Yawalkar N, Karlen S, Hunger R, Expression of interleukin-12 is increased in psoriatic skin. J Invest Dermatol 1998;111:1053-7
  • Lee E, Trepicchio WL, Oestreicher JL, Increased expression of interleukin 23 p14 and p40 in lesional skin of patients with psoriasis vulgaris. J Exp Med 2004;199:125-30
  • Windhagen A, Newcombe J, Dangond F, Expression of costimulatory molecules B7-1 (CD80), B7-2 (CD86), and interleukin 12 cytokine in multiple sclerosis lesions. J Exp Med 1995;182:1985-96
  • Li Y, Chu N, Hu A, Increased IL-23p19 expression in multiple sclerosis lesions and its induction in microglia. Brain 2007;130:490-501
  • Leonardi CL, Kimball AB, Papp KA, Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008;371:1665-74
  • Hong K, Chu A, Ludviksson BR, IL-12, independently of IFN-gamma, plays a crucial role in the pathogenesis of a murine psoriasis-like skin disorder. J Immunol 1999;162:7480-91
  • Leonard JP, Waldburger KE, Goldman SJ. Prevention of experimental autoimmune encephalomyelitis by antibodies against interleukin 12. J Exp Med 1995;181:381-6
  • Neurath MF, Fuss I, Kelsall BL, Antibodies to interleukin-12 abrogate established experimental colitis in mice. J Exp Med 1995;182:1281-90
  • Matthys P, Vermeire K, Miltera T, Anti-IL-12 antibody prevents the development and progression of collagen-induced arthritis in IFN-gamma receptor-deficeint mice. Eur J Immunol 1998;28:2143-51
  • Kauffman CL, Aria N, Toichi E, A Phase I study evaluating the safety, pharmacokinetics, and clinical response of a human IL-12 p40 antibody in subjects with plaque psoriasis. J Invest Dermatol 2004;123:1037-44
  • Gottlieb AB, Cooper KD, McCormick TS, A Phase 1, double-blind, placebo-controlled study evaluating single subcutaneous administrations of a human interleukin-12/23 monoclonal antibody in subjects with plaque psoriasis. Curr Med Res Opin 2007;23:1081-92
  • FDA Center for Drug Evaluation and Research, Dermatologic and Ophthalmic Drugs Advisory Committee, Washington, DC: US. Available from: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4361b1-01-FDA%20.pdf 2008 [Last accessed 24 February 2010]
  • Zhu Y, Hu C, Lu M, Population pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J Clin Pharmacol 2009;49:162-75
  • Papp KA, Langley RG, Lebwohl M, Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 2008;371:1675-84
  • Reddy M, Davis C, Wong J, Modulation of CLA, IL-12R, CD40L, and IL-2Ralpha expression and inhibition of IL-12, and IL-23-induced cytokine secretion by CNTO1275. Cell Immunol 2007;247:1-11
  • Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009;361:496-509
  • Griffiths CE, Barker JN. Pathogenesis and clinical features of psoriasis. Lancet 2007;370:263-71
  • Rapp SR, Feldman SR, Exum ML, Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999;41:401-7
  • Krueger G, Koo J, Lebwohl M, The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol 2001;137:280-4
  • Yawalkar N, Karlen S, Hunger R, Expression of interleukin-12 is increased in psoriatic skin. J Invest Dermatol 1998;111:1053-7
  • Lee E, Trepicchio WL, Oestreicher JL, Increased expression of interleukin 23 p14 and p40 in lesional skin of patients with psoriasis vulgaris. J Exp Med 2004;199:125-30
  • Piskin G, Sylva-Steenland RM, Bos JD, Teunissen MB. In vitro and in situ expression of IL-23 by keratinocytes in healthy skin and psoriasis lesions: enhanced expression in psoriatic skin. J Immunol 2006;176:1908-15
  • Capon F, Di Meglio P, Szaub J, Sequence variants in the genes for the interleukin-23 (IL-23R) and its ligand (IL-12B) confer protection against psoriasis. Hum Genet 2007;122:201-6
  • Cargill M, Schrodi SJ, Chang M, A large-scale genetic association study confirms IL12B and leads to the identifcation of IL23R as psoriasis-risk genes. Am J Hum Genet 2007;80:273-90
  • Liu Y, Helms C, Liao W, A genome-wide association study of psoriasis and psoriatic arthritis identifies new disease loci. PLOS Genet 2008;4:e10000041
  • Nair RP, Duffin KC, Helms C, Genome-wide scan reveals association of psoriasis with IL-23 and NF-κB pathways. Nat Genet 2009;41:199-204
  • Fredriksson T, Pettersson U. Severe psoriasis – oral therapy with a new retinoid. Dermatologica 1978;157:238-44
  • Toichi E, Torres G, McCormick TS, An anti-IL-12p40 Antibody down-regulates type 1 cytokines, chemokines, and IL-12/IL-23 in psoriasis. J Immunol 2006;177:4917-26
