Management of refractory fistulizing pouchitis with infliximab.

UNLABELLED This study provides the long-term follow-up data on the efficacy of infliximab in the treatment of chronic refractory pouchitis complicated by fistulae following ileo-pouch anal anastomosis (IPAA) for ulcerative colitis (UC). METHODS Seven patients (4 F, 3 M) with chronic refractory pouchitis complicated by fistulae were included in an open study. Pouchitis was diagnosed by clinical plus endoscopical and histological criteria. Fistulae were: pouch-bladder in 1, vaginal in 3, perianal in 2, both vaginal and perianal in 1 patient. Extraintestinal manifestations were present in 4 patients. All the patients were refractory to antibiotics (3 patients also to steroids). Crohn's disease was carefully excluded in all patients after re-evaluation of the history, re-examination of the original proctocolectomy specimen, examination of the proximal small bowel. Patients received Infliximab 5 mg/kg at 0, 2 and 6 weeks. Azathioprine (2.5 mg/kg) was also started for all patients as bridge therapy. Clinical response was classified as complete, partial, and no response. Fistulae closure was classified as complete, partial, and no closure. The pouchitis disease activity index (PDAI) and quality of life (QoL) were also used as outcome measures. RESULTS Clinically, all patients improved. At 10-week follow-up, 6 out of 7 patients had a complete clinical response, and 5 out of 7 patients had complete fistulae closure. At 10- week follow-up, median PDAI dropped from 12 (baseline) (range, 10-15) to 5 (range, 3-8); median QoL decreased from 37 (range, 33-40) to 14 points (range, 9-18), respectively. Extraintestinal manifestations (erythema nodosum and arthralgiae) completely remitted soon after the first infusion of infliximab. Clinical response and fistulae closure were maintained in the long-term follow-up. CONCLUSIONS These results seem indicate that infliximab plus azathioprine may be recommended for the treatment of refractory pouchitis complicated by fistulae following IPAA for UC.