The Next Wave of Biological Agents for the Treatment of IBD: Evidence from Cochrane Reviews

Inflammatory Bowel Diseases

Volumn 22, Issue 7, 2016, Pages 1737-1743

  Khanna, Reena ^a,b   Chande, Nilesh ^a   Vermeire, Séverine ^c   Sandborn, William J ^d   Parker, Claire E ^b   Feagan, Brian G ^a,b  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b ROBARTS RESEARCH INSTITUTE   (Canada)

^c UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Crohn's disease; immunogenicity; monoclonal antibody; ulcerative colitis

Indexed keywords

BIOLOGICAL PRODUCT; ETROLIZUMAB; MUCOSAL ADDRESSIN CELL ADHESION MOLECULE 1; MUCOSAL ADDRESSIN CELL ADHESION MOLECULE 1 ANTIBODY; PROTEIN ANTIBODY; UNCLASSIFIED DRUG; USTEKINUMAB; VEDOLIZUMAB; GASTROINTESTINAL AGENT; IMMUNOGLOBULIN; MADCAM1 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; MUCOPROTEIN;

ABDOMINAL PAIN; ARTHRALGIA; COCHRANE LIBRARY; CROHN DISEASE; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; FATIGUE; HEADACHE; HUMAN; IMMUNOGENICITY; LEUKOCYTE MIGRATION; LISTERIOSIS; NAUSEA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; REVIEW; RHINOPHARYNGITIS; ULCERATIVE COLITIS; UPPER RESPIRATORY TRACT INFECTION; ANTAGONISTS AND INHIBITORS; DRUG EFFECTS; EVIDENCE BASED MEDICINE; IMMUNOLOGY; LITERATURE; LYMPHOCYTE; MAINTENANCE CHEMOTHERAPY; ORGANIZATION; PHYSIOLOGY;

ANTIBODIES, MONOCLONAL, HUMANIZED; BIOLOGICAL PRODUCTS; COLITIS, ULCERATIVE; CONGRESSES AS TOPIC; CROHN DISEASE; EVIDENCE-BASED MEDICINE; GASTROINTESTINAL AGENTS; HUMANS; IMMUNOGLOBULINS; LYMPHOCYTES; MAINTENANCE CHEMOTHERAPY; MUCOPROTEINS; REMISSION INDUCTION; REVIEW LITERATURE AS TOPIC; USTEKINUMAB;

EID: 84976321027     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1097/MIB.0000000000000808     Document Type: Review

References (58)