  • Krueger GC, Langley RG, Leonardi C, A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med 2007;356:580-92
  • Finlay AY, Khan GK. Dermatology life quality index – a simple practical measure for routine clinical use. Clin Exp Dermatol 1994;19:210-6
  • Griffiths CE, Strober B, van der Kerkoff PC, Comparison of Ustekinumab and Etanercept for moderate-to-severe psoriasis. NEJM 2010;362:118-28
  • Lebwohl M, Schenkel B, Han C, Ustekinumab significantly improves health-related quality of life in ipatients with moderate to sever psoriasis [abstract no. FP 1362]. 17th Congress of the European Academy of Dermatology and Venereology, Paris; 2008
  • Reich K, Lebwohl M, Schenkel B, Ustekinumab improves work productivity and decreases workdays missed due to psoriasis in patients with moderate to severe psoriasis [abstract no. PSS44]. Value Health 2008;11:A298
  • Kim YK, Suh IB, Kim H, The plasma levels of interleukin-12 in schizophrenia, major depression, and bipolar mania: effects of psychotropic drugs. Mol Psychiatry 2002;7:1107-14
  • Guenther L, Han C, Schenkel B, Impact of ustekinumab on quality of life and sexual difficulties associated with psoriasis: results from Phase 3 clinical trials. Poster P1184, EADV Annual Congress, Berlin; 2009
  • Szodoray P, Alex P, Chappell-Woodward CM, Circulating cytokines in Norwegian patients with psoriatic arthritis determined by a multiplex cytokine array system. Rheumatology 2007;46:417-25
  • Rahman P, Inman RD, Maksymowych WP, Association of interleukin 23 receptor variants with psoriatic arthritis. J Rheumaol 2009;36:137-40
  • Sato K, Suermatsu A, Okamoto K, Th17 functions as an osteoclastogenic helper T cell subset that links T cell activation and bone destruction. J Exp Med 2006;203:2673-82
  • Yago T, Nanke Y, Kawamoto M, IL-23 induces human osteoclastogenesis via IL-17 in vitro, and anti-IL-23 antibody attenuates collagen-induced arthritis in rats. Arthritis Res Ther 2007;9:R96
  • Malfait AM, Butler DM, Presky DH, Blockade of IL-12 during the induction of collagen-induced arthritis (CIA) markedly attenuates the severity of arthritis. Clin Exp Immunol 1998;111:377-83
  • Gottlieb A, Menter A, Mendelsohn A, Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet 2009;373:633-40
  • Fries JF, Spitz P, Kraines G, Holman H. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45
  • Noseworthy JH, Lucchinetti C, Rodriguez M, Multiple scleroisis. N Engl J Med 2000;343:938-52
  • Martin R, McFarland HF. Immunological aspects of experimental allergic encephalomyelitis and multiple sclerosis. Crit Rev Clin Lab Sci 1995;32:121-82
  • Weber MS, Hohlfeld R, Zamvil SS. Mechanism of action of glatiramer acetate in treatment of multiple sclerosis. Neurother 2007;4:647-53
  • Miller DH, Khan OA, Sheremata WA, A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2003;348:15-23
  • Li J, Gran B, Zhang GX, Differential expression and regulation of IL-23 and IL-12 subunits and receptors in adult mouse microglia. J Neurol Sci 2003;215:95-103
  • Segal BM, Shevach EM. IL-12 unmasks latent autoimmune disease in resistant mice. J Exp Med 1996;184:771-5
  • Cua DJ, Sherlock J, Chen YI, Interleukin-23 rather than interleukin-12 is the critical cytokine for autoimmune inflammation of the brain. Nature 2003;421:744-8
  • Balashov KE, Smith DR, Khory SJ, Increased interleukin 12 production in progressive multiple sclerosis: induction by activated CD4+T cells via CD40 ligand. Proc Natl Acad Sci USA 1997;94:599-03
  • Vaknin-Dembinsky A, Balashov K, Weiner HL. IL-23 is increased in dendritic cells in multiple sclerosis and down-regulation of IL-23 by antisense oligos increases dendritic cell IL-10 production. J Immunol 2006;176:7768-74
  • Bagaeva LV, Williams LP, Segal BM. IL-12 dependent/IFNgamma independent expression of CCR5 by myelin-reactive T cells correlates with encephalitogenicity. J Neuroimmunol 2003;137:109-16
  • Deshpande P, King IL, Segal BM. IL-12 driven upregulation of P-selectin ligand on myelin-specific T cells is a critical step in an animal model of autoimmune demyelination. J Neuroimmunol 2006;173:35-44
  • Komiyama Y, Nakae S, Matsuki T, IL-17 plays an important role in the development of experimental autoimmune encephalomyelitis. J Immunol 2006;177:566-73
