Vedolizumab (2) – Entyvio®

• Clinical trials
  • For the assessment of the additional benefit of vedolizumab in adults with moderate to severe active chronic pouchitis who have undergone a proctocolectomy for ulcerative colitis, during which an ileoanal pouch was created, and who have responded inadequately or not at all to antibiotic treatment, the pharmaceutical manufacturer did not submit any direct comparative studies against the appropriate comparator therapy.

Adults with moderate to severe active chronic pouchitis who have undergone proctocolectomy for ulcerative colitis, during which an ileoanal pouch was created, and who have responded inadequately or not at all to antibiotic treatment

• An additional benefit is not proven.
• Consequently, there are no suitable data available for assessing the additional benefit of vedolizumab compared with the appropriate comparator therapy. This provides no hint of an additional benefit of vedolizumab over treatment as directed by a doctor.
• Overall, for adults with moderate to severe active chronic pouchitis who have undergone a proctocolectomy with creation of an ileoanal pouch due to ulcerative colitis, and who have responded inadequately or not at all to antibiotic treatment, additional benefit is not proven.

Courtesy translation only, please refer to the German original.