Inflammatory bowel disease therapies discontinued between 2009 and 2014

Expert Opinion on Investigational Drugs

Volumn 24, Issue 7, 2015, Pages 949-956

  Mozaffari, Shilan ^a   Nikfar, Shekoufeh ^a   Abdollahi, Mohammad ^a  

^a TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

Author keywords

Crohn's disease; Discontinued treatment; Inflammatory bowel disease; Ulcerative colitis

Indexed keywords

ABATACEPT; ALKALINE PHOSPHATASE; BLOOD CLOTTING FACTOR 13; BRODALUMAB; CATRIDECACOG; CNDO 201; DACLIZUMAB; ELUBRIXIN; GAMMA INTERFERON; GASTROINTESTINAL AGENT; INTERLEUKIN 12; INTERLEUKIN 17; INTERLEUKIN 18; INTERLEUKIN 2; INTERLEUKIN 23; INTERLEUKIN 25; INTERLEUKIN 5; LOW MOLECULAR WEIGHT HEPARIN; NU 206; PLACEBO; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG; VATELIZUMAB; ANTIINFLAMMATORY AGENT;

ANTIINFLAMMATORY ACTIVITY; CROHN DISEASE; DISEASE EXACERBATION; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; FEVER; HUMAN; MAINTENANCE THERAPY; NONHUMAN; PATHOPHYSIOLOGY; REMISSION; REVIEW; RHINOPHARYNGITIS; SINGLE DRUG DOSE; TREATMENT FAILURE; ULCERATIVE COLITIS; ANIMAL; COLITIS, ULCERATIVE;

ANIMALS; ANTI-INFLAMMATORY AGENTS; COLITIS, ULCERATIVE; CROHN DISEASE; HUMANS;

EID: 84934947419     PISSN: 13543784     EISSN: 17447658     Source Type: Journal    
DOI: 10.1517/13543784.2015.1035432     Document Type: Review

References (62)

