Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease

Cochrane Database of Systematic Reviews

Volumn 2015, Issue 5, 2015, Pages

  Khanna, Reena ^a   Preiss, Jan C ^b   Macdonald, John K ^a   Timmer, Antje ^c  

^a ROBARTS RESEARCH INSTITUTE   (Canada)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^c UNIVERSITY OF OLDENBURG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BRIAKINUMAB; INTERLEUKIN 12; INTERLEUKIN 12P40; INTERLEUKIN 23; INTERLEUKIN 23P40; PLACEBO; UNCLASSIFIED DRUG; USTEKINUMAB; MONOCLONAL ANTIBODY;

CROHN DISEASE; CROHN DISEASE ACTIVITY INDEX; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EVIDENCE BASED MEDICINE; HUMAN; INFECTION; INJECTION SITE REACTION; INTENTION TO TREAT ANALYSIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REMISSION; REVIEW; SINGLE DRUG DOSE; SYSTEMATIC REVIEW; ANTAGONISTS AND INHIBITORS; IMMUNOLOGY; INTRAVENOUS DRUG ADMINISTRATION; META ANALYSIS; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; CROHN DISEASE; HUMANS; INJECTIONS, INTRAVENOUS; INTERLEUKIN-12; INTERLEUKIN-23; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REMISSION INDUCTION;

EID: 84945385596     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD007572.pub2     Document Type: Review

References (65)

