Peter Hoffmann1, Johannes Krisam2, Wolfgang Stremmel3, Annika Gauss3. 1. Department of Gastroenterology and Hepatology, University Hospital Heidelberg, Heidelberg, Germanypeter.hoffmann@med.uni-heidelberg.de. 2. Department of Medical Biometry, University Hospital Heidelberg, Institute of Medical Biometry and Informatics, Heidelberg, Germany. 3. Department of Gastroenterology and Hepatology, University Hospital Heidelberg, Heidelberg, Germany.
Abstract
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 α [TNFα] naive) and 28 patients with Crohn's disease (10.7% anti-TNFα 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.
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-tumornecrosis factor α [TNFα] naive) and 28 patients with Crohn's disease (10.7% anti-TNFα naive, 53.6% having undergone at least one intestinal surgery) were enrolled. Among the ulcerative colitispatients, 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 diseasepatients, vedolizumab was efficacious in achieving response. However, the majority of the patients were not satisfactorily treated, as they did not reach remission.