6/28/23, 9:49 PM EARNEST Pathway Feedback Search Clinical Topics Home Studies EARNEST EARNEST Disease Ulcerative colitis Trial question What is the role of vedolizumab in patients who developed chronic pouchitis after undergoing ileal pouch-anal anastomosis for ulcerative colitis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 31.0% female N = 102 69.0% male 102 patients (32 female, 70 male) Inclusion criteria: adult patients who developed chronic pouchitis after undergoing ileal pouch- anal anastomosis for ulcerative colitis Key exclusion criteria: Crohn's disease; irritable pouch syndrome; active or latent tuberculosis; chronic hepatitis B or chronic HCV infection Interventions N=51 vedolizumab (intravenous infusion at a dose of 300 mg on day 1 and at weeks 2, 6, 14, 22, and 30 plus ciprofloxacin from week 1 to 4) N=51 placebo (intravenous infusion of a matching placebo on day 1 and at weeks 2, 6, 14, 22, and 30 plus ciprofloxacin from week 1 to 4) Primary outcome Modified Pouchitis Disease Activity Index-defined remission at week 14 https://web.pathway.md/studies/recGWpERKKo9YzPIP 1/2 6/28/23, 9:49 PM EARNEST Pathway 31.0 % 31 23.3 % 15.5 % Significant increase 10 7.8 % NNT = 5 0.0 % Vedolizumab Placebo Significant increase in modified Pouchitis Disease Activity Index-defined remission at week 14 (31% vs. 10%; AD 21%, 95% CI 5 to 38) Secondary outcomes Borderline significant increase in modified Pouchitis Disease Activity Index-defined remission at week 34 (35% vs. 18%; AD 17%, 95% CI 0 to 35) Significant increase in modified Pouchitis Disease Activity Index-defined response at week 14 (63% vs. 33%; AD 30%, 95% CI 8 to 48) Significant increase in Pouchitis Disease Activity Index-defined remission at week 14 (35% vs. 10%; AD 25%, 95% CI 8 to 41) Safety outcomes No significant difference in serious adverse events. Conclusion In adult patients who developed chronic pouchitis after undergoing ileal pouch-anal anastomosis for ulcerative colitis, vedolizumab was superior to placebo with respect to modified Pouchitis Disease Activity Index-defined remission at week 14. Reference Simon Travis, Mark S Silverberg, Silvio Danese et al. Vedolizumab for the Treatment of Chronic Pouchitis. N Engl J Med. 2023 Mar 30;388(13):1191-1200. Open reference URL https://web.pathway.md/studies/recGWpERKKo9YzPIP 2/2