Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists

Clinical Gastroenterology and Hepatology

Volumn 15, Issue 2, 2017, Pages 229-239.e5

  Feagan, Brian G ^a   Rubin, David T ^b   Danese, Silvio ^c   Vermeire, Severine ^d   Abhyankar, Brihad ^e   Sankoh, Serap ^f   James, Alexandra ^e   Smyth, Michael ^e  

^a ROBARTS RESEARCH INSTITUTE   (Canada)

^b UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^c HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^e Takeda Global Research and Development Centre Europe   (United Kingdom)

^f TAKEDA PHARMACEUTICAL COMPANY LIMITED   (Japan)

Author keywords

Biologic Naive; GEMINI; Inflammatory Bowel Disease; Treatment Failure

Indexed keywords

PLACEBO; TUMOR NECROSIS FACTOR ANTIBODY; VEDOLIZUMAB; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY;

ARTICLE; DRUG EFFECT; DRUG EFFICACY; DRUG EXPOSURE; DRUG RESPONSE; DRUG TREATMENT FAILURE; HUMAN; MAINTENANCE THERAPY; MULTICENTER STUDY (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; TREATMENT OUTCOME; ULCERATIVE COLITIS; ADULT; COLITIS, ULCERATIVE; FEMALE; INDUCTION CHEMOTHERAPY; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; PROCEDURES;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; CLINICAL TRIALS, PHASE III AS TOPIC; COLITIS, ULCERATIVE; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INDUCTION CHEMOTHERAPY; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 85009431279     PISSN: 15423565     EISSN: 15427714     Source Type: Journal    
DOI: 10.1016/j.cgh.2016.08.044     Document Type: Article

References (38)

