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The incidence of mPDAI-defined remission at week 14 was 31% in the vedolizumab group, compared to 10% in the placebo group.
About 50% of patients with ulcerative colitis who undergo restorative proctocolectomy with ileal pouch-anal anastomosis also will eventually have pouchitis, 20% of which will have chronic pouchitis.
Acute pouchitis is usually treated with short-term courses of antibiotic agents, but there remains a need for treatments for chronic pouchitis.
In the phase 4, double-blind, randomized trial, a team, led by Simon Travis, D.Phil, Translational Gastroenterology Unit and Kennedy Institute, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford, examined 102 patients with chronic pouchitis treated with vedolizumab after undergoing IPAA for ulcerative colitis.
Each patient was treated with either vedolizumab intravenously 300 mg or placebo on day 1 and week 2, 6, 22, and 30. Every participant was treated with concomitant ciprofloxacin from weeks 1-4.
The investigators sought primary endpoints of modified Pouchitis Disease Activity Index (mPDAI)-defined remission, an mPDAI score of ≤4 and a reduction from baseline of ≥2 points in the mPDAI total score at week 14.
The team also looked for other efficacy endpoints, including mPDAI-defined remission at week 34, mPDAI-defined response, defined as a reduction from baseline of ≥2 points in the mPDAI score) at weeks 14 and 34, and PDAI-defined remission, defined as a PDAI score of ≤6 and a reduction from baseline of ≥3 points.
The mPDAI is based on both clinical symptoms and endoscopic findings and the PDAI is based on clinical symptoms, endoscopic findings, and histologic findings.
The results show the incidence of mPDAI-defined remission at week 14 was 31% (n = 16) in the vedolizumab group, compared to 10% (n = 5) in the placebo group (difference, 21 percentage points; 95% confidence interval [CI], 5-38; P = 0.01).
The differences were also seen in mPDAI-defined remission at week 34 (difference, 17 percentage points; 95% CI, 0-35), mPDAI-defined response at week 14 (difference, 30 percentage points; 95% CI, 8-48) and at week 34 (difference, 22 percentage points; 95% CI, 2-40), and PDAI-defined remission at week 14 (difference, 25 percentage points; 95% CI, 8-41) and at week 34 (difference, 19 percentage points; 95% CI, 2-37).
In the safety analysis, the investigators identified serious adverse events in 6% (n = 3) of the vedolizumab group and 8% (n = 4) of the placebo group.
“Treatment with vedolizumab was more effective than placebo in inducing remission in patients who had chronic pouchitis after undergoing IPAA for ulcerative colitis,” the authors wrote.
Travis, S., Silverberg, M. S., Danese, S., Gionchetti, P., Löwenberg, M., Jairath, V., Feagan, B. G., Bressler, B., Ferrante, M., Hart, A., Lindner, D., Escher, A., Jones, S., & Shen, B. (2023). Vedolizumab for the treatment of chronic pouchitis. New England Journal of Medicine, 388(13), 1191–1200. https://doi.org/10.1056/nejmoa2208450