1,321
Views
27
CrossRef citations to date
0
Altmetric
Drug Safety Evaluation

The safety of vedolizumab for the treatment of ulcerative colitis

, , , &
Pages 501-507 | Received 24 Dec 2016, Accepted 23 Feb 2017, Published online: 05 Mar 2017

References

  • Dignass A, Eliakim R, Magro F, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1: definitions and diagnosis. J Crohns Colitis. 2012;6:965–990.
  • Burisch J, Munkholm P. The epidemiology of inflammatory bowel disease. Scand J Gastroenterol. 2015;50:942–951.
  • Ben-Horin S, Kopylov U, Chowers Y. Optimizing anti-TNF treatments in inflammatory bowel disease. Autoimmun Rev. 2014;13:24–30.
  • McLean LP, Shea-Donohue T, Cross RK. Vedolizumab for the treatment of ulcerative colitis and Crohn’s disease. Immunotherapy. 2012;4:883–898.
  • Bravata I, Allocca M, Fiorino G, et al. Integrins and adhesion molecules as targets to treat inflammatory bowel disease. Curr Opin Pharmacol. 2015;25:67–71.
  • Targan SR, Feagan BG, Fedorak RN, et al. Natalizumab for the treatment of active Crohn’s disease: results of the ENCORE Trial. Gastroenterology. 2007;132:1672–1683.
  • Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2005;353:1912–1925.
  • Kuehn BM. Rare neurological condition linked to newer monoclonal antibody biologics. Jama. 2009;301:1423–1424.
  • Chen Y, Bord E, Tompkins T, et al. Asymptomatic reactivation of JC virus in patients treated with natalizumab. N Engl J Med. 2009;361:1067–1074.
  • Hunt D, Giovannoni G. Natalizumab-associated progressive multifocal leucoencephalopathy: a practical approach to risk profiling and monitoring. Pract Neurol. 2012;12:25–35.
  • 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.
  • Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369:711–721.
  • Soler D, Chapman T, Yang LL, et al. 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;330:864–875.
  • Briskin M, Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol. 1997;151:97–110.
  • 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;64:77–83.
  • 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;352:2499–2507.
  • 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;18:1470–1479.
  • Mosli MH, MacDonald JK, Bickston SJ, et al. Vedolizumab for induction and maintenance of remission in ulcerative colitis: a Cochrane systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21:1151–1159.
  • Arijs I, De Hertogh G, Lemmens B, et al. Effect of vedolizumab (anti-alpha4beta7-integrin) therapy on histological healing and mucosal gene expression in patients with UC. Gut. 2016 Oct 7. Epub ahead of print.doi:10.1136/gutjnl-2016-312293.
  • Takeda. An efficacy and safety study of vedolizumab intravenous (IV) compared to adalimumab subcutaneous (SC) in participants with ulcerative colitis. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2016 Oct 20]. Available from: https://clinicaltrials.gov/ct2/show/study/NCT02497469. NLM Identifier: NCT02497469.
  • Bressler B, Marshall JK, Bernstein CN, et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015;148:1035–1058.
  • Armuzzi A, Gionchetti P, Daperno M, et al. Expert consensus paper on the use of vedolizumab for the management of patients with moderate-to-severe inflammatory bowel disease. Dig Liver Dis. 2016;48:360–370.
  • Dassopoulos T, Cohen RD, Scherl EJ, et al. Ulcerative colitis care pathway. Gastroenterology. 2015;149:238–245.
  • Baumgart DC, Bokemeyer B, Drabik A, et al. Vedolizumab induction therapy for inflammatory bowel disease in clinical practice–a nationwide consecutive German cohort study. Aliment Pharmacol Ther. 2016;43:1090–1102.
  • Amiot A, Grimaud JC, Peyrin-Biroulet L, et al. Effectiveness and safety of vedolizumab induction therapy for patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2016;14:1593–1601.
  • Shelton E, Allegretti JR, Stevens B, et al. Efficacy of vedolizumab as induction therapy in refractory IBD patients: A multicenter cohort. Inflamm Bowel Dis. 2015;21:2879–2885.
  • Hagan M, Cross RK. Safety of vedolizumab in the treatment of Crohn’s disease and ulcerative colitis. Expert Opin Drug Saf. 2015;14:1473–1479.
  • Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn’s disease. Gut. 2016 Feb 18; pii: gutjnl-2015-311079. [ Epub ahead of print]. DOI:10.1136/gutjnl-2015-311079
  • Wang MC, Zhang LY, Han W, et al. PRISMA–efficacy and safety of vedolizumab for inflammatory bowel diseases: a systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2014;93:e326.
  • Yajnik V, Khan N, Dubinsky M, et al. Efficacy and safety of vedolizumab in ulcerative colitis and Crohn’s disease patients stratified by age. Adv Ther. 2017 Jan 9. Epub ahead of print.doi:10.1007/s12325-016-0467-6.
  • Vivio EE, Kanuri N, Gilbertsen JJ, et al. Vedolizumab effectiveness and safety over the first year of use in an IBD clinical practice. J Crohns Colitis. 2016;10:402–409.
  • 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. 2016;90:168–176.
  • Rosario M FI, Milch C, et al. Pharmacokinetic/pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: additional results from GEMINI 1 and 2. Inflamm Bowel Dis. 2013;19(suppl 1):P140.
  • Mocko P, Kawalec P, Pilc A. Safety profile of biologic drugs in the therapy of ulcerative colitis: A systematic review and network meta-analysis. Pharmacotherapy. 2016;36:870–879.
  • Loftus EV Jr, Colombel JF, Feagan BG, et al. Long-term efficacy of vedolizumab for ulcerative colitis. J Crohns Colitis. 2016 Sep 28;jjw177. [ Epub ahead of print].
  • Strik AS, Bots SJ, D’Haens G, et al. Optimization of anti-TNF therapy in patients with Inflammatory Bowel Disease. Expert Rev Clin Pharmacol. 2016;9:429–439.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.