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Vedolizumab use in patients with inflammatory bowel diseases undergoing surgery:clinical trials and post-marketing experience

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Gastroenterology Report 2019年第5期7卷 322-330,I0001页

作者： Bo Shen aimee blake Karen Lasch Michael Smyth Fatima Bhayat Center for Inflammatory Bowel Disease Digestive Disease and Surgery InstituteCleveland ClinicClevelandOHUSA Global Patient Safety Evaluation Takeda Pharmaceuticals International Co.CambridgeMAUSA US Medical Office Takeda Pharmaceuticals USA Inc.DeerfieldILUSA Global Medical Affairs Takeda Development Centre Europe LtdLondonUK Kyowa Kirin International plc ChertseyUK

Background:Patients with inflammatory bowel diseases frequently require surgery,but immunotherapies used in disease management may increase the risk of post-operative *** investigated frequencies of post-operative complications in patients who received vedolizumab—a gut-selective antibody approved for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease—in clinical-trial and post-marketing ***:This post hoc analysis of safety data from GEMINI 1,GEMINI 2,and long-term safety studies included patients who had had colectomy or bowel surgery/*** from the post-marketing Vedolizumab Global Safety Database were also analysed(data cutoff point:19 May 2016).Adverse events relating to post-operative complications were identified using Medical Dictionary for Regulatory Activities preferred ***:Of 58 total surgeries in patients included in GEMINI 1 and GEMINI 2,post-operative complications were reported for 3/51 vedolizumab-treated patients(5.9%)and 1/7 placebo-treated patients(14.3%).In the long-term safety study,157/2,243 patients(7%)had colectomy or bowel surgery/resection;of these 157 patients who underwent surgery,11(7%)experienced a post-operative *** time between last pre-operative vedolizumab dose and surgery was 23 days in GEMINI 1,20 days in GEMINI 2,and 39–40 days in the long-termsafety *** the post-marketing setting,based on data covering approximately 46,978 patient-years of vedolizumab exposure,post-operative complications were reported in 19 ***:In clinical trials,complications of colectomy and bowel surgery/resection appeared infrequent,with minimal difference between vedolizumab and *** frequency of post-operative complications in the post-marketing setting appears low.

关键词： inflammatory bowel disease colorectal surgery vedolizumab

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