1. In this randomized controlled trial, vedolizumab induced remission in patients with chronic pouchitis after undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis as compared to a placebo.
2. The incidence of overall and severe adverse events was comparable between groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Restorative proctocolectomy with IPAA is routinely performed for patients with ulcerative colitis who undergo colectomy. Pouchitis (idiopathic inflammation of the pouch) is the most common complication of IPAA. Acute pouchitis is commonly treated with antibiotic agents and can progress to chronic pouchitis when symptoms last over four weeks. Vedolizumab is a gut-selective monoclonal antibody associated with positive treatment outcomes in pouchitis that are refractory to antibiotics. In this randomized controlled trial, adult patients with active chronic pouchitis that have undergone a proctocolectomy and IPAA for ulcerative colitis were randomized to receive oral ciprofloxacin plus placebo or vedolizumab at day one and at weeks two, six, 14, 22, and 30. Patients were followed for 34 weeks. The percentage of patients who had remission defined by the modified Pouchitis Disease Activity Index (mPDAI) at week 14 was significantly higher in the vedolizumab group compared to the placebo group. No significant difference was found in the change from baseline in health-related quality of life, as defined by the Inflammatory Bowel Disease Questionnaire (IBDQ) and Cleveland Global Quality of Life (CGQL) scores. For treatment safety, overall and severe adverse events did not differ significantly between groups. As limitations, mPDAI is not a fully validated instrument for evaluating pouchitis outcomes, and concomitant antibiotics use was more common in the vedolizumab group, which may bias results.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: In this phase four, double-blinded, randomized controlled trial, adult patients with active chronic pouchitis and a history of proctocolectomy with IPAA for ulcerative colitis in the last year were randomized in a 1:1 ratio to receive intravenous vedolizumab 300 mg (n = 51) or placebo (n = 51) on day one and at weeks two, six, 14, 22, and 30. All patients received concomitant oral ciprofloxacin 500 mg twice daily for four weeks and as needed for pouchitis flares after week 14. Patients were followed for 34 weeks. The treatment completion rate was 71% and 63% in the vedolizumab and placebo groups, respectively. For the primary outcome, significantly more patients in the vedolizumab group than the placebo group achieved mPDAI-defined remission at week 14 (31% and 10%, respectively; difference of 21 percentage points; 95% Confidence Interval [CI], 5 to 38). For secondary outcomes, significantly more patients achieved mPDAI-defined remission at week 34 in the vedolizumab group compared to the placebo group (difference of 17 percentage points; 95% CI, 0 to 35). There were no differences between groups in the mean change from baseline in quality of life measures using IBDQ and CGQL scores. The average number of ulcers and erosions decreased from baseline to week 14 (mean difference, -10.1; 95% CI, -17.7 to -2.5) in the vedolizumab group and increased in the placebo group. For safety outcomes, vedolizumab and placebo groups did not differ significantly in overall (92% and 86% of patients, respectively) or serious (6% and 8% of patients, respectively) adverse events. The incidence of pouchitis, upper respiratory tract infections, and headaches were higher in the vedolizumab group than in the placebo group. In summary, this study showed that vedolizumab treatment was more effective than placebo in inducing remission in patients with chronic pouchitis after undergoing IPAA for ulcerative colitis.
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