Eldelumab [Anti-IP-10] induction therapy for ulcerative colitis: A randomised, placebo-controlled, phase 2b study

Journal of Crohn's and Colitis

Volumn 10, Issue 4, 2016, Pages 418-428

  Sandborn, William J ^a   Colombel, Jean Frédéric ^b   Ghosh, Subrata ^c   Sands, Bruce E ^b   Dryden, Gerald ^d   Hébuterne, Xavier ^e   Leong, Rupert W ^f   Bressler, Brian ^g   Ullman, Thomas ^b   Lakatos, Peter L ^h   Reinisch, Walter ^i,j   Xu, Li An ^k   Luo, Allison ^l  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF CALGARY   (Canada)

^d University of Louisville School of Medicine   (United States)

^e UNIVERSITÉ CÔTE D'AZUR   (France)

^f UNIVERSITY OF NEW SOUTH WALES   (Australia)

^g ST PAUL S HOSPITAL   (Canada)

^h SEMMELWEIS UNIVERSITY   (Hungary)

ⁱ MEDICAL UNIVERSITY OF VIENNA   (Austria)

^j MCMASTER UNIVERSITY   (Canada)

^k BRISTOL MYERS SQUIBB   (United States)

^l NONE

more..

Author keywords

Inflammatory bowel diseases; Ulcerative colitis

Indexed keywords

ANTIHISTAMINIC AGENT; CORTICOSTEROID; ELDELUMAB; PLACEBO; CXCL10 PROTEIN, HUMAN; GAMMA INTERFERON INDUCIBLE PROTEIN 10; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY;

ABNORMAL LABORATORY RESULT; ADULT; AGED; ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FEMALE; HEADACHE; HUMAN; HYPERSENSITIVITY; IMMUNOGENICITY; INFECTION; INFESTATION; INFUSION RELATED REACTION; MAJOR CLINICAL STUDY; MALE; MINIMUM PLASMA CONCENTRATION; NAUSEA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHINOPHARYNGITIS; TACHYCARDIA; TREATMENT OUTCOME; TREATMENT RESPONSE; ULCERATIVE COLITIS; URTICARIA; VERTIGO; VOMITING; ADOLESCENT; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; COLITIS, ULCERATIVE; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; CHEMOKINE CXCL10; COLITIS, ULCERATIVE; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; REMISSION INDUCTION; YOUNG ADULT;

EID: 84966378462     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1093/ecco-jcc/jjv224     Document Type: Article

References (32)

1. Ordas I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet 2012;380:1606-19.
2. Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology 2004;126:1504-17.
3. Molodecky NA, Soon IS, Rabi DM, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology 2012;142:46-54.
4. Torres J, Danese S, Colombel JF. New therapeutic avenues in ulcerative colitis: thinking out of the box. Gut 2013;62:1642-52.
5. Dudley-Brown S, Baker K. Ulcerative colitis from patients' viewpoint: a review of two internet surveys. Gastroenterol Nurs 2012;35:54-63.
6. Rubin DT, Siegel CA, Kane SV, et al. Impact of ulcerative colitis from patients' and physicians' perspectives: results from the UC: NORMAL survey. Inflamm Bowel Dis 2009;15:581-8.
7. Rubin DT, Dubinsky MC, Panaccione R, et al. The impact of ulcerative colitis on patients' lives compared to other chronic diseases: a patient survey. Dig Dis Sci 2010;55:1044-52.
8. Ford AC, Achkar JP, Khan KJ, et al. Efficacy of 5-aminosalicylates in ulcerative colitis: systematic review and meta-analysis. Am J Gastroenterol 2011;106:601-16.
9. Timmer A, McDonald JW, Tsoulis DJ, et al. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev 2012;9:CD000478.
10. Siegel CA, Sands BE. Review article: practical management of inflammatory bowel disease patients taking immunomodulators. Aliment Pharmacol Ther 2005;22:1-16.
11. Ferrante M, Vermeire S, Fidder H, et al. Long-term outcome after infliximab for refractory ulcerative colitis. J Crohns Colitis 2008;2:219-25.
12. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005;353:2462-76.
13. Yamada S, Yoshino T, Matsuura M, et al. Long-term efficacy of infliximab for refractory ulcerative colitis: results from a single center experience. BMC Gastroenterol 2014;14:80.
14. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001;345:1098-104.
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. Suzuki K, Kawauchi Y, Palaniyandi SS, et al. Blockade of interferon-ginducible protein-10 attenuates chronic experimental colitis by blocking cellular trafficking and protecting intestinal epithelial cells. Pathol Int 2007;57:413-20.
17. Uguccioni M, Gionchetti P, Robbiani DF, et al. Increased expression of IP-10, IL-8, MCP-1, and MCP-3 in ulcerative colitis. Am J Pathol 1999;155:331-6.
18. Hyun JG, Lee G, Brown JB, et al. Anti-interferon-inducible chemokine, CXCL10, reduces colitis by impairing T helper-1 induction and recruitment in mice. Inflamm Bowel Dis 2005;11:799-805.
19. Sasaki S, Yoneyama H, Suzuki K, et al. Blockade of CXCL10 protects mice from acute colitis and enhances crypt cell survival. Eur J Immunol 2002;32:3197-205.
20. Singh UP, Singh S, Taub DD, et al. Inhibition of IFN-g-inducible protein-10 abrogates colitis in IL-10-/-mice. J Immunol 2003;171:1401-6.
21. Mayer L, Sandborn WJ, Stepanov Y, et al. Anti-IP-10 antibody [BMS-936557] for ulcerative colitis: a phase II randomised study. Gut 2013;63:442-50.
22. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987;317:1625-9.
23. Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989;96:804-10.
24. Mitchell A, Guyatt G, Singer J, et al. Quality of life in patients with inflammatory bowel disease. J Clin Gastroenterol 1988;10:306-10.
25. Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007;132:52-65.
26. Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human anti-tumor necrosis factor monoclonal antibody [adalimumab] in Crohn's disease: the CLASSIC-I trial. Gastroenterology 2006;130:323-33.
27. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 2007;146:829-38.
28. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut 2011;60:780-7.
29. Sandborn WJ, Van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2012;142:257-65.e3.
30. Garud S, Brown A, Cheifetz A, et al. Meta-analysis of the placebo response in ulcerative colitis. Dig Dis Sci 2008;53:875-91.
31. Su C, Lewis JD, Goldberg B, et al. A meta-analysis of the placebo rates of remission and response in clinical trials of active ulcerative colitis. Gastroenterology 2007;132:516-26.
32. Vermeire S, O'Byrne S, Keir M, et al. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet 2014;384:309-18.