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BACKGROUND AND AIMS: Vedolizumab is a gut-selective antibody to α4β7 integrin approved to treat moderate-to-severe ulcerative colitis and Crohn's disease in adults. Clinical trial data on patients meeting protocol-specified criteria may not reflect real-world clinical practice. This is a descriptive analysis of 4 years of post-marketing safety data on vedolizumab. METHODS: The Vedolizumab Global Safety Database contains all adverse event reports collated by Takeda Pharmaceutical Company Ltd since vedolizumab approval [20-May-2014]. Adverse event reports received between approval and 19-May-2018 were identified using Medical Dictionary for Regulatory Activities version 21.0 Preferred Terms. Adverse event frequencies were calculated and categorized. RESULTS: In approximately 208,050 patient-years of vedolizumab exposure, 32,752 patients reported 80,218 events. In patients with Crohn's disease and ulcerative colitis, 37,662 and 34,259 events occurred in 14,191 and 14,042 patients, respectively, while 8297 events occurred in 4519 individuals with other [off-label] or unreported indications. Overall, 5230 [14%; Crohn's disease] and 3580 [10%; ulcerative colitis] events were serious. Most frequently reported were gastrointestinal events [Crohn's disease, 6156 (16%) ulcerative colitis, 5701 (17%)]. Patients with Crohn's disease and ulcerative colitis reported 251 malignancies [<1%], 402 hepatobiliary events [<1%] and 5876 infections [1137 serious (19%), 301 opportunistic (5%)]. Patients aged ≥70 years [2326 patients] reported <10% of events. CONCLUSIONS: Adverse event patterns were consistent with clinical trials, with no new safety concerns. Most reported events were non-serious and event frequency was low, considering patient-years of exposure. While limitations of post-marketing safety reports require acknowledgement, these real-world data support a favourable safety profile of vedolizumab.

Original publication




Journal article


J Crohns Colitis

Publication Date



Clinical trials