333
Views
7
CrossRef citations to date
0
Altmetric
Drug Profile

Ustekinumab: moving the target from psoriasis to Crohn's disease

, , &

References

  • Shivananda S, Lennard-Jones J, Logan R et al. Incidence of inflammatory bowel disease across Europe: is there a difference between the north and south? Results of the European Collaborative Study on Inflammatory Bowel Disease (EC-IBD). Gut 39, 690–697 (1996).
  • Hiatt RA, Kaufman l. Epidemiology of inflammatory bowel disease in a defined northern California population. Western J. Med. 149:541–546 (1988).
  • Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig. Dis. Sci. 58, 519–525 (2013).
  • Van Assche G, Dignass A, Panes J et al. The second European evidence-based consensus on the diagnosis and management of Crohn's disease: definitions and diagnosis. J. Crohns Colitis. 4, 7–27 (2010).
  • Reichert JM. Antibodies to watch in 2010. MAbs 2, 84–100 (2010).
  • Kristensen M, Chu CQ, Eedy DJ, Feldmann M, Brennan FM, Breathnach SM. Localization of tumor necrosis factor-alpha (TNFalpha) and its receptors in normal and psoriatic skin: epidermal cells express the 55-kD but not the 75-kD TNF receptor. Clin. Exp. Immunol. 94, 354–362 (1993).
  • Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol. Ther. 117, 244–279 (2008).
  • Kobayashi M, Fitz L, Ryan M et al. Identification and purification of natural killer cell stimulatory factor (NKSF), a cytokine with multiple biologic effects on human lymphocytes. J. Exp. Med. 170, 827–845 (1989).
  • Trinchieri G. Interleukin-12 and the regulation of innate resistance and adaptive immunity. Nat. Rev. Immunol. 3, 133–146 (2003).
  • Fiorentino DF, Bond MW, Mosmann TR. Two types of mouse T helper cell IV. Th2 clones secrete a factor that inhibits cytokine production by Th1 clones. J. Exp. Med. 170, 2081–2095 (1989).
  • Wilson NJ, Boniface K, Chan JR et al. Development, cytokine profile and function of human interleukin 17-producing helper T cells. Nat. Immunol. 8, 950–957 (2007).
  • Zhou L, Chong MM, Littman DR. Plasticity of CD4+ T cell lineage differentiation. Immunity 30, 646–655 (2009).
  • Neurath MF, Fuss I, Kelsall BL, Stüber E, Strober W. Antibodies to interleukin 12 abrogate established experimental colitis in mice. J. Exp. Med. 182, 1281–1290 (1995).
  • Duerr RH, Taylor KD, Brant SR et al. A genome-wide association study identifies IL23R as an inflammatory bowel disease gene. Science 314, 1461–1463 (2006).
  • Di Meglio P, Di Cesare A, Laggner U et al. The IL23R R381Q gene variant protects against immune-mediated diseases by impairing IL-23-induced Th17 effector response in humans. PLoS ONE 6, 17160 (2011).
  • Benson JM, Peritt D, Scallon BJ et al. Discovery and mechanism of ustekinumab A human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. MAbs 3, 535–545 (2011).
  • Luo J, Wu SJ, Lacy ER et al. Structural basis for dual recognition of IL-12 and IL-23 by ustekinumab. J. Mol. Biol. 402, 797–812 (2010).
  • Presky DH, Yang H, Minetti LJ et al. A functional interleukin 12 receptor complex is composed of two beta-type cytokine receptor subunits. Proc. Natl Acad. Sci. U.S.A. 93, 14002–14007 (1996).
  • Oppmann B, Lesley R, Blom B et al. Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12. Immunity 13, 715–725 (2000).
  • Parham C, Chirica M, Timans J et al. A receptor for the heterodimeric cytokine IL-23 is composed of IL-12Rbeta1 and a novel cytokine receptor subunit, IL-23R. J. Immunol. 168, 5699–5708 (2002).
  • Zhu Y, Hu C, Lu M et al. Population pharmacokinetic modelling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J. Clin. Pharmacol. 49, 162–175 (2009).
  • Kaufman CL, Aria N, Toichi E et al. A Phase I study evaluating the safety, pharmacokinetics, and clinical response of a human IL-12p40 antibody in subjects with plaque psoriasis. J. Invest. Dermatol. 123, 1037–1044 (2004).