1. Mannon P, Fuss I, Mayer L, Elson CO, Sandborn WJ, Dolin B, et al. Anti-interleukin-12 treats active Crohn's disease. Gastroenterology 2004;126(4 Suppl 2):A22-3.
2. Mannon PJ, Fuss IJ, Mayer L, Elson CO, Sandborn WJ, Present D, et al. Anti-interleukin-12 antibody for active Crohn's disease. New England Journal of Medicine 2004;351(20):2069-79.
3. Panaccione R, Sandborn W, Gordon G, Lee S, Safdi A, Sedghi S, et al. Briakinumab (anti-interleukin 12/23p40, ABT874) for treatment of Crohn's disease. American Journal of Gastroenterology 2010;105(Supp 1):S457-8.
4. Sandborn W, Feagan B, Fedorak R, Scherl E, Fleisher M, Katz S, et al. A multicenter, randomized, phase 2A study of human monoclonal antibody to IL- 12/23P40 (CNTO 1275) in patients with moderately to severely active Crohn' disease. Inflammatory Bowel Diseases 2008;14(Supp 1):S10.
5. Sandborn WJ, Feagan BG, Fedorak R, Scherl E, Fleisher M, Katz S, et al. A multicenter, randomized, phase 2a study of human monoclonal antibody to IL-12/23p40 (CNTO 1275) in patients with moderately to severely active Crohn's disease. Gastroenterology 2007;132(4 Suppl 1):A51.
6. Sandborn WJ, Feagan BG, Fedorak RN, Scherl E, Fleisher MR, Katz S, et al. A randomized trial of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology 2008;135(4):1130-41.
7. Toedter GP, Blank M, Lang Y, Chen D, Sandborn WJ, de Villiers WJ. Relationship of C-reactive protein with clinical response after therapy with ustekinumab in Crohn's disease. American Journal of Gastroenterology 2009;104(11):2768-73.
8. Feagan B, Gasink C, Gao L, Blank M, Johanns J, Guzzo C, 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 36 from the CERTIFI trial. American Journal of Gastroenterology 2011;106(Supp 2s):S463.
9. Feagan B, Gasink C, Gao LL, Blank M, Johanns J, Guzzo C, et al. Health related quality of life results through week 22 from the CERTIFI study, a multicenter, randomized, double-blind, placebo-controlled Phase2b study of ustekinumab in patients with moderately to severely active Crohn's disease. Journal of Crohn's and Colitis 2012;6(Supp 1):S129-30.
10. Gasink C, Chan D, Gao LL, Schenkel B, Han C. Assessment of sleep impairment in patients with Crohn's disease: Results from the ustekinumab CERTIFI study. Gastroenterology 2013;144(5 Suppl 1):S231.
11. Sandborn WJ, Gasink C, Gao LL, Blank M, Johanns J, Guzzo C, et al. A multicenter, randomized, double-blind, placebo-controlled Phase2b 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 2011;140(5 Suppl 1):S109.
12. Sandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, et al. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. New England Journal of Medicine 2012;367(16):1519-28.
13. Sands BE, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, et al. Health related quality of life results through week 22 from the CERTIFI study, a multicenter, randomized, double-blind, placebo-controlled phase2b study ofUstekinumab in patients with moderately to severely active Crohn's disease. Inflammatory Bowel Diseases 2011;17(Supp 2):S24.
14. Toedter G, Wu X, Gao LL, Gasink C. Reductions in fecal calprotectin and lactoferrin following ustekinumab induction therapy in patients with moderate to severe Crohn's disease who have previously failed or been intolerant of TNF antagonist therapies. Gastroenterology 2011;140(5 Suppl 1):S264.
15. Fasanmade AA, Adedokun OJ, Johanns JR, Zhou H, Davis HM, Blank, M Pharmacokinetics and exposure-response relationship of ustekinumab, a human monoclonal antibody to interleukin 12/23 in patients with moderate-to-severe Crohn's disease. Gastroenterology 2008;134(4 Suppl 1):A-490.
16. Sands BE, Jacobson EW, Sylwestrowicz T, Younes Z, Dryden G, Fedorak R, et al. Randomized, double-blind, placebo-controlled trial of the oral interleukin-12/23 inhibitor apilimod mesylate for treatment of active Crohn's disease. Inflammatory Bowel Diseases 2010;16(7):1209-18.
17. NCT01369329 A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to TNF antagonist therapy (UNITI-1). clinicaltrials.gov/ct2/show/NCT01369329 (accessed March 31, 2015).
18. NCT01369342 A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects with moderately to severely active Crohn's disease (UNITI-2). clinicaltrials.gov/ct2/show/NCT01369342 (accessed 31 March 2015).
19. NCT01369355 A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab maintenance therapy in subjects with moderately to severely active Crohn's disease. clinicaltrials.gov/ct2/show/NCT01369355 (accessed 31 March 2015).
20. Akobeng AK, Zachos M. Tumor necrosis factor-alpha antibody for induction of remission in Crohn's disease. Cochrane Database of Systematic Reviews 2003, Issue 4. [DOI: 10.1002/14651858.CD003574.pub2]
21. Benson JM, Sachs CW, Treacy G, Zhou H, Pendley CE, Brodmerkel CM, et al. Therapeutic targeting of the IL-12/23 pathways: generation and characterization of ustekinumab. Nature Biotechnology 2011;29(7):615-24.
22. Burmester GR, Panaccione R, Gordon KB, McIlraith MJ, Lacerda AP. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease. Annals of the Rheumatic Diseases 2013;72(4):517-24.
23. Chande N, Tsoulis DJ, MacDonald JK. Azathioprine or 6-mercaptopurine for induction of remission in Crohn's disease. Cochrane Database of Systematic Reviews 2013, Issue 4. [DOI: 10.1002/14651858.CD000545.pub4]
24. Cingoz, O Ustekinumab. Monoclonal Antibodies 2011;1(3):216-221.
25. Colombel JF, Loftus EV Jr, Tremaine WJ, Egan LJ, Harmsen WS, Schleck CD, et al. The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients. Gastroenterology 2004;126(1):19-31.
26. Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007;132(1):52-65.
27. Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. New England Journal of Medicine 2010;362(15):1383-95.
28. Danese S, Fiorino G, Reinisch W. Review article: Causative factors and the clinical management of patients with Crohn's disease who lose response to anti-TNF-α therapy. Alimentary Pharmacology and Therapeutics 2011;34(1):1-10.
