Using vedolizumab monoclonal antibody to treat chronic pouchitis
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by An Duc Thien Le |
Posted on April 10th, 2023
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In some patients with ulcerative colitis, the condition can be treated with a restorative proctocolectomy with ileal pouch–anal anastomosis (IPAA). However, many of them develop chronic pouchitis after the procedure. Vedolizumab is a monoclonal antibody that can bind to the α4β7 integrin and reduce inflammation in the GI tract. Thus, a study, funded by Takeda, was conducted to investigate if vedolizumab can be used to treat chronic pouchitis.
The phase 4 clinical trial included 102 patients who had chronic pouchitis after they had undergone the ileal pouch–anal anastomosis (IPAA) procedure to alleviate their ulcerative colitis. The patients were randomly assigned to receive either placebo or vedolizumab; 300 mg of vedolizumab was administered intravenously after the participants joined the study and at week 2, 6, 14, 22, and 30. Besides the monoclonal antibody, both groups were given one pill of 500 mg ciprofloxacin twice a day for the first 4 weeks. The patient’s health was assessed using the modified Pouchitis Disease Activity Index (mPDAI). By the 14th week, the study found that vedolizumab increased the chance of remission by 21%, and this difference in efficacy was present at 17% by the 34th week. The rate of adverse events were similar between the two groups; however, those in the vedolizumab experienced a higher risk of headache and upper respiratory tract infection.a
The phase 4 clinical trial included 102 patients who had chronic pouchitis after they had undergone the ileal pouch–anal anastomosis (IPAA) procedure to alleviate their ulcerative colitis. The patients were randomly assigned to receive either placebo or vedolizumab; 300 mg of vedolizumab was administered intravenously after the participants joined the study and at week 2, 6, 14, 22, and 30. Besides the monoclonal antibody, both groups were given one pill of 500 mg ciprofloxacin twice a day for the first 4 weeks. The patient’s health was assessed using the modified Pouchitis Disease Activity Index (mPDAI). By the 14th week, the study found that vedolizumab increased the chance of remission by 21%, and this difference in efficacy was present at 17% by the 34th week. The rate of adverse events were similar between the two groups; however, those in the vedolizumab experienced a higher risk of headache and upper respiratory tract infection.a