Patient considerations in the management of ulcerative colitis - role of vedolizumab

Megha Kothari, Prashant Mudireddy, Arun Swaminath, Megha Kothari, Prashant Mudireddy, Arun Swaminath

Abstract

Ulcerative colitis (UC) is a subtype of inflammatory bowel disease which causes inflammation of the large intestine and affects approximately 7.6-24.6 per 100,000 persons. The therapeutic goal for UC patients is inducing remission, maintaining remission, and ideally, obtaining mucosal healing. Vedolizumab, approved by the US Food and Drug Administration in May 2014 for the treatment of moderate-to-severe UC and Crohn's disease, is a newly developed anti-integrin therapy. This review focuses on the preclinical development of vedolizumab and data from early trials, and details the results of the landmark trails that led to its approval in the USA with a specific focus on the management of UC. Additionally, data on safety and the current UC management protocols are also discussed.

Keywords: immunomodulator drugs; inflammation; infliximab; mucosal healing; remission; ulcerative colitis.

References

    1. Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011;365(18):1713–1725.
    1. Sands BE, Feagan BG, Rutgeerts P, et al. Effects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014;147(3):618e3–627e3.
    1. Gilroy L, Allen PB. Is there a role for vedolizumab in the treatment of ulcerative colitis and Crohn’s disease? Clin Exp Gastroenterol. 2014;7:163–172.
    1. 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(12):829–838.
    1. Deleporte A, Viennot S, Dupont B, et al. Efficacy of anti-TNF-alpha monoclonal antibodies in inflammatory bowel disease treatment. Int J Infereron Cytokine Mediator Res. 2013;2013(5):11–31.
    1. Rosario M, Dirks NL, Gastonguay MR, et al. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn’s disease. Aliment Pharmacol Ther. 2015;42(2):188–202.
    1. Feagan BG, Rutgeerts P, Sands BE, et al. GEMINI 1 Study Group Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699–710.
    1. Raine T. Vedolizumab for inflammatory bowel disease: changing the game, or more of the same? United European Gastroenterol J. 2014;2(5):333–344.
    1. Bressler B, Marshall JK, Bernstein CN, et al. Toronto Ulcerative Colitis Consensus Group Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the toronto consensus. Gastroenterology. 2015;148(5):1035e3–1058e3.
    1. Danese S, Panes J. Development of drugs to target interactions between leukocytes and endothelial cells and treatment algorithms for inflammatory bowel diseases. Gastroenterology. 2014;147(5):981–989.
    1. Soler D, Chapman T, Yang LL, Wyant T, Egan R, Fedyk ER. The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330(3):864–875.
    1. Milch C, Wyant T, Xu J, et al. Vedolizumab, a monoclonal antibody to the gut homing alpha4beta7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype. J Neuroimmunol. 2013;264(1–2):123–126.
    1. Wyant T, Leach T, Sankoh S, et al. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut. 2015;64(1):77–83.
    1. Feagan BG, Feagan BG, McDonald JWD, et al. An ascending dose trial of a humanized A4B7 antibody in ulcerative colitis (UC) Gastroenterology. 2000;118(4):A874.
    1. Feagan BG, Greenberg GR, Wild G, et al. Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin. N Engl J Med. 2005;352(24):2499–2507.
    1. Parikh A, Leach T, Wyant T, et al. Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis. 2012;18(8):1470–1479.
    1. Bickston SJ, Behm BW, Tsoulis DJ, et al. Vedolizumab for induction and maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2014;(8):CD007571.
    1. Feagan B, Kaser A, Smyth M, Panaccione R, Sankoh S, Abhyankar B. Long-term efficacy of vedolizumab therapy for patients with ulcerative colitis. Am J Gastroenterol. 2014;109(suppl 2):S477.
    1. Sands BE, Shafran I, Farraye FA, et al. Efficacy and Safety of Retreatment with Vedolizumab in Patients with Ulcerative Colitis. Vienna: European Crohns and Colitis Organization; 2015.
    1. Govani SM, Waljee AK, Higgins PD. Anti-adhesion therapies and the rule of 3 for rare events. Am J Gastroenterol. 2013;108(12):1831–1832.
    1. Mantzaris GJ. Previous cancer and/or lymphoma in patients with refractory IBD–con: anti-TNF or conventional immunosuppressive treatment. Dig Dis. 2014;32(suppl 1):122–127.
    1. Lakatos PL, Miheller P. Is there an increased risk of lymphoma and malignancies under anti-TNF therapy in IBD? Curr Drug Targets. 2010;11(2):179–186.
    1. Danese S, Fiorino G, Peyrin-Biroulet L, et al. Biological agents for moderately to severely active ulcerative colitis: a systematic review and network meta-analysis. Ann Intern Med. 2014;160(10):704–711.
    1. Feagan B, Colombel J-F, Rubin D, Mody R, Sankoh S, Lasch K. Improvements in Health-Realted Quality of Life in Patients with UC Treated with Vedolizumab. Vienna: European Crohns and Colitis foundation; 2014.
    1. Liu Y, Ozbay AB, Skup M, Reichmann W, Diener M, Chao J. Comparison of cost per responder and remitter in patients with inflammatory bowel disease in the United States: an indirect comparison of adalimumab and vedolizumab. Am Coll Gastroenterol. 2014;109(suppl 2):S479.
    1. Colombel JF, Sandborn WJ, Reinisch W, et al. SONIC Study Group Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010;362(15):1383–1395.

Source: PubMed

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