IV vedolizumab effectively treats chronic pouchitis in UC
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Among patients with ulcerative colitis, IV vedolizumab safely and effectively treated chronic pouchitis following ileal pouch-anal anastomosis, according to research presented at the Congress of European Crohn’s and Colitis Organization.
“Pouchitis is recognized by all clinicians as a common complication of a pouch formation for patients with an original diagnosis of ulcerative colitis, and indeed, as many as half patients may develop pouchitis within five years,” Simon Travis, DPhil, FRCP, professor of clinical gastroenterology at the University of Oxford, said. “Antibiotics is recommended as first-line treatment, but antibiotic refractoriness is common. ... At the time of the study, there were no approved therapies for antibiotic refractory pouchitis.”
Travis and colleagues conducted a randomized, double-blind, placebo-controlled trial to investigate vedolizumab use among 102 patients with UC and chronic pouchitis following proctocolectomy with ileal pouch-anal anastomosis. Patients received either IV vedolizumab 300 mg (n = 51; mean age 40.8 years) or placebo (n = 51; mean age 42.9 years) on day 1 and at weeks 2, 6, 14, 22 and 30; participants also received ciprofloxacin through week 4.
Studied endpoints included modified Pouchitis Disease Activity Index (mPDAI) remission at week 14, as well as additional endoscopic exploratory endpoints assessed at weeks 14 and 34. Researchers monitored safety signals throughout the study.
At week 14, researchers observed mPDAI remission rates of 31.4% in the vedolizumab group vs. 9.8% in the control group. In addition, they noted increased rates of sustained remission at weeks 14 and 34 for mPDAI (27.5% vs. 5.9%; 95% CI, 6.5-37), as well as PDAI (31.4% vs. 7.8%; 95% CI 8-38.8).
Further, results showed patients receiving vedolizumab had greater reduction in the number of ulcers from baseline; a higher proportion of patients in this group also had improved SES-CD scores and achieved SES-CD remission of pouchitis.
“This is the first and largest randomized double blind, placebo-controlled study for patients with pouchitis and an original diagnosis of ulcerative colitis,” Travis concluded. “It showed consistent benefits across clinical, endoscopic and histological endpoints and the safety profile, which is no different to that expected; there was a concomitant improvement in the health-related quality of life.”
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Travis S, et al. Abstract OP04. Presented at: Congress of European Crohn’s and Colitis Organization; February 16-19, 2022 (virtual meeting).
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