1. Walsh A, Mabee J, Trivedi K. Inflammatory bowel disease. Prim Care 2011;38:415-32
2. Nikfar S, Rahimi R, Rezaie A, et al. A meta-analysis of the efficacy of sulfasalazine in comparison with 5-aminosalicylates in the induction of improvement and maintenance of remission in patients with ulcerative colitis. Dig Dis Sci 2009;54:1157-70
3. Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol 2011;106:590-9
4. Rahimi R, Nikfar S, Abdollahi M. Do anti-tumor necrosis factors induce response and remission in patients with acute refractory Crohn's disease? A systematic meta-analysis of controlled clinical trials. Biomed Pharmacother 2007;61:75-80
5. Nikfar S, Mirfazaelian H, Abdollahi M. Efficacy and tolerability of immunoregulators and antibiotics infistulizing Crohn's disease: a systematic review and meta-analysis of placebo controlled trials. Curr Pharm Des 2010;16:3684-98
6. Rahimi R, Nikfar S, Rezaie A, et al. A meta-analysis of antibiotic therapy for active ulcerative colitis. Dig Dis Sci 2007;52:2920-5
7. Rahimi R, Nikfar S, Rezaie A, et al. A meta-analysis of broad-spectrum antibiotic therapy in patients with active Crohn's disease. Clin Ther 2006;28:1983-8
8. Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev 2008(1):CD006893
9. Lawson MM, Thomas AG, Akobeng AK. Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database Syst Rev 2006(3):CD005112
10. Bernstein CN, Fried M, Krabshuis JH, et al. World Gastroenterology Organization Practice Guidelines for the diagnosis and management of IBD in 2010. Inflamm Bowel Dis 2010;16:112-24
11. Rezaie A, Parker RD, Abdollahi M. Oxidative stress and pathogenesis of inflammatory bowel disease: an epiphenomenon or the cause? Dig Dis Sci 2007;52:2015-21
12. Mozaffari S, Nikfar S, Abdolghaffari AH, et al. New biologic therapeutics for ulcerative colitis and Crohn's disease. Expert Opin Biol Ther 2014;14:583-600
13. Kawalec P, Mikrut A, Lopuch S. Systematic review of the effectiveness of biological therapy for active moderate to severe ulcerative colitis. J Gastroenterol Hepatol 2014;29:1159-70
14. Fitzpatrick LR. Inhibition of IL-17 as a pharmacological approach for IBD. Int Rev Immunol 2013;32:544-55
15. Fitzpatrick LR. Novel pharmacological approaches for inflammatory bowel disease: targeting key intracellular pathways and the IL-23/IL-17 axis. Int J Inflam 2012;2012:38940
16. Endres CJ, Salinger DH, Köck K, et al. Population pharmacokinetics of brodalumab in healthy adults and adults with psoriasis from single and multiple dose studies. J Clin Pharmacol 2014;54:1230-8
17. Coimbra S, Figueiredo A, Santos-Silva A. Brodalumab: an evidence-based review of its potential in the treatment of moderate-to-severe psoriasis. Core Evid 2014;9:89-97
18. Amgen. AMG 827 in Subjects With Moderate to Severe Crohn's Disease. 2011. Available from: http://clinicaltrials. gov/ct2/show/NCT01150890
19. Amgen. Safety Study in Subjects With Crohn's Disease. 2011. Available from: http://clinicaltrials.gov/ct2/show/NCT01199302
20. Pescovitz MD. Daclizumab: humanized monoclonal antibody to the interleukin-2 receptor. Expert Rev Clin Immunol 2005;1:337-44
21. Biogen Idec. Daclizumab Japanese PK Study. 2013. Available from: http://clinicaltrials.gov/ct2/show//NCT01929746
22. Van Assche G, Dalle I, Noman M, et al. A pilot study on the use of the humanized anti-interleukin-2 receptor antibody daclizumab in active ulcerative colitis. Am J Gastroenterol 2003;98:369-76
23. Van Assche G, Sandborn WJ, Feagan BG, et al. Daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor (CD25), for the treatment of moderately to severely active ulcerative colitis: a randomised, double blind, placebo controlled, dose ranging trial. Gut 2006;55:1568-74
24. GlaxoSmithKline. Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis. 2009. Available from: http://clinicaltrials. gov/ct2/show/NCT00748410
25. GlaxoSmithKline. Repeat Dose Study in Male Healthy Volunteer Smokers. 2008. Available from: http://clinicaltrials. gov/ct2/show/NCT00615576
26. GlaxoSmithKline. Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone. 2007. Available from: http://clinicaltrials. gov/ct2/show/NCT00551811
27. GlaxoSmithKline. A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects. 2007. Available from: http://clinicaltrials. gov/ct2/show/NCT00504439
28. Press release, Chromos, 2 Feb 2006
29. Sanofi. Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis. 2007. Available from: http://clinicaltrials. gov/ct2/show/NCT01659138
30. Sanofi. Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC). 2013. Available from: http://clinicaltrials. gov/ct2/show/NCT01861249
