Mie Dilling Kjær1, Niels Qvist1, Inge Nordgaard-Lassen2, Lisbet Ambrosius Christensen3, Jens Kjeldsen4. 1. a Department of Surgery , Odense University Hospital , Odense C , Denmark. 2. b Department of Medical Gastroenterology , Hvidovre Hospital , Hvidovre , Denmark. 3. c Department of Medical Gastroenterology , Aarhus University Hospital , Aarhus , Denmark. 4. d Department of Medical Gastroenterology , Odense University Hospital , Odense , Denmark.
Abstract
BACKGROUND: Pouchitis is a complication of ileal pouch-anal anastomosis and occurs in up to 50% of patients 10 years after IPAA with 10% developing refractory pouchitis. OBJECTIVE: To evaluate the effect of a TNF-α inhibitor (Adalimumab) in the treatment of refractory pouchitis. MATERIALS AND METHODS: A multicenter, randomized double-blind, placebo-controlled trial includes patients with refractory pouchitis for more than 4 weeks despite antibiotic treatment. Patients were randomized to Adalimumab or placebo for 12 weeks. Primary outcome was reduction in clinical pouchitis disease activity index (PDAI) of ≥2 at any time. Secondary endpoints were remission of pouchitis, endoscopic and histologic effect and quality of life. RESULTS:Thirteen patients were included; six patients receivedactive treatment and seven patients received placebo. Nine patients (5/4, Adalimumab/placebo) completed the 12-week program. Reduction in clinical PDAI ≥ 2 was achieved in three patients in each group (50%/43%, Adalimumab/placebo, p > .5). Total PDAI improved in six patients treated with Adalimumab and two patients on placebo (100%/29%, p = .13). There were no differences in secondary endpoints between the groups. CONCLUSIONS: In this randomized controlled trial of treatment with Adalimumab in patients with refractory pouchitis, we were not able to identify any clinical benefit in the primary or secondary endpoints.
RCT Entities:
BACKGROUND:Pouchitis is a complication of ileal pouch-anal anastomosis and occurs in up to 50% of patients 10 years after IPAA with 10% developing refractory pouchitis. OBJECTIVE: To evaluate the effect of a TNF-α inhibitor (Adalimumab) in the treatment of refractory pouchitis. MATERIALS AND METHODS: A multicenter, randomized double-blind, placebo-controlled trial includes patients with refractory pouchitis for more than 4 weeks despite antibiotic treatment. Patients were randomized to Adalimumab or placebo for 12 weeks. Primary outcome was reduction in clinical pouchitis disease activity index (PDAI) of ≥2 at any time. Secondary endpoints were remission of pouchitis, endoscopic and histologic effect and quality of life. RESULTS: Thirteen patients were included; six patients received active treatment and seven patients received placebo. Nine patients (5/4, Adalimumab/placebo) completed the 12-week program. Reduction in clinical PDAI ≥ 2 was achieved in three patients in each group (50%/43%, Adalimumab/placebo, p > .5). Total PDAI improved in six patients treated with Adalimumab and two patients on placebo (100%/29%, p = .13). There were no differences in secondary endpoints between the groups. CONCLUSIONS: In this randomized controlled trial of treatment with Adalimumab in patients with refractory pouchitis, we were not able to identify any clinical benefit in the primary or secondary endpoints.
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