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Background: Pouchitis is the major long-term complication after ileal-pouch nal anastomosis for ulcerative colitis. Ten to 15% of patients develop a chronic pouchitis, either treatment responsive or treatment refractory.
Aim: To evaluate the efficacy of oral budesonide in inducing remission and improving quality of life in patients with chronic refractory pouchitis.
Methods: Twenty consecutive patients with active pouchitis, not responding after 1 month of antibiotic treatment were treated with budesonide controlled ileal release 9 mg/day for 8 weeks. Symptomatic, endoscopic and histological evaluations were undertaken before and after treatment according to Pouchitis Disease Activity Index. Remission was defined as a combination of Pouchitis Disease Activity Index clinical score of ≤ 2, endoscopic score of ≤ 1 and total Pouchitis Disease Activity Index score of ≤ 4. The quality of life was assessed with the Inflammatory Bowel Disease Questionnaire.
Results: Fifteen of 20 patients (75%) achieved remission. The median total Pouchitis Disease Activity Index scores before and after therapy were, respectively, 14 (range 9-16) and 3 (range 2-10) ( P < 0.001). The median Inflammatory Bowel Disease Questionnaire score also significantly improved from 105 (range 77-175) to 180 (range 85-220) ( P < 0.001).
Conclusion: Eight-week treatment with oral budesonide appears effective in inducing remission in patients with active pouchitis refractory to antibiotic treatment in this open-label study.
Total proctocolectomy with ileal pouch-anal anastomosis (IPAA) has emerged over the past 15 years as the surgical procedure of choice for the management of ulcerative colitis (UC). Pouchitis, a non-specific, idiopathic inflammation of the ileal reservoir, has become the most frequent long-term complication following pouch surgery for UC. [1] The reported incidence of pouchitis is largely variable because of differences in nature and duration of the follow-up and, particularly, because a myriad of diagnostic criteria have been used to define this syndrome. [2-7] Most patients who develop acute pouchitis do so within the first year, but some may suffer their first attack some years following surgery. [4]
This syndrome is clinically characterized by variable symptoms including increased stool frequency and fluidity, rectal bleeding, abdominal cramping, urgency and tenesmus, incontinence, fever and extraintestinal manifestation. [8] A clinical diagnosis should be confirmed by endoscopy and histology. The endoscopic features of pouchitis include mucosal erythema, oedema, friability, petechiae, granularity, loss of vascular pattern, erosions and superficial ulceration. Histological examination shows an acute inflammatory infiltrate with crypt abscesses and ulceration in addition to a chronic inflammation, including villous atrophy, crypt hyperplasia, which is almost universal and probably represent an adaptive response of the pouch mucosa to faecal stasis. [9] The absence of clear and universally accepted criteria for diagnosis, classification and definition of activity has determined a great variability in the results of reports on the incidence of pouchitis, and in the assessment of therapy. To overcome this problem, Sandborn et al. developed a Pouchitis Disease Activity Index (PDAI) ( Table 1 ). [10] This 18-point index is based on clinical symptoms and endoscopic appearance as well as acute histological findings, and represent an objective and reproducible scoring system for pouchitis. Active pouchitis is defined as a score ≥ 7 and remission is defined as a score < 7.
Treatment of pouchitis is largely empiric and only few small placebo-controlled trials have been conducted. Antibiotics are the mainstay of treatment, and metronidazole and ciprofloxacin are the most common initial approaches with a rapid dramatic response. [11-14] Ten to 15% of patients with pouchitis experience a chronic pouchitis either 'treatment responsive' or 'treatment refractory'. [8] Patients with treatment-responsive chronic pouchitis respond to therapy, but when the therapy is stopped, pouchitis relapses. Patients with treatment-refractory pouchitis do not respond to conventional available therapies, and continue to suffer symptoms. Anecdotal experiences have reported satisfactory results with oral and topical corticosteroids. [15,16]
Budesonide is a synthetic steroid with a high topical glucocorticoid activity and with low systemic bioavailability caused by a high first-pass hepatic metabolism. Controlled-ileal-release (CIR) budesonide is enteric coated and designed to deliver budesonide to the terminal ileum and proximal colon, where Crohn's disease is most common. In clinical trials, budesonide was superior than placebo and comparable with traditional steroids for the treatment of Crohn's disease, with fewer side-effects. [17,18] Budesonide enemas have been shown to be as effective as metronidazole in active pouchitis, in a double-blind, double-dummy trial, [19] and recently it has been suggested that the use of budesonide CIR may be effective in the treatment of acute pouchitis. [20] Based on this background, we hypothesized that oral budesonide could be a rational therapeutic option for patients with refractory pouchitis.
Aim of this study was to evaluate the efficacy of oral budesonide for treatment of patients with chronic refractory pouchitis, as well as its impact on their quality of life.
