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Vedolizumab first approved therapy for chronic pouchitis

Presented By
Prof. Simon Travis, University of Oxford, UK
ECCO 2022
Phase 4, EARNEST

Vedolizumab showed clinical, endoscopic, and histologic benefits over placebo in participants with chronic pouchitis after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC). The safety profile of vedolizumab was consistent with previous data published on this agent. The phase 4 EARNEST trial is the first and largest randomised-controlled trial to demonstrate significant benefits of a biologic therapy in patients with chronic pouchitis.

Prof. Simon Travis (University of Oxford, UK) explained that although antibiotics are the standard treatment for acute pouchitis, therapies for chronic antibiotic-refractory pouchitis are lacking [1]. Therefore, the double-blind, placebo-controlled EARNEST trial (NCT02790138) randomised participants with chronic pouchitis after proctocolectomy with IPAA for UC (n=102) 1:1 to vedolizumab (300 mg, intravenous, administered at day 1 and weeks 2, 6, 14, 22, and 30) or placebo. Additionally, all participants received 500 mg twice daily ciprofloxacin for the first 4 weeks. Remission at week 14, defined by a modified Pouchitis Disease Activity Index (mPDAI) score <5 and a ≥2-point reduction from baseline, was the primary endpoint of this study.

Vedolizumab outperformed placebo with respect to the primary endpoint (mPDAI remisson 31.4% vs 9.80%; P=0.013). In addition, mPDAI response rates favoured vedolizumab over placebo after 14 weeks (62.7% vs 33.3%; P=0.003) and 34 weeks (51.0% vs 29.4%; P=0.026). Sustained mPDAI remission rates were higher in the vedolizumab arm than in the placebo arm (27.5% vs 5.90%). Furthermore, larger histologic and endoscopic improvements were seen in participants who were treated with vedolizumab. “These improvements in pouchitis disease activity among participants treated with vedolizumab were reflected in improvements in health-related quality of life,” added Prof. Travis. At week 34, IBDQ remission rates (score ≥ 170) were observed in 43% of the patients on vedolizumab and in 19.6% of the patients on placebo (95% CI 4.9-40.7).

The safety analysis did not show new safety issues of vedolizumab. Treatment-related adverse events occurred in 21.6% and 23.5% of the participants in the placebo group and the vedolizumab group, respectively. In total, 5 adverse events-related treatment discontinuations were reported in the placebo arm compared with 1 in the vedolizumab arm.

“On 31 January 2022, vedolizumab was approved by the EMA for the treatment of adult patients with moderately to severely active chronic pouchitis who underwent proctocolectomy and IPAA for UC and displayed an inadequate response to antibiotics,” concluded Prof. Travis.

  1. Travis S, et al. Vedolizumab intravenous is effective across multiple treatment targets in chronic pouchitis: Results of the randomised, double-blind, placebo-controlled EARNEST trial. OP04, ECCO 2022, 16–19 February.

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