Review of the safety and efficacy of ustekinumab

Therapeutic Advances in Gastroenterology

Volumn 3, Issue 5, 2010, Pages 321-328

  Scherl, Ellen J ^a   Kumar, Sheila ^b   Warren, Ryan U ^c  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b NewYork Presbyterian Hospital ^*  (United States)

^c BROWN UNIVERSITY   (United States)

Author keywords

Anti interleukin 12 23; Antitumor necrosis factor; Crohn's disease; Infliximab; Primary nonresponder; Secondary nonresponder; Suboptimal infliximab response; Ustekinumab

Indexed keywords

ABT 874; C REACTIVE PROTEIN; GAMMA INTERFERON; HUMAN MONOCLONAL ANTIBODY; INFLIXIMAB; INTERLEUKIN 12; PARAPROTEIN; PLACEBO; USTEKINUMAB;

ANXIETY; ARTHRALGIA; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CROHN DISEASE; DISEASE EXACERBATION; DRUG ABSORPTION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; HEADACHE; HUMAN; MULTIPLE SCLEROSIS; NAUSEA; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; PSORIASIS; REMISSION; RESPIRATORY TRACT INFECTION; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; TREATMENT RESPONSE;

EID: 77956241170     PISSN: 1756283X     EISSN: None     Source Type: Journal    
DOI: 10.1177/1756283X10374216     Document Type: Review

References (27)

1. Abraham, C. and Cho, J.H. ( 2009) Inflammatory bowel disease. N Engl J Med 361: 2066-2078.
2. Barrett, J.C., Hansoul, S., Nicolae, D.L., Cho, J.H., Duerr, R.H., Rioux, J.D. et al. (2008) Genome-wide association defines more than 30 distinct susceptibility loci for Crohn's disease. Nat Genet 40: 955-962.
3. Cargill, M., Schrodi, S.J., Chang, M., Garcia, V.E., Brandon, R., Callis, K.P. et al. (2007) A large-scale genetic association study confirms IL12B and leads to the identification of IL23R as psoriasis-risk genes. Am J Hum Genet 80: 273-290.
4. Cho, J.H. ( 2008) The genetics and immunopathogenesis of inflammatory bowel disease. Nature 8: 458-466.
5. Colombel, J.F., Sandborn, W.J., Rutgeerts, P., Enns, R., Hanauer, S.B., Panaccione, R. et al. (2007) Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: The CHARM trial. Gastroenterology 132: 52-65.
6. Duerr, R.H., Taylor, K.D., Brant, S.R., Rioux, J.D., Silverberg, M.S., Daly, M.J. et al. (2006) A genome-wide association study identifies IL23R as an inflammatory bowel disease gene. Science 314: 1461-1463.
7. Hanauer, S.B., Feagan, B.G., Lichtenstein, G.R., Mayer, L.F., Schreiber, S., Colombel, J.F. et al. (2002) Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 359: 1541-1549.
8. Hanauer, S.B., Sandborn, W.J., Rutgeerts, P., Fedorak, R.N., Lukas, M., MacIntosh, D. et al. (2006) Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology 130: 323-333.
9. Iwakura, Y. and Ishigame, H. ( 2006) The IL-23/IL-17 axis in inflammation. J Clin Invest 116: 1218-1222.
10. Kasper, L.H., Everitt, D., Leist, T.P., Ryan, K.A., Mascelli, M.A., Johnson, K. et al. (2006) A phase I trial of an interleukin-12/23 monoclonal antibody in relapsing multiple sclerosis. Curr Med Res Opin 22: 1671-1678.
11. Keino, H., Watanabe, T., Sato, Y., Niikura, M., Wada, Y. and Okada, A.A. ( 2008) Therapeutic effect of the potent IL-12/IL-23 inhibitor STA-5326 on experimental autoimmune uveoretinitis. Arthritis Res Ther 10: R122.
12. Kimball, A.B., Gordon, K.B., Langley, R.G., Menter, A., Chartash, E.K. and Valdes, J. ABT-874 Psoriasis Study Investigators. (2008 ) Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol 144: 200-207.
13. Leonardi, C.L., Kimball, A.B., Papp, K.A., Yeilding, N., Guzzo, C., Wang, Y. et al. (2008) 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 371: 1665-1674.
14. Mannon, P.J., Fuss, I.J., Mayer, L., Elson, C.O., Sandborn, W.J., Present, D. et al. (2004) Anti-interleukin-12 antibody for active Crohn's disease. N Engl J Med 351: 2069-2079.
15. Monteleone, G., Biancone, L., Marasco, R., Morrone, G., Marasco, O., Luzza, F. et al. (1997) Interleukin 12 is expressed and actively released by Crohn's disease intestinal lamina propria mononuclear cells. Gastroenterology 112: 1169-1178.
16. Papp, K.A., Langley, R.G., Lebwohl, M., Krueger, G.G., Szapary, P., Yeilding, N. et al. (2008) 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 371: 1675-1684.
17. Parronchi, P., Romagnani, P., Annunziato, F., Sampognaro, S., Becchio, A., Giannarini, L. et al. (1997) Type 1 T-helper cell predominance and interleukin-12 expression in the gut of patients with Crohn's disease. Am J Pathol 150: 823-832.
18. Rutgeerts, P., Feagan, B.G., Lichtenstein, G.R., Mayer, L.F., Schreiber, S., Colombel, J.F. et al. (2004) Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease. Gastroenterology 126: 402-413.
19. Sandborn, W.J., Feagan, B.G., Fedorak, R.N., Scherl, E., Fleisher, M.R., Katz, S. et al. (2008) 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.
20. Sandborn, W.J., Feagan, B.G., Stoinov, S., Honiball, P.J., Rutgeerts, P., Mason, D. et al. (2007 a) Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med 357: 228-238.
21. Sandborn, W.J., Rutgeerts, P., Enns, R., Hanauer, S.B., Colombel, J.F., Panaccione, R. et al. (2007 b) Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 146: 829-838.
22. Sands, B.E., Jacobson, E.W., Sylwestrowicz, T., Younes, Z., Dryden, G., Fedorak, R. et al. (2009) 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. DOI: 10.1002/ibd.21159.
23. Schreiber, S., Khaliq-Kareemi, M., Lawrance, I.C., Thomsen, O., Hanauer, S.B., McColm, J. et al. (2007) Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med 357: 239-250.
24. Segal, B.M., Constantinescu, C.S., Raychaudhuri, A., Kim, L., Fidelus-Gort, R. and Kasper, L.H.; Ustekinumab MS Investigators (2008) Repeated subcutaneous injections of IL12/23 p 40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol 7: 796-804.
25. Targan, S.R., Hanauer, S.B., van Deventer, S.J., Mayer, L., Present, D.H., Braakman, T. et al. Crohn's Disease cA 2 Study Group. ( 1997) A short-term study of chimeric monoclonal antibody cA 2 to tumor necrosis factor alpha for Crohn's disease. N Engl J Med 337: 1029-1035.
26. Toedter, G.P., Blank, M., Lang, Y., Chen, D., Sandborn, W.J. and de Villiers, W.J. (2009) Relationship of C-reactive protein with clinical response after therapy with ustekinumab in Crohn's disease. Am J Gastroenterol 104: 2768-2773.
27. Trinchieri, G., Pflanz, S. and Kastelein, R.A. ( 2003) The Il-12 Family of Heterodimeric Cytokines: New Players in the Regulation of T Cell Responses. Immunity 19: 641-644.