Etrolizumab as induction therapy for ulcerative colitis: A randomised, controlled, phase 2 trial

The Lancet

Volumn 384, Issue 9940, 2014, Pages 309-318

  Vermeire, Séverine ^a   O'Byrne, Sharon ^b   Keir, Mary ^b   Williams, Marna ^b   Lu, Timothy T ^b   Mansfield, John C ^d   Lamb, Christopher A ^d   Feagan, Brian G ^e   Panes, Julian ^g   Salas, Azucena ^g   Baumgart, Daniel C ^h   Schreiber, Stefan ⁱ   Dotan, Iris ^j,k   Sandborn, William J ^c   Tew, Gaik W ^b   Luca, Diana ^b   Tang, Meina T ^b   Diehl, Lauri ^b   Eastham Anderson, Jeffrey ^b   De Hertogh, Gert ^a   Perrier, Clementine ^a   Egen, Jackson G ^b   Kirby, John A ^d   Van Assche, Gert ^a,f   Rutgeerts, Paul ^a   more..

^a UNIVERSITY OF LEUVEN   (Belgium)

^b GENENTECH INC   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d NEWCASTLE UNIVERSITY   (United Kingdom)

^e UNIVERSITY OF WESTERN ONTARIO   (Canada)

^f UNIVERSITY OF TORONTO   (Canada)

^g HOSPITAL CLÍNIC   (Spain)

^h HUMBOLDT UNIVERSITY   (Germany)

ⁱ UNIVERSITY OF KIEL   (Germany)

^j TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

^k TEL AVIV UNIVERSITY   (Israel)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; ETROLIZUMAB; MERCAPTOPURINE; MESALAZINE; METHOTREXATE; PLACEBO; PREDNISONE; CORTICOSTEROID; IMMUNOSUPPRESSIVE AGENT;

ADULT; AGED; ARTHRALGIA; ARTICLE; ASTHENIA; CONTROLLED STUDY; COUGHING; DISEASE ACTIVITY; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ENDOSCOPY; FATIGUE; FEMALE; FLU LIKE SYNDROME; HEADACHE; HUMAN; INJECTION SITE REACTION; IRON DEFICIENCY ANEMIA; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUROLOGIC DISEASE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; REMISSION; RHINOPHARYNGITIS; TREATMENT OUTCOME; TREATMENT RESPONSE; ULCERATIVE COLITIS; CORTICOSTEROID THERAPY; DRUG ERUPTION; DRUG INDUCED HEADACHE; HEALTH CARE FACILITY; IMMUNOMODULATION; INTENTION TO TREAT ANALYSIS; MAYO CLINIC SCORE; SCORING SYSTEM;

ADULT; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; COLITIS, ULCERATIVE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; REMISSION INDUCTION; TIME FACTORS; TREATMENT OUTCOME;

EID: 84904857048     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)60661-9     Document Type: Article

References (29)

