EARNEST
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
69.0% male
N = 102
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
31%
10%
31.0 %
23.3 %
15.5 %
7.8 %
0.0 %
Vedolizumab
Placebo
Significant
increase ▲
NNT = 4
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.
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