In patients with chronic pouchitis following restorative proctocolectomy with ileal pouch–anal anastomosis (IPAA) in patients with ulcerative colitis, the gut-selective monoclonal antibody vedolizumab induced remission significantly more often than placebo, a phase 4 study shows. About half of patients with IPAA develop pouchitis, and this becomes chronic in about one-fifth of those individuals.
Adults with chronic pouchitis randomly received placebo or intravenous vedolizumab 300 mg on day 1 and at weeks 2, 6, 14, 22, and 30. All received concomitant ciprofloxacin from weeks 1 to 4. Based on a primary endpoint of modified Pouchitis Disease Activity Index (mPDAI)–defined remission at week 14, the investigators found: “Among the 102 patients who underwent randomization, the incidence of mPDAI-defined remission at week 14 was 31% (16 of 51 patients) with vedolizumab and 10% (5 of 51 patients) with placebo (difference, 21 percentage points; 95% confidence interval [CI], 5 to 38; P=0.01). Differences in favor of vedolizumab over placebo were also seen with respect to mPDAI-defined remission at week 34 (difference, 17 percentage points; 95% CI, 0 to 35), mPDAI-defined response at week 14 (difference, 30 percentage points; 95% CI, 8 to 48) and at week 34 (difference, 22 percentage points; 95% CI, 2 to 40), and PDAI-defined remission at week 14 (difference, 25 percentage points; 95% CI, 8 to 41) and at week 34 (difference, 19 percentage points; 95% CI, 2 to 37). Serious adverse events occurred in 3 of 51 patients (6%) in the vedolizumab group and in 4 of 51 patients (8%) in the placebo group.”