  • Gottlieb AB, Cooper KD, McCormick TS et al. A Phase I, double-blind, placebo-controlled study evaluating single subcutaneous administration of human interleukin-12/23 monoclonal antibody in subjects with plaque psoriasis. Curr. Med. Res. Opin. 23, 1081–1092 (2007).
  • Krueger GG, Langley RG, Leonardi C et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N. Engl. J. Med. 356, 580–592 (2007).
  • Gottlieb A, Menter A, Mendelsohn A et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet 373, 633–640 (2009).
  • Leonardi CL, Kimball AB, Papp KA et al. Efficacy and safety of Ustekinumab, a human interleukin 12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomized, double blind, placebo-controlled trial (PHOENIX1). Lancet 371, 1665–1674 (2008).
  • Papp KA, Langely RG, Lebwohl M et al. Efficacy and safety of ustekinumab, a human interleukin 12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomized, double blind, placebo-controlled trial (PHOENIX2). Lancet 371, 1675–1684 (2008).
  • Griffiths CEM, Strober B, van de Kerkhof PCM et al. A Phase III multicenter, randomized study comparing ustekinumab and etanercept for the treatment of moderate to severe plaque psoriasis. European Academy of Dermatology and Venerology Annual Congress Paris. FP1336(2008).
  • McInnes IB, Kavanaugh A, Gottlieb AB et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet 382(9894), 780–789 (2013).
  • Sandborn WJ, Feagan B, Fedorak RN et al. A randomized trial of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology 135, 1130–1141 (2008).
  • Cingoz O. Ustekinumab. MAbs 1(3), 216–221 (2009).
  • Sandborn WJ, Gasink C, Gao LL et al. A multicenter, randomized, double-blind, placebo-controlled phase 2b study of ustekinumab, a human monoclonal antibody to IL-12/23p40, in patients with moderately to severely active Crohn's disease: results through week 22 from the CERTIFI Trial. Gastroenterology 140, 109 (2011).
  • Sandborn WJ, Gasink C, Gao LL et al. Ustekinumab Induction and Maintenance Therapy in Refractory Crohn’s Disease. N. Engl. J. Med. 367, 1519–1528 (2012).
  • Cleynen I, Vermeire S. Paradoxical inflammation induced by anti-TNF agents in patients with IBD. Nat. Rev. Gastroenterol. Hepatol. 9, 496–503 (2012).
  • Tillack C, Ehmann LM, Friedrich M et al. Anti-TNF antibody-induced psoriasiform skin lesions in patients with inflammatory bowel disease are characterised by interferon-γ-expressing Th1 cells and IL-17A/IL-22-e(2013)xpressing Th17 cells and respond to anti-IL-12/IL-23 antibody treatment. Gut (2013) ( Epub ahead of print).
  • Lebwohl M, Leonardi C, Griffiths CEM et al. Long-term safety experience of ustekinumab on patients with moderate-to-severe psoriasis (Part I of II): results from analyses of general safety parameters from pooled phase II and III clinical trials. J. Am. Acad. Dermatol. 66, 731–741 (2012).
  • Gordon KB, Papp KA, Langley RG et al. Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (part II of II): results from analyses of infections and malignancy from pooled phase II and III clinical trials. J. Am. Acad. Dermatol. 66, 742–751 (2012).
  • O'Neill JL, Kalb RE. Ustekinumab in the therapy of chronic plaque psoriasis. Biologics 3, 159–168 (2009).
  • Tzellos T, Kyrgidis A, Zomboulis CC. Re-evaluation of the risk for major adverse cardiovascular events in patients treated with IL-12/23 biologic agents for chronic plaque psoriasis: a meta-analysis of randomized controlled trials. J. Am. Acad. Dermatol. Venereol. 27, 622–627 (2013).
  • Sands BE, Jacobson EW, Sylwestrowicz T et al. Randomized, double-blind, placebo-controlled trial of the oral interleukin-12/23 inhibitor apilimod mesylate for treatment of active Crohn's disease. Inflamm. Bowel Dis. 16, 1209–1218 (2010).

Websites

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.