1. Mosli MH, Rivera-Nieves J, Feagan BG. T-cell trafficking and antiadhesion strategies in inflammatory bowel disease: current and future prospects. Drugs. 2014;74:297-311
2. Polman CH, O'Connor PW, Havrdova E, et al. A randomized, placebocontrolled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006;354:899-910
3. Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med. 2005;353:369-374
4. Langer-Gould A, Atlas SW, Green AJ, et al. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med. 2005;353:375-381
5. Van Assche G, Van Ranst M, Sciot R, et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N Engl J Med. 2005;353:362-368
6. Lobaton T, Vermeire S, Van Assche G, et al. Review article: anti-adhesion therapies for inflammatory bowel disease. Aliment Pharmacol Ther. 2014; 39:579-594
7. Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med. 2005;353:1912-1925
8. Bickston SJ, Behm BW, Tsoulis DJ, et al. Vedolizumab for induction and maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2014;8:CD007571
9. Khanna R, Mosli Mahmoud H, Lam MCW, et al. Vedolizumab for induction and maintenance of remission in Crohn's disease. Cochrane Database Syst Rev. 2015;3:CD011615
10. Rosenfeld G, Bressler B, Parker CE, et al. Anti-MAdCAM antibody for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2015;6:CD011743
11. Rosenfeld G, Parker CE, MacDonald JK, et al. Etrolizumab for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2015;4: CD011661
12. Feagan BG, McDonald J, Greenberg G, et al. An ascending dose trial of a humanized A4 B7 antibody in ulcerative colitis (UC). Gastroenterology. 2000;118:A874
13. Feagan BG, Greenberg GR, Wild G, et al. Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin. N Engl J Med. 2005;352:2499-2507
14. Parikh A, Leach T, Wyant T, et al. Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis. 2012;18:1470-1479
15. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699-710
16. Rutgeerts PJ, Fedorak RN, Hommes DW, et al. A randomised phase I study of etrolizumab (rhuMAb beta7) in moderate to severe ulcerative colitis. Gut. 2013;62:1122-1130
17. Vermeire S, O'Byrne S, Keir M, et al. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014; 384:309-318
18. Vermeire S, Ghosh S, Panes J, et al. The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study. Gut. 2011;60:1068-1075
19. Vermeire S, Sandborn W, Danese S, et al. OP021. TURANDOT: a randomized, multicenter double-blind, placebo-controlled study of the safety and efficacy of Anti-MAdCAM Antibody PF-00547659 (PF) in patients with moderate to severe Ulcerative Colitis (UC). J Crohn's Colitis. 2015;9:S13
20. Feagan BG, Greenberg GR, Wild G, et al. Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin. Clin Gastroenterol Hepatol. 2008;6:1370-1377
21. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013;369: 711-721
22. Sands BE, Feagan BG, Rutgeerts P, et al. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment had failed. Gastroenterology. 2014;147: 618-627.e3
23. 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. 2011;3:535-545
24. Cingoz O. Ustekinumab. MAbs. 2009;1:216-221
25. Mannon PJ, Fuss IJ, Mayer L, et al. Anti-interleukin-12 antibody for active Crohn's disease. N Engl J Med. 2004;351:2069-2079
26. Ryan C, Thrash B, Warren RB, et al. The use of ustekinumab in autoimmune disease. Expert Opin Biol Ther. 2010;10:587-604
27. Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007;448:427-434
28. Kurzeja M, Rudnicka L, Olszewska M. New interleukin-23 pathway inhibitors in dermatology: ustekinumab, briakinumab, and secukinumab. Am J Clin Dermatol. 2011;12:113-125
29. 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;12:5606-5610
30. Iwakura Y, Ishigame H. The IL-23/IL-17 axis in inflammation. J Clin Invest. 2006;116:1218-1222
31. Kauffman CL, Aria N, Toichi E, et al. 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;123:1037-1044
32. Krueger GG, Langley RG, Leonardi C, et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007; 356:580-592
33. 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 randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371:1665-1674
34. Papp KA, Langley 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 randomised, double-blind, placebocontrolled trial (PHOENIX 2). Lancet. 2008;371:1675-1684
35. Agency EM. Available at: http://www.ema.europa.eu/docs/en-GB/document- library/EPAR-Product-Information/human/000958/WC500058513.pdf
36. Administration UFaD. Available at: http://www.accessdata.fda.gov/ scripts/cder/drugsatfda/index.cfm?fuseactionandfrac14;Search.DrugDetails
37. Canada H. Available at: http://www.hc-sc.gc.ca/dhp-mps/medeff/reviewsexamens/ stelara-eng.php
38. Khanna R, Preiss JC, MacDonald JK, et al. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2015;5:Cd007572
39. Sandborn WJ, Feagan BG, 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. 2008;135: 1130-1141
40. Sandborn WJ, Gasink C, Gao LL, et al. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012;367:1519-1528
41. Sandborn W, Gasink C, Blank M, et al. O-001 A Multicenter, doubleblind, placebo-controlled phase 3 study of ustekinumab, a human IL-12/ 23P40 mAB, in moderate-service Crohn's disease refractory to anti-TFNa: UNITI-1. Inflamm Bowel Dis. 2016;22(suppl 1):S1
42. Feagan BGC, Lang Y, Friedman JR, et al. A multicenter, double-blind, placebo-controlled PH3 study of ustekinumab, a human monoclonal antibody to IL-12/23P40, in patients with moderately-severely active Crohn's disease who are naive or not refractory to anti-TNFA: UNITI-2. Eur Gastroenterol J. 2015;3:563
43. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003; 348:601-608
44. Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. 1998;41:1552-1563
45. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002;359: 1541-1549
46. Khanna R, Sattin BD, Afif W, et al. Review article: a clinician's guide for therapeutic drug monitoring of infliximab in inflammatory bowel disease. Aliment Pharmacol Ther. 2013;38:447-459
47. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010;362: 1383-1395
48. Akobeng AK, Zachos M. Tumor necrosis factor-alpha antibody for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2004; 1:CD003574
49. Feagan BG, McDonald JW, Panaccione R, et al. Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease. Gastroenterology. 2014;146:681-688. e1
50. Panaccione R, Ghosh S, Middleton S, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology. 2014;146:392-400. e3
51. Farrell RJ, Alsahli M, Jeen YT, et al. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology. 2003;124:917-924
52. Hanauer SB, Wagner CL, Bala M, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol. 2004;2:542-553
53. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007;357:228-238
54. Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial. Gut. 2007;56:1232-1239
55. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007;357:239-250
56. Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology. 2009;137:1628-1640
57. Ordas I, Mould DR, Feagan BG, et al. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther. 2012;91:635-646
58. Rosario M, Wyant T, Milch C, et al. Pharmacokinetic and pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: additional results from the GEMINI 1 and 2 studies. J Crohn's Colitis. 2014;8:S42-S43