{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T01:55:23Z","timestamp":1777859723251,"version":"3.51.4"},"reference-count":37,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2016,7,9]],"date-time":"2016-07-09T00:00:00Z","timestamp":1468022400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmacy Practice"],"published-print":{"date-parts":[[2016,10]]},"abstract":"<jats:p>Inflammatory bowel diseases (IBDs) are chronic inflammatory disorders affecting the gastrointestinal (GI) tract that encompass Crohn\u2019s disease (CD) and ulcerative colitis (UC). In these disease states, epithelial damage of the intestinal mucosa is evident due to increased lymphocyte trafficking to the area, which affects the normal intestinal barrier function. Currently available pharmacotherapy can be limited in terms of efficacy and associated toxicities. Newer agents have emerged, including the monoclonal antibody natalizumab, which antagonizes integrin, an important component within the inflammation cascade. Natalizumab works by modulating both the GI and brain biologic responses and as a result there is risk of the opportunistic infection known as progressive multifocal leukoencephalopathy (PML), putting patients at risk for severe disability and death. Vedolizumab, another integrin inhibitor, is selective for modulating the gut biologic response but not the brain, consequently decreasing the risk for PML. To generate information regarding the role of vedolizumab in the treatment of IBD, a literature search was conducted, yielding 7 phase I to III clinical trials. This article serves as a summary of efficacy, safety, and other relevant information from clinical studies to explore the role of vedolizumab in the treatment of CD and UC.<\/jats:p>","DOI":"10.1177\/0897190015579610","type":"journal-article","created":{"date-parts":[[2015,5,7]],"date-time":"2015-05-07T20:41:10Z","timestamp":1431031270000},"page":"503-515","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Vedolizumab"],"prefix":"10.1177","volume":"29","author":[{"given":"Mara","family":"Poulakos","sequence":"first","affiliation":[{"name":"Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jade D.","family":"Machin","sequence":"additional","affiliation":[{"name":"Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julienne","family":"Pauly","sequence":"additional","affiliation":[{"name":"Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasmin","family":"Grace","sequence":"additional","affiliation":[{"name":"Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, FL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2016,7,9]]},"reference":[{"key":"bibr1-0897190015579610","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v20.i28.9458"},{"key":"bibr2-0897190015579610","unstructured":"Inflammatory Bowel Disease. Centers for Disease Control and Prevention Web site. http:\/\/www.cdc.gov\/ibd\/. Accessed on April 20, 2015."},{"key":"bibr3-0897190015579610","unstructured":"Crohn\u2019s and Colitis Foundation of America: Fact Sheet\u2014About Inflammatory Bowel Disease. Web site. http:\/\/www.ccfa.org\/assets\/pdfs\/ibdfactbook.pdf. Accessed on April 20, 2015."},{"key":"bibr4-0897190015579610","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2008.168"},{"key":"bibr5-0897190015579610","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2011.01.055"},{"key":"bibr6-0897190015579610","unstructured":"Hemstreet BA. Inflammatory bowel disease. In: DiPiro JT, Talbert RL, Yee GC, eds. Pharmacotherapy: A Pathophysiologic Approach. 9th ed. New York, NY: McGraw-Hill; 2014:chapter 21. Web site. http:\/\/accesspharmacy.mhmedical.com\/content.aspx?bookid=689&Sectionid=45310476. 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FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) With the Use of Tysabri\n                      \u00ae\n                      (Natalizumab). Silver Spring, MD: Food and Drug Administration; 2010. Web site. http:\/\/www.fda.gov\/drugs\/drugsafety\/postmarketdrugsafetyinformationforpatientsandproviders\/ucm199872.htm. Accessed on April 20, 2015."},{"key":"bibr15-0897190015579610","unstructured":"Food and Drug Administration. Tysabri\n                      \u00ae\n                      Risk Minimization Action Plan: Summary of Touch\n                      \u00ae\n                      . Rockville, MD: Food and Drug Administration; 2005. Web site. http:\/\/www.fda.gov\/downloads\/drugs\/drugsafety\/postmarketdrugsafetyinformationforpatientsandproviders\/ucm107197.pdf. Accessed on April 20, 2015."},{"key":"bibr16-0897190015579610","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215739"},{"key":"bibr17-0897190015579610","volume-title":"Pharmacotherapy Handbook","author":"Wells BG","year":"2012","edition":"8"},{"key":"bibr18-0897190015579610","doi-asserted-by":"crossref","unstructured":"Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am Coll Gastroenterol. 2010;105(3):501\u2013523. Web site. http:\/\/www.dept-med.pitt.edu\/gi\/fellowship\/files\/IBD_Readings\/kornbluth2010.pdf. Accessed on April 20, 2015.","DOI":"10.1038\/ajg.2009.727"},{"key":"bibr19-0897190015579610","unstructured":"Ulcerative Colitis: Management in Adults, Children and Young People\n                      . Manchester: NICE National Institute for Health and Care Excellence; 2013. Web site. http:\/\/www.nice.org.uk\/guidance\/cg166\/resources\/guidance-ulcerative-colitis-pdf. Accessed on April 20, 2015."},{"key":"bibr20-0897190015579610","first-page":"123","volume":"7","author":"Gledhill T","year":"2013","journal-title":"Biologics"},{"key":"bibr21-0897190015579610","unstructured":"Vedolizumab. Lexicomp Web site. http:\/\/online.lexi.com.proxy.pba.edu\/lco\/action\/home\/switch. Accessed on April 20, 2015."},{"key":"bibr22-0897190015579610","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.21896"},{"key":"bibr23-0897190015579610","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-014-0253-1"},{"key":"bibr24-0897190015579610","unstructured":"Entyvio (vedolizumab) [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America Inc; 2014."},{"key":"bibr25-0897190015579610","first-page":"19","author":"Rosario M","year":"2013","journal-title":"Inflamm Bowel Dis"},{"key":"bibr26-0897190015579610","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2008.06.007"},{"key":"bibr27-0897190015579610","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215734"},{"key":"bibr28-0897190015579610","unstructured":"Entyvio [package insert]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; 2014."},{"key":"bibr29-0897190015579610","unstructured":"Center for Drug Evaluation and Research. US Food and Drug Administration Web Site. http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2014\/125476Orig1s000ODMemo.pdf. 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