Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: A phase II randomised study

Gut

Volumn 63, Issue 3, 2014, Pages 442-450

  Mayer, Lloyd ^a   Sandborn, William J ^b   Stepanov, Yuriy ^c   Geboes, Karel ^d   Hardi, Robert ^e   Yellin, Michael ^f   Tao, Xiaolu ^g   Xu, Li An ^g   Salter Cid, Luisa ^g   Gujrathi, Sheila ^g   Aranda, Richard ^g   Luo, Allison Y ^g  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Dnipropetrovsk State Medical Academy   (Ukraine)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^e Chevy Chase Clinical Research   (United States)

^f MEDAREX INC   (United States)

^g BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY TARGETED THERAPY; ULCERATIVE COLITIS;

ADMINISTRATION, INTRAVENOUS; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL; CHEMOKINE CXCL10; COLITIS, ULCERATIVE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INDUCTION CHEMOTHERAPY; INTENTION TO TREAT ANALYSIS; LOGISTIC MODELS; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84893725774     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2012-303424     Document Type: Article

References (29)

1. Ordas I, Eckmann L, Talimini M, et al. Ulcerative colitis. Lancet 2012;380:1606-19.
2. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010;105:501-23; quiz 24.
3. Travis SP, Stange EF, Lemann M, et al. European evidence-based Consensus on the management of ulcerative colitis: current management. J Crohns Colitis 2008;2:24-62. (Pubitemid 351179488)
4. Lichtenstein GR, Abreu MT, Cohen R, et al. American Gastroenterological Association Institute technical review on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology 2006;130:940-87. (Pubitemid 43374543)
5. Kuhne MPB, Wallace S, Chen S, et al. MDX-1100, a fully human anti-CXCL 10 (IP-10) antibody, is a high affinity, neutralizing antibody that has rntered phase I clinical trials for the treatment of Ulcerative Colitis (UC). J Immunol 2007;178:20.
6. Kabashima H, Yoneda M, Nagata K, et al. The presence of chemokine (MCP-1, MIP-1(alpha), MIP-1(beta), IP-10, RANTES)-positive cells and chemokine receptor (CCR5, CXCR3)-positive cells in inflamed human gingival tissues. Cytokine 2002;20:70-7. (Pubitemid 35373723)
7. Molesworth-Kenyon S, Mates A, Yin R, et al. CXCR3, IP-10, and Mig are required for CD4+ T cell recruitment during the DTH response to HSV-1 yet are independent of the mechanism for viral clearance. Virology 2005;333:1-9. (Pubitemid 40222186)
8. Romagnani P, Maggi L, Mazzinghi B, et al. CXCR3-mediated opposite effects of CXCL10 and CXCL4 on TH1 or TH2 cytokine production. J Allergy Clin Immunol 2005;116:1372-9. (Pubitemid 41740951)
9. Suzuki K, Kawauchi Y, Palaniyandi SS, et al. Blockade of interferon-gammainducible protein-10 attenuates chronic experimental colitis by blocking cellular trafficking and protecting intestinal epithelial cells. Pathol Int 2007;57: 413-20. (Pubitemid 46976408)
10. Soejima K, Rollins BJ. A functional IFN-gamma-inducible protein-10/CXCL10-specific receptor expressed by epithelial and endothelial cells that is neither CXCR3 nor glycosaminoglycan. J Immunol 2001;167:6576-82. (Pubitemid 33081594)
11. Schulthess FT, Paroni F, Sauter NS, et al. CXCL10 impairs beta cell function and viability in diabetes through TLR4 signaling. Cell Metab 2009;9:125-39.
12. Luster AD, Greenberg SM, Leder P. The IP-10 chemokine binds to a specific cell surface heparan sulfate site shared with platelet factor 4 and inhibits endothelial cell proliferation. J Exp Med 1995;182:219-31.
13. 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. (Pubitemid 29370382)
14. Witte A, Kuhne MR, Preston BT, et al. W1170 CXCL10 expression and biological activities in inflammatory bowel disease. Gastroenterology 2008;134:A-648.
15. 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. (Pubitemid 35414877)
16. Singh UP, Singh S, Taub DD, et al. Inhibition of IFN-gamma-inducible protein-10 abrogates colitis in IL-10-/- mice. J Immunol 2003;171:1401-6. (Pubitemid 36900073)
17. 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. (Pubitemid 41368267)
18. Mayer L, Sandborn WJ, Stepanov Y, et al. A randomized placebo-controlled trial of MDX-1100, an anti-IP-10 antibody, for moderately-to-severely active ulcerative colitis. Oral presentation at DDW (Abstract 711a) 2010.
19. Hardi R, Mayer L, Targan SR, et al. A phase 1 open-label, single-dose, dose-escalation study of MDX-1100, a high-affinity, neutralizing, fully human Igg1 (kappa) anti-CXCL10 (Ip10) monoclonal antibody, in ulcerative colitis. Gastroenterology 2008;134:A-99-100.
20. Yellin M, Paliienko I, Balanescu A, et al. A phase II, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of MDX-1100, a fully human anti-CXCL10 monoclonal antibody, in combination with methotrexate in patients with rheumatoid arthritis. Arthritis Rheum 2011;64:1730-9.
21. D'Haens G, Sandborn WJ, Feagan BG, et al. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology 2007;132:763-86.
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. (Pubitemid 18010466)
23. Geboes K, Riddell R, Ost A, et al. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut 2000;47:404-9.
24. Geboes K, Olson A, Marano C. Infliximab results in reduction of inflammation and inflammatory markers in the mucosa of ulcerative colitis patients: the ACT 1 trial (Abstract). Am J Gastroenterol 2005;100:S292-3.
25. Yellin M, Paliienko I, Balanescu A, et al. A phase 2, multi-dose, double-blind, placebo-controlled, randomized, multicenter study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in combination with methotrexate in patients with active rheumatoid arthritis. Arthritis Rheum 2009;60:414.
26. Afif W, Leighton JA, Hanauer SB, et al. Open-label study of adalimumab in patients with ulcerative colitis including those with prior loss of response or intolerance to infliximab. Inflamm Bowel Dis 2009;15:1302-7.
27. Baumgart DC, Targan SR, Dignass AU, et al. Prospective randomized open-label multicenter phase I/II dose escalation trial of visilizumab (HuM291) in severe steroid-refractory ulcerative colitis. Inflamm Bowel Dis 2010;16:620-9.
28. 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. (Pubitemid 41770166)
29. Sandborn W, Colombel J-F, Hanauer S, et al. A randomized placebo-controlled trial of abatacept for moderately-to-severely active ulcerative colitis. DDW abstract 2010.