Phase IV EARNEST study of Entyvio in chronic pouchitis published in NEJM

The NEJM article is titled “Vedolizumab for the Treatment of Chronic Pouchitis”. The published results showed the Phase IV EARNEST study met its primary efficacy endpoint of clinical and endoscopic remission, as measured by modified pouchitis disease activity index (mPDAI), at Week 14 in 31% of participants (16 out of 51) receiving vedolizumab versus 10% (5 out of 51) receiving placebo (95% CI: 5 to 38 percentage point [p.p.] difference; p=0.01). This improved outcome compared with placebo was also seen at the equivalent secondary endpoint at Week 34 (35% of vedolizumab patients [18 out of 51] achieved mPDAI remission compared with 18% [9 out of 51] on placebo [95% CI: 0 to 35 p.p. difference]).

Beyond mPDAI remission, patients receiving vedolizumab also demonstrated improved clinical response at both Week 14 and Week 34 over placebo, with a difference at Week 14 of 30 p.p. (95% CI, 8 to 48), and a Week 34 difference of 22 p.p. (95% CI, 2 to 40). Serious adverse events occurred in 6% (3 out of 51) and 8% (4 out of 51) of patients in the vedolizumab and placebo groups, respectively. No new safety signals were identified. The publication concluded that vedolizumab was more effective than placebo for inducing remission in chronic pouchitis after IPAA for patients with UC.

See: "Vedolizumab for the Treatment of Chronic Pouchitis." Simon Travis et al. N Engl J Med 2023; 388:1191-1200 March 30, 2023 DOI: 10.1056/NEJMoa2208450