A study led by Oxford researchers has found that the drug vedolizumab can induce remission in patients who have chronic pouchitis after surgery for ulcerative colitis.
Twelve percent of people with ulcerative colitis need surgery to have their colon removed. Most have an ileo-anal pouch surgically constructed from their small bowel, which means that they do not have to live with a stoma bag.
Sadly, after surgery there is a risk of inflammation developing in the lining of the pouch, a condition known as pouchitis. Antibiotics are the first-line treatment to reduce the inflammation, but one fifth will go on to develop chronic, antibiotic-refractory pouchitis.
Simon Travis, Professor of Clinical Gastroenterology at the University of Oxford’s Kennedy Institute and the Translational Gastroenterology Unit at the John Radcliffe Hospital, ran an international randomised trial to evaluate the effect of vedolizumab on chronic pouchitis.
The trial was funded by the pharmaceutical company Takeda and supported by the NIHR Oxford Biomedical Research Centre (BRC). Oxford was one of the highest recruiting centres in the trial.
Professor Travis explained: “Vedolizumab is widely used for treating ulcerative colitis and this study shows that it is effective for pouchitis that recurs rapidly or persists in spite of antibiotics. Vedolizumab has become the first treatment in Europe licensed for pouchitis that does not respond to antibiotics. That’s a game changer for these patients.”
Published in the New England Journal of Medicine (NEJM), the trial randomised 102 adults who had developed chronic pouchitis after colectomy. Half the patients were assigned to receive 300mg of vedolizumab, the other half a placebo, administered at day one, and weeks two, six, 14, 22 and 30. Both groups also received the antibiotic ciprofloxacin from weeks 1 to 4.
Those patients receiving vedolizumab were three times more likely to achieve remission at week 14 than those receiving placebo. There was a significant difference at in remission at week 34, sustained remission and quality of life.
Professor Travis (left) said: “It’s an awful thing for patients to get pouchitis after suffering such severe ulcerative colitis that they need surgery, which they thought would solve their bowel condition. The EARNEST trial of vedolizumab is really encouraging, because the treatment clearly works.
“In subsequent research we have shown that vedolizumab significantly improves mucosal healing in pouchitis. Vedolizumab is available for treatment of ulcerative colitis and Crohn’s disease in the UK, Europe and around the world.”