Adalimumab in the treatment of chronic pouchitis. A randomized double-blind, placebo-controlled trial

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 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.

Keywords:

• Ileal pouch-anal anastomosis
• pouchitis
• TNF-α inhibitor
• ulcerative colitis
• inflammatory bowel disease

Acknowledgments

Special gratitude goes to Anne Berg, Lisbet Gerdes, Toto Markussen and Carina Margaretha Blixt for handling patient contact.

Disclosure statement

No conflict of interests was declared by any author.

Additional information

Funding

This work was supported by AbbVie A/S [CVR: 34 46 28 28].