PMID- 30134234 OWN - NLM STAT- MEDLINE DCOM- 20181224 LR - 20181224 IS - 1421-9875 (Electronic) IS - 0257-2753 (Linking) VI - 37 IP - 1 DP - 2019 TI - Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn's Disease at a Tertiary Referral Center. PG - 33-44 LID - 10.1159/000492322 [doi] AB - BACKGROUND: Vedolizumab was approved for the therapy of ulcerative colitis and Crohn's disease in mid-2014. Real-world treatment data are necessary for a balanced assessment of its position among other therapeutic options. SUMMARY: Patients with ulcerative colitis or Crohn's disease, initiating vedolizumab therapy at the outpatient clinic for inflammatory bowel diseases at the University Hospital -Heidelberg between June 1, 2014 and August 31, 2016, were recruited based on electronic medical records. The primary study endpoint was response at week 30, while the secondary endpoints were the need for surgery and discontinuation of therapy due to inadequate response, or adverse events. Twenty-five patients with ulcerative colitis (40% anti-tumor necrosis factor alpha [TNFalpha] naive) and 28 patients with Crohn's disease (10.7% anti-TNFalpha naive, 53.6% having undergone at least one intestinal surgery) were enrolled. Among the ulcerative colitis patients, 20% achieved remission, 32% partial response, and 48% were non-responders to vedolizumab. In Crohn's disease, 14.3% of the patients achieved remission, 46.4% partial response, and 39.4% were non-responders. Two patients discontinued vedolizumab therapy due to suspected side effects. Key Message: In a relatively treatment-refractory cohort of inflammatory bowel disease patients, vedolizumab was efficacious in achieving response. However, the majority of the patients were not satisfactorily treated, as they did not reach remission. CI - (c) 2018 S. Karger AG, Basel. FAU - Hoffmann, Peter AU - Hoffmann P AD - Department of Gastroenterology and Hepatology, University Hospital Heidelberg, Heidelberg, Germanypeter.hoffmann@med.uni-heidelberg.de. FAU - Krisam, Johannes AU - Krisam J AD - Department of Medical Biometry, University Hospital Heidelberg, Institute of Medical Biometry and Informatics, Heidelberg, Germany. FAU - Stremmel, Wolfgang AU - Stremmel W AD - Department of Gastroenterology and Hepatology, University Hospital Heidelberg, Heidelberg, Germany. FAU - Gauss, Annika AU - Gauss A AD - Department of Gastroenterology and Hepatology, University Hospital Heidelberg, Heidelberg, Germany. LA - eng PT - Journal Article DEP - 20180822 PL - Switzerland TA - Dig Dis JT - Digestive diseases (Basel, Switzerland) JID - 8701186 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 9RV78Q2002 (vedolizumab) SB - IM MH - Adult MH - Aged MH - Antibodies, Monoclonal, Humanized/*therapeutic use MH - Cohort Studies MH - Colitis, Ulcerative/*drug therapy MH - Crohn Disease/*drug therapy MH - Endpoint Determination MH - Female MH - Humans MH - Male MH - *Referral and Consultation MH - *Tertiary Care Centers MH - Time Factors MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Crohn's disease OT - Inflammatory bowel disease OT - Real-world OT - Ulcerative colitis OT - Vedolizumab EDAT- 2018/08/23 06:00 MHDA- 2018/12/26 06:00 CRDT- 2018/08/23 06:00 PHST- 2018/03/07 00:00 [received] PHST- 2018/07/23 00:00 [accepted] PHST- 2018/08/23 06:00 [pubmed] PHST- 2018/12/26 06:00 [medline] PHST- 2018/08/23 06:00 [entrez] AID - 000492322 [pii] AID - 10.1159/000492322 [doi] PST - ppublish SO - Dig Dis. 2019;37(1):33-44. doi: 10.1159/000492322. Epub 2018 Aug 22.