29. Duvallet E, Semerano L, Assier E, Falgarone G, Boissier MC. Interleukin-23: a key cytokine in inflammatory diseases. Annals of Medicine 2011;43(7):503-11.
30. Faubion WA Jr, Loftus EV Jr, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of corticosteroid therapy for inflammatory bowel disease: a population-based study. Gastroenterology 2001;121(2):255-60. [PUBMED: 11487534]
31. Ford AC, Bernstein CN, Khan KJ, Abreu MT, Marshall JK, Talley NJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. American Journal of Gastroenterology 2011;106(4):590-9.
32. Fuss IJ, Marth T, Neurath MF, Pearlstein GR, Jain A, Strober W. Anti-interleukin 12 treatment regulates apoptosis of Th1 T cells in experimental colitis in mice. Gastroenterology 1999;117(5):1078-88. [PUBMED: 10535870]
33. Gottlieb A, Menter A, Mendelsohn A, Shen YK, Li S, Guzzo C, et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet 2009;373(9664):633-40. [PUBMED: 19217154]
34. Gottlieb AB, Kalb RE, Langley RG, Krueger GG, de Jong EM, Guenther L, et al. Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): experience with infliximab and other systemic and biologic therapies. Journal of Drugs in Dermatology 2014;13(12):1441-8.
35. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336(7650):924-6.
36. Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002;359(9317):1541-9.
37. Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology 2006;130(2):323-33.
38. Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
39. Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
40. Hudesman D, Lichtiger S, Sands B. Risk of extraintestinal solid cancer with anti-TNF therapy in adults with inflammatory bowel disease: review of the literature. Inflammatory Bowel Diseases 2013;19(3):644-649.
41. Khanna R, Feagan BG. Ustekinumab for the treatment of Crohn's disease. Immunotherapy 2013;5(8):803-15.
42. Lawson MM, Thomas AG, Akobeng AK. Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database of Systematic Reviews 2006, Issue 3. [DOI: 10.1002/14651858.CD005112.pub2]
43. Loke YK, Price D, Herxheimer A, Cochrane Adverse Effects Methods Group. Systematic reviews of adverse effects: framework for a structured approach. BMC Medical Research Methodology 2007;7:32.
44. McDonald JWD, Tsoulis DJ, MacDonald JK, Feagan BG. Methotrexate for induction of remission in refractory Crohn's disease. Cochrane Database of Systematic Reviews 2012, Issue 12. [DOI: 10.1002/14651858.CD003459.pub3]
45. ModiglianiR, Mary JY, Simon JF, Cortot A, Soule JC, Gendre JP, et al. Clinical, biological, and endoscopic picture of attacks of Crohn's disease. Evolution on prednisolone. Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives. Gastroenterology 1990;98(4):811-8.
46. Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology 2012;142(1):46-54.e42; quiz e30. [PUBMED: 22001864]
47. Neurath MF, Fuss I, Kelsall BL, Stuber E, Strober W. Antibodies to interleukin 12 abrogate established experimental colitis in mice. Journal of Experimental Medicine 1995;182(5):1281-90. [PUBMED: 7595199]
48. Niederreiter L, Adolph TE, Kaser A. Anti-IL-12/23 in Crohn's disease: bench and bedside. Current Drug Targets 2013;14(12):1379-84.
49. Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N, et al. 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(9625):1675-84. [PUBMED: 18486740]
50. Papp KA, Griffiths CE, Gordon K, Lebwohl M, Szapary PO, Wasfi Y, et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. British Journal of Dermatology 2013;168(4):844-54.
51. Peluso I, Pallone F, Monteleone G. Interleukin-12 and Th1 immune response in Crohn's disease: pathogenetic relevance and therapeutic implication. World Journal of Gastroenterology 2006;12(35):5606-10.
52. Raj LS, Hawthorne AB. Optimising use of thiopurines in inflammatory bowel disease. Frontline Gastroenterology 2010;1:44-51.
53. Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, et al. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. New England Journal of Medicine 2011;365(17):1586-96.
54. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008.
55. Rutgeerts P, Löfberg R, Malchow H, Lamers C, Olaison G, Jewell D, et al. A comparison of budesonide with prednisolone for active Crohn's disease. New England Journal of Medicine 1994;331(13):842-5.
56. Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, et al. Certolizumab pegol for the treatment of Crohn's disease. New England Journal of Medicine 2007;357(3):228-38.
57. Schreiber S, Khaliq-Kareemi M, Lawrance IC, Thomsen OØ, Hanauer SB, McColm J, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. New England Journal of Medicine 2007;357(3):239-50.
58. Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ, Glasziou P, et al. Chapter 12: Interpreting results and drawing conclusions. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
59. Singh JA, Wells GA, Christensen, Ghogomu ET, Maxwell L, MacDonald JK, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane database of systematic reviews 2011;2:CD008794.
60. Singh S, Garg SK, Pardi DS, Wang Z, Murad MH, Loftus EV Jr. Comparative efficacy of biologic therapy in biologic-naive patients with Crohn disease: a systematic review and network meta-analysis. Mayo Clinic Proceedings 2014;89(12):1621-35.
61. Solberg IC, Vatn MH, Hoie O, Stray N, Sauar J, Jahnsen J, et al. Clinical course in Crohn's disease: results of a Norwegian population-based ten-year follow-up study. Clinical Gastroenterology and Hepatology 2007;5(12):1430-8.
62. Summers RW, Switz DM, Sessions JT Jr, Becktel JM, Best WR, Kern F Jr, et al. National Cooperative Crohn's Disease Study: results of drug treatment. Gastroenterology 1979;77(4 Part 2):847-69.
63. Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. New England Journal of Medicine 1997; 337(15):1029-35.
64. Watanabe T, Kitani A, Murray PJ, Strober W. NOD2 is a negative regulator of Toll-like receptor 2-mediated T helper type 1 responses. Nature Immunology 2004;5(8):800-8.
65. Yang YX, Lichtenstein GR. Corticosteroids in Crohn's disease. American Journal of Gastroenterology 2002;97(4):803-23.