31. Podolsky DK. Beyond tumor necrosis factor: next-generation biologic therapy for inflammatory bowel disease. Dig Dis 2009;27:366-9
32. Sandborn WJ, Colombel JF, Sands BE, et al. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology 2012;143:62-9
33. Kaser A. Not all monoclonals are created equal-lessons from failed drug trials in Crohn's disease. Best Pract Res Clin Gastroenterol 2014;28:437-49
34. Garg SK, Croft AM, Bager P. Helminth therapy (worms) for induction of remission in inflammatory bowel disease. Cochrane Database Syst Rev 2014(1):CD009400
35. Sandborn WJ, Elliott DE, Weinstock J, et al. Randomised clinical trial: the safety and tolerability of Trichuris suis ova in patients with Crohn's disease. Aliment Pharmacol Ther 2013;38:255-63
36. Summers RW, Elliott DE, Urban JF Jr, et al. Trichuris suis therapy for active ulcerative colitis: a randomized controlled trial. Gastroenterology 2005;128:825-32
37. Summers RW, Elliott DE, Urban JF Jr, et al. Trichuris suis therapy in Crohn's disease. Gut 2005;54:87-90
38. Summers RW, Elliott DE, Qadir K, et al. Trichuris suis seems to be safe and possibly effective in the treatment of inflammatory bowel disease. Am J Gastroenterol 2003;98:2034-41
39. Fiasse R, Latinne D. Intestinal helminths: a clue explaining the low incidence of inflammatory bowel diseases in Subsaharan Africa? Potential benefits and hazards of helminth therapy. Acta Gastroenterol Belg 2006;69:418-22
40. Bregenzer N, Caesar I, Andus T, et al. Lack of clinical efficacy of additional factor XIII treatment in patients with steroid refractory colitis. The Factor XIII Study Group. Z Gastroenterol 1999;37:999-1004
41. Cario E, Goebell H, Dignass AU. Factor XIII modulates intestinal epithelial wound healing in vitro. Scand J Gastroenterol 1999;34:485-90
42. D'Argenio G, Grossman A, Cosenza V, et al. Recombinant factor XIII improves established experimental colitis in rats. Dig Dis Sci 2000;45:987-97
43. Lorenz R, Olbert P, Born P. Factor XIII in chronic inflammatory bowel diseases. Semin Thromb Hemost 1996;22:451-5
44. Novo Nordisk A/S. Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers. 2013. Available from: http://clinicaltrials.gov/ct2/show/NCT01848002
45. Novo Nordisk A/S. Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers. 2013. Available from: http://clinicaltrials. gov/ct2/show/NCT01847989
46. Novo Nordisk A/S. Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers. 2010. Available from: http://clinicaltrials. gov/ct2/show/NCT01153997
47. Novo Nordisk A/S. Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects. 2010. Available from: http://clinicaltrials. gov/ct2/show/NCT01082406
48. Novo Nordisk A/S. A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis. 2012. Available from: http://clinicaltrials. gov/ct2/show/NCT01706159
49. Zhao J, de Vera J, Narushima S, et al. R-spondin1, A Novel Intestinotrophic Mitogen, Ameliorates Experimental Colitis in Mice. Gastroenterology 2007;132:1331-43
50. Press releases, Nuvelo, 10 Dec 2008 & KHK, 28 Apr 2009
51. Form 10-Q, Nuvelo, 8 Nov 2006; Press releases, Nuvelo, 17 Mar & 23 Jul 2008
52. Sánchez de Medina F, Martínez-Augustin O, González R, et al. Induction of alkaline phosphatase in the inflamed intestine: a novel pharmacological target for inflammatory bowel disease. Biochem Pharmacol 2004;68:2317-26
53. Tuin A, Poelstra K, de Jager-Krikken A, et al. Role of alkaline phosphatase in colitis in man and rats. Gut 2009;58:379-87
54. Press releases, AM-Pharma, 4 Feb & 8 May 2003
55. Press release, AM-Pharma, 9 Jul 2007; 17th BioPartnerEur (London), 2009
56. Schölmerich J. Trichuris suis ova in inflammatory bowel disease. Dig Dis 2013;31:391-5
57. Kradin RL, Badizadegan K, Auluck P, et al. Iatrogenic Trichuris suis infection in a patient with Crohn disease. Arch Pathol Lab Med 2006;130:718-20
58. Seitz R, Leugner F, Katschinski M, et al. Ulcerative colitis and Crohn's disease: factor XIII, inflammation and haemostasis. Digestion 1994;55:361-7
59. Stadnicki A. Involvement of coagulation and hemostasis in inflammatory bowel diseases. Curr Vasc Pharmacol 2012;10:659-69
60. Folwaczny C. [Coagulation system and inflammatory bowel disease: therapeutic and pathophysiologic implications]. Z Gastroenterol 2002;40:991-8
61. Molnár K, Vannay A, Szebeni B, et al. Intestinal alkaline phosphatase in the colonic mucosa of children with inflammatory bowel disease. World J Gastroenterol 2012;18:3254-9
62. Danese S, Angelucci E, Malesci A, et al. Biological agents for ulcerative colitis: hypes and hopes. Med Res Rev 2008;28:201-18