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P262. Patients with refractory pouchitis receiving adalimumab may avoid permanent ileostomy

M. Ferrante1, G. Van Assche1, S. Vermeire1, M. Noman1, G. De Hertogh2, A. Wolthuis3, F. Penninckx3, A. D'Hoore3, P. Rutgeerts1

1University Hospital Leuven, Department of Gastroenterology, Leuven, Belgium; 2University Hospital Leuven, Department of Pathology, Leuven, Belgium; 3University Hospital Leuven, Department of Abdominal Surgery, Leuven, Belgium

Background: A substantial proportion of patients with ulcerative colitis (UC) undergoing proctocolectomy with ileal pouch-anal anastomosis (IPAA) develop debilitating complications of the pouch. Since clinical evidence for the use of adalimumab (ADA) in patients with refractory pouchitis is limited, we evaluated the efficacy of ADA in our tertiary referral centre.

Methods: Since May 2008, 8 IPAA patients (3 female, median age 40 years) received treatment with ADA (induction 160/80 mg, maintenance 40 mg every other week) for chronic refractory pouchitis. Short-term clinical response was evaluated at week 10 and was defined as complete in case of cessation of diarrhoea, urgency, incontinence, blood loss and abdominal pain, and as partial in case of marked clinical improvement, but persisting symptoms. The modified pouchitis disease activity index (mPDAI) was calculated were available. All patients had undergone IPAA for intractable UC and developed pouchitis and chronic refractory pouchitis after a median (IQR) of 0.9 (0.7–2.0) and 3.6 (2.6–4.1) years, respectively. Three patients also developed a pouch fistula, 6 pre-pouch ileitis and 2 cuffitis. In none of the patients the diagnosis was changed to Crohn's disease after revision of the colectomy specimen by a senior pathologist.

Results: Prior to ADA, all 8 patients had been treated with antibiotics and infliximab (IFX), 2 with mesalazine, 7 with corticosteroids and 4 with immunomodulatory agents. Four patients – who all had received IFX prior to surgery – had to stop IFX after development of severe infusion reactions. The 4 other patients lost response after a median (range) of 17 (11–39) months on maintenance IFX. After 10 weeks on ADA therapy, 7/8 patients showed clinical response (5 partial and 2 complete). Median (IQR) C‑reactive protein levels dropped from 12 (5–44) to 5 (1–7) mg/L (p = 0.063) and median (IQR) mPDAI dropped from 9 (9–10) to 4 (4–9) points (p = 0.102). After a median (IQR) follow-up of 13 (7–32) months, 2 patients had a sustained clinical response, while 6 needed dose escalation to ADA 40 mg every week. At the end of follow-up, six patients were clinically still benefitting from ADA therapy. Two needed pouchectomy with permanent ileostomy after 8 and 15 months, respectively. One patient developed a catheter sepsis under ADA therapy.

Conclusions: ADA may be effective in IPAA patients with refractory pouchitis facing permanent ileostomy, but