1. Kaser A, Zeissig S, Blumberg RS. Inflammatory bowel disease. Annu Rev Immunol 2010; 28: 573-621 .
2. 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 .
3. Beaugerie L, Brousse N, Bouvier AM, et al, for the CESAME Study Group. Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: A prospective observational cohort study. Lancet 2009; 374: 1617-25 .
4. Feagan BG, Greenberg GR, Wild G, et al. Treatment of ulcerative colitis with a humanized antibody to the α4β7 integrin. N Engl J Med 2005; 352: 2499-507 .
5. 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: 1068-75 .
6. Feagan BG, Rutgeerts P, Sands BE, et al, for the GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013; 369: 699-710 .
7. Holzmann B, McIntyre BW, Weissman IL. Identification of a murine Peyer's patch-specifi c lymphocyte homing receptor as an integrin molecule with an α chain homologous to human VLA-4α. Cell 1989; 56: 37-46 .
8. Hu MC, Crowe DT, Weissman IL, Holzmann B. Cloning and expression of mouse integrin βp(β7): A functional role in Peyer's patch-specific lymphocyte homing. Proc Natl Acad Sci USA 1992; 89: 8254-58 .
9. Cepek KL, Parker CM, Madara JL, Brenner MB. Integrin alpha E beta 7 mediates adhesion of T lymphocytes to epithelial cells. J Immunol 1993; 150: 3459-70.
10. Karecla PI, Bowden SJ, Green SJ, Kilshaw PJ. Recognition of E-cadherin on epithelial cells by the mucosal T cell integrin αM290β7 (αEβ7). Eur J Immunol 1995; 25: 852-56 .
11. Schon MP, Arya A, Murphy EA, et al. Mucosal T lymphocyte numbers are selectively reduced in integrin αE (CD103)-defi cient mice. J Immunol 1999; 162: 6641-49 .
12. 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: 1625-29 .
13. Geboes K, Riddell R, Ost A, Jensfelt B, Persson T, Lofberg R. A reproducible grading scale for histological assessment of infl ammation in ulcerative colitis. Gut 2000; 47: 404-09 .
14. Wei X, Wang Y, Fuh F, et al. Pharmacokinetic and pharmacodynamic modeling of the relationship between serum rhumab β7 levels and β7 receptor occupancy in phase I patients with ulcerative colitis [abstract PII-74]. Clin Pharmacol Ther 2012; 91 (suppl 1): S80 .
15. Miyara M, Yoshioka Y, Kitoh A, et al. Functional delineation and differentiation dynamics of human CD4+ T cells expressing the FoxP3 transcription factor. Immunity 2009; 30: 899-911 .
16. Arijs I, De Hertogh G, Machiels K, et al. Mucosal gene expression of cell adhesion molecules, chemokines, and chemokine receptors in patients with infl ammatory bowel disease before and after infliximab treatment. Am J Gastroenterol 2011; 106: 748-61 .
17. Thomas S, Baumgart DC. Targeting leukocyte migration and adhesion in Crohn's disease and ulcerative colitis. Inflammopharmacology 2012; 20: 1-18 .
18. Iliev ID, Spadoni I, Mileti E, et al. Human intestinal epithelial cells promote the diff erentiation of tolerogenic dendritic cells. Gut 2009; 58: 1481-89 .
19. Jaensson E, Uronen-Hansson H, Pabst O, et al. Small intestinal CD103+ dendritic cells display unique functional properties that are conserved between mice and humans. J Exp Med 2008; 205: 2139-49 .
20. Siddiqui KRR, Powrie F. CD103+ GALT DCs promote Foxp3+ regulatory T cells. Mucosal Immunol 2008; 1 (suppl 1): 34-38 .
21. Annacker O, Coombes JL, Malmstrom V, et al. Essential role for CD103 in the T cell-mediated regulation of experimental colitis. J Exp Med 2005; 202: 1051-61 .
22. Banz A, Peixoto A, Pontoux C, Cordier C, Rocha B, Papiernik M. A unique subpopulation of CD4+ regulatory T cells controls wasting disease, IL-10 secretion and T cell homeostasis. Eur J Immunol 2003; 33: 2419-28 .
23. Lehmann J, Huehn J, de la Rosa M, et al. Expression of the integrin αEβ7 identifi es unique subsets of CD25+ as well as CD25- regulatory T cells. Proc Natl Acad Sci USA 2002; 99: 13031-36 .
24. Suffia I, Reckling SK, Salay G, Belkaid Y. A role for CD103 in the retention of CD4+CD25+ Treg and control of Leishmania major infection. J Immunol 2005; 174: 5444-55 .
25. El-Asady R, Yuan R, Liu K, et al. TGF-β-dependent CD103 expression by CD8+ T cells promotes selective destruction of the host intestinal epithelium during graft-versus-host disease. J Exp Med 2005; 201: 1647-57 .
26. Fuchs A, Vermi W, Lee JS, et al. Intraepithelial type 1 innate lymphoid cells are a unique subset of IL-12- and IL-15-responsive IFN-γ-producing cells. Immunity 2013; 38: 769-81 .
27. Ludviksson BR, Strober W, Nishikomori R, Hasan SK, Ehrhardt RO. Administration of mAb against αEβ7 prevents and ameliorates immunization-induced colitis in IL-2-/- mice. J Immunol 1999; 162: 4975-82 .
28. Sathaliyawala T, Kubota M, Yudanin N, et al. Distribution and compartmentalization of human circulating and tissue-resident memory T cell subsets. Immunity 2013; 38: 187-97 .
29. Sheridan BS, Lefrancois L. Regional and mucosal memory T cells. Nat Immunol 2011; 12: 485-91.