  • Ichikawa M, Koh CS, Inoue A, Anti-IL-12 antibody prevents the development and progression of multiple-sclerosis-like relapsing-remitting demyelinating disease in NOD mice induced with myelin oliodendrocyte glycoprotein peptide. J Neuroimmunol 2000;102:56-66
  • Brok HP, van Meurs M, Blezer E, Prevention of experimental autoimmune encephalomyelitis in common marmosets using an anti-IL-12p40 monoclonal antibody. J Immunol 2002;169:6554-63
  • ‘t Hart BA, Brok HP, Remarque E, Suppression of ongoing disease in a nonhuman primate model of multiple sclerosis by a human-anti-human IL-20p40 antibody. J Immunol 2005;175:4761-8
  • Kasper LH, Everitt D, Leist TP, A phase I trial of an interleukin-12/23 monoclonal antibody in relapsing multiple sclerosis. Curr Med Res Opin 2006;22:1671-8
  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disabililty status scale (EDSS). Neurology 1983;33:1444-52
  • Sipe JC, Knobler RL, Braheny SL, A neurologic rating scale (NRS) for use in multiple sclerosis. Neurology 1984;34:1368-72
  • Segal BM, Constantinescu CS, Raychaudhuri A, Repeated subcutaneous injections of IL12/23p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol 2008;7:796-804
  • Peluso I, Pallone F, Monteleone G. Interleukin-12 and Th1 immune response in Crohn's disease: pathogenetic relevance and therapeutic implication. World J Gastroenterol 2006;12:5606-10
  • Neurath MF. IL-23: a master regulator in Crohn disease. Nat Med 2007;133:26-8
  • Duerr RH, Taylor KD, Brant SR, A genome-wide association study identifies IL23R as an inflammatory bowel disease gene. Science 2006;314:1461-3
  • Yen D, Cheung J, Scheerens H, IL-23 is essential for T cell-mediated colitis and promotes inflammation via IL-17 and IL-6. J Clin Invest 2006;116:1310-6
  • Elson CO, Cong y, Weaver CT, Monoclonal anti-interleukin 23 reverses active colitis in a T cell-mediated model in mice. Gastroenterology 2007;132:2359-70
  • Sandborn WJ, Feagan BG, Fedorak RN, A randomized trial of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology 2008;135:1130-41
  • Toedter GP, Blank M, Lang Y, Relationship of C-reactive protein with clinical response after therapy with ustekinumab in Crohn's disease. Am J Gastroenterol 2009;104:2768-73
  • Gordon K, Leonardi C, Lebwohl M, The ustekinumab safety experience in patients with moderate-to-severe psoriasis: results from pooled analyses of Phase 2 and Phase 3 clinical trial data. Poster P 1170, EADV Annual Congress, Berlin; 2009
  • de Jong R, Altare F, Haagen IA, Severe mycobacterial and Salmonella infections in interleukin-12 receptor-deficient patients. Science 1998;280:1435-8
  • Fieschi C, Casanova JL. The role of interleukin-12 in human infectious diseases: only a faint signature. Eur J Immunol 2003;33:1461-4
  • Brunda MJ, Luistro L, Warrier RR, Antitumor and antimetastatic activity of interleukin 12 against murine tumors. J Exp Med 1993;178:1223-30
  • Cifaldi L, Quaglino E, Di Carol E, Alight, nontoxic interleukin 12 protocol inhibits HER-2/neu mammary carcinogenesis in BALB/c transgenic mice with established hyperplasia. Cancer Res 2001;61:2809-12
  • Langowski JL, Zhang X, Wu L, IL-23 promotes tumor incidence and growth. Nature 2006;442:461-165
  • Lee TS, Yen HC, Pan CC, Chau LY. The role of interleukin 12 in the development of atherosclerosis in ApoE-deficient mice. Arterioscler Thromb Vasc Biol 1999;19:734-42
  • Davenport P, Tipping PG. The role of interleukin-4 and interleukin-12 in the progression of atherosclerosis in apolipoprotein E-deficient mice. Am J Pathol 2003;163(3):1117-25
  • Hauer AD, Uyttenhove C, de Vos P, Blockade of interleukin-12 function by protein vaccination attenuates atherosclerosis. Circulation 2005;112:1054-62
  • Aicher A, Heeschen C, Mohaupt M, Nicotine strongly activates dendritic cell-mediated adaptive immunity: potential role for progression of atherosclerotic lesions. Circulation 2003;107:604-11
  • Youssef S, Stüve O, Patarroyo JC, The HMG-CoA reductase inhibitor, atorvastatin, promotes a Th2 bias and reverses paralysis in central nervous system autoimmune disease. Nature 2002;420:78-84
  • StelaraTM prescribing information. Horsham, PA: Centocor Ortho Biotech, Inc. 2009. Available from: http://www.stelarainfo.com/stelarainfo/assets/pdf/PrescribingInformation.pdf [Last accessed 24 February 2010]

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.