Oral budesonide in the treatment of chronic refractory pouchitis

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.