Patients treated with the gut-selective monoclonal antibody were three times more likely to achieve remission of inflammation of ileal pouch-anal anastomosis, an alternative to a life-long colostomy bag after colectomy.
Up to 30% of people with ulcerative colitis (UC) will ultimately require colon removal surgery (colectomy). Colectomies are indicated in cases of treatment-resistant inflammatory disease, including UC, and in some cases of colon and rectal cancers.
Standard of care post colectomy has included ileal pouch-anal anastomosis (IPAA). With IPAA, an ileo-anal pouch is constructed from the small intestine, eliminating the need for a life-long colostomy bag.
However, about half of the patients who undergo IPAA develop pouchitis, which is an inflammation of the pouch lining. Antibiotics are the first line of treatment for pouchitis, but approximately one-fifth of patients develop antibiotic-resistant, chronic pouchitis.
A study published last month in The New England Journal of Medicine evaluated the safety and efficacy of Entyvio (vedolizumab) in adults with chronic pouchitis following IPAA for UC. Entyvio is a gut-selective monoclonal antibody indicated for the treatment of moderately to severely active UC and Crohn’s disease and is manufactured by Takeda, which also sponsored the study.
The trial, led by Simon Travis, FRCP, professor of clinical gastroenterology at the Nuffield Department of Medicine, University of Oxford, randomized 102 participants who had developed chronic pouchitis at least a year after colectomy to receive 300 mg of Entyvio or placebo. The patients received doses intravenously on day 1 and at weeks 2, 6, 14, 22, and 30. All participants also received oral ciprofloxacin through week 4 of the trial.
The primary outcome was pouchitis remission as defined by the modified Pouchitis Disease Activity Index (mPDAI) at week 14. An mPDAI score of 4 or less and a reduction from baseline of at least 2 points indicated remission. The results showed that patients who received Entyvio were three times more likely to achieve remission than those who received placebo (31% versus 10%).
Entyvio was also superior in reaching secondary endpoints, including mPDAI-defined remission at week 34 and mPDAI-defined response (reduction from baseline of at least 2 points) at weeks 14 and 34. Serious adverse events were similar in both groups, with a rate of 6% in the vedolizumab group and 8% in the placebo group.
Travis and his colleagues concluded that treatment with intravenous vedolizumab is more effective than placebo in inducing remission at week 14 in adults with chronic pouchitis after IPAA surgery for UC.