[Oral budesonide in the treatment of chronic refractory pouchitis]

Pouchitis is the most frequent complication following total proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis. Up to 15% of patients with pouchitis experience a chronic course, which can be resistant to antibiotic therapy and may lead to surgical excision of the pouch. Further therapeutic options are therefore needed. Oral budesonide, a corticosteroid with topical activity in the terminal ileum (controlled ileal release [CIR] capsules), may be an alternative.

We performed a prospective, open study of five patients with chronic refractory pouchitis. Patients were treated with 9 mg of budesonide capsules after other causes of the lack of treatment response were excluded. Assessments included clinical, endoscopic and histological evaluation at baseline and after 8 weeks of treatment. Efficacy was evaluated using the pouchitis disease activity index (PDAI) global scores as well as the clinical, endoscopic and histological subscores at baseline and 8 weeks. Remission was defined as a global score < 7. Variations in laboratory parameters and tolerance were also assessed.

Four out of five patients went into remission at 8 weeks and a significant decrease was observed in the median total PDAI score from 14 (range, 12-15) to 4 (range, 4-11) (p = 0.0422) and in the three subscores: clinical from 4 (range, 4-5) to 1 (range, 0-4) (p = 0.0394), endoscopic from 5 (range, 4-6) to 2 (range, 1-5) (p = 0.0394), and histologic from 4 (range, 4-5) to 2 (range, 2-2) (p = 0.0339). No significant adverse effects were reported.

Oral budesonide CIR capsules may be an option to induce remission in active chronic refractory pouchitis. Because tolerance is good, the use of enemas may be avoided.