1. 1 Danese, S., Fiocchi, C., Ulcerative colitis. N Engl J Med 365 (2011), 1713–1725.
2. 2 Rutgeerts, P., Sandborn, W.J., Feagan, B.G., et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 353 (2005), 2462–2476.
3. 3 Sandborn, W.J., van Assche, G., Reinisch, W., et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 142 (2012), 257–265.
4. 4 Sandborn, W.J., Feagan, B.G., Marano, C., et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 146 (2014), 85–95.
5. 5 Sandborn, W.J., Feagan, B.G., Marano, C., et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology 146 (2014), 96–109.
6. 6 Ford, A.C., Peyrin-Biroulet, L., Opportunistic infections with anti-tumor necrosis factor-alpha therapy in inflammatory bowel disease: meta-analysis of randomized controlled trials. Am J Gastroenterol 108 (2013), 1268–1276.
7. 7 Lichtenstein, G.R., Rutgeerts, P., Sandborn, W.J., et al. A pooled analysis of infections, malignancy, and mortality in infliximab- and immunomodulator-treated adult patients with inflammatory bowel disease. Am J Gastroenterol 107 (2012), 1051–1063.
8. 8 Soler, D., Chapman, T., Yang, L.L., et al. The binding specificity and selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther 330 (2009), 864–875.
9. 9 Wyant, T., Estevam, J., Yang, L., et al. Development and validation of receptor occupancy pharmacodynamic assays used in the clinical development of the monoclonal antibody vedolizumab. Cytometry B Clin Cytom 90 (2016), 168–176.
10. 10 Fedyk, E.R., Wyant, T., Yang, L.L., et al. Exclusive antagonism of the α4β7 integrin by vedolizumab confirms the gut-selectivity of this pathway in primates. Inflamm Bowel Dis 18 (2012), 2107–2119.
11. 11 Haanstra, K.G., Hofman, S.O., Lopes Estevao, D.M., et al. Antagonizing the α4β7 integrin, but not α4β7, inhibits leukocytic infiltration of the central nervous system in rhesus monkey experimental autoimmune encephalomyelitis. J Immunol 190 (2013), 1961–1973.
12. 12 Hesterberg, P.E., Winsor-Hines, D., Briskin, M.J., et al. Rapid resolution of chronic colitis in the cotton-top tamarin with an antibody to a gut-homing integrin α4β7. Gastroenterology 111 (1996), 1373–1380.
13. 13 Milch, C., Wyant, T., Xu, J., et al. Vedolizumab, a monoclonal antibody to the gut homing α4β7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype. J Neuroimmunol 264 (2013), 123–126.
14. 14 Takeda, Entyvio (vedolizumab). [package insert], 2014, Takeda Pharmaceuticals America, Inc., Deerfield, IL.
15. 15 Feagan, B.G., Rutgeerts, P., Sands, B.E., et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 369 (2013), 699–710.
16. 16 du Prel, J.B., Hommel, G., Rohrig, B., et al. Confidence interval or p-value? Part 4 of a series on evaluation of scientific publications. Dtsch Arztebl Int 106 (2009), 335–339.
17. 17 Brown, E.G., Wood, L., Wood, S., The medical dictionary for regulatory activities (MedDRA). Drug Saf 20 (1999), 109–117.
18. 18 Colombel, J.F., Sands, B.E., Rutgeerts, P., et al. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut, 2016 [Epub ahead of print].
19. 19 Pola, S., Patel, D., Ramamoorthy, S., et al. Strategies for the care of adults hospitalized for active ulcerative colitis. Clin Gastroenterol Hepatol 10 (2012), 1315–1325 e4.
20. 20 Sandborn, W.J., Rutgeerts, P., Enns, R., et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 146 (2007), 829–838.
21. 21 de Silva, P.S., Nguyen, D.D., Sauk, J., et al. Long-term outcome of a third anti-TNF monoclonal antibody after the failure of two prior anti-TNFs in inflammatory bowel disease. Aliment Pharmacol Ther 36 (2012), 459–466.
22. 22 Rubin, D.T., Mody, R., Davis, K.L., et al. Real-world assessment of therapy changes, suboptimal treatment and associated costs in patients with ulcerative colitis or Crohn's disease. Aliment Pharmacol Ther 39 (2014), 1143–1155.
23. 23 Yanai, H., Hanauer, S.B., Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol 106 (2011), 685–698.
24. 24 Moss, A.C., Optimizing the use of biological therapy in patients with inflammatory bowel disease. Gastroenterol Rep (Oxf) 3 (2015), 63–68.
25. 25 Colombel, J.F., Feagan, B.G., Sandborn, W.J., et al. Therapeutic drug monitoring of biologics for inflammatory bowel disease. Inflamm Bowel Dis 18 (2012), 349–358.
26. 26 Afif, W., Loftus, E.V. Jr., Faubion, W.A., et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol 105 (2010), 1133–1139.
27. 27 Rosario, M., Fox, I., Milch, C., et al. Pharmacokinetic/pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: additional results from GEMINI 1 and 2 [abstract]. Inflamm Bowel Dis, 19(Suppl 1), 2013, 140.
28. 28 Colombel, J.F., Sandborn, W.J., Reinisch, W., et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 362 (2010), 1383–1395.
29. 29 Subramaniam, K., Richardson, A., Dodd, J., et al. Early predictors of colectomy and long-term maintenance of remission in ulcerative colitis patients treated using anti-tumour necrosis factor therapy. Intern Med J 44 (2014), 464–470.
30. 30 Garcia-Bosch, O., Gisbert, J.P., Canas-Ventura, A., et al. Observational study on the efficacy of adalimumab for the treatment of ulcerative colitis and predictors of outcome. J Crohns Colitis 7 (2013), 717–722.
31. 31 Hayes, M.J., Stein, A.C., Sakuraba, A., Comparison of efficacy, pharmacokinetics, and immunogenicity between infliximab mono- versus combination therapy in ulcerative colitis. J Gastroenterol Hepatol 29 (2014), 1177–1185.
32. 32 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 146 (2014), 392–400 e3.
33. 33 Cross, R.K., Which patients with inflammatory bowel disease should receive combination therapy?. Expert Rev Gastroenterol Hepatol 9 (2015), 715–717.
34. 34 Orlando, A., Guglielmi, F.W., Cottone, M., et al. Clinical implications of mucosal healing in the management of patients with inflammatory bowel disease. Dig Liver Dis 45 (2013), 986–991.
35. 35 Vande Casteele, N., Ferrante, M., Van Assche, G., et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology 148 (2015), 1320–1329.
36. 36 Vande Casteele, N., Feagan, B.G., Gils, A., et al. Therapeutic drug monitoring in inflammatory bowel disease: current state and future perspectives. Curr Gastroenterol Rep, 16, 2014, 378.
37. 37 D'Haens, G.R., Panaccione, R., Higgins, P.D., et al. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organization: when to start, when to stop, which drug to choose, and how to predict response?. Am J Gastroenterol 106 (2011), 199–212 quiz 3.
38. 38 Ben-Horin, S., Kopylov, U., Chowers, Y., Optimizing anti-TNF treatments in inflammatory bowel disease. Autoimmun Rev 13 (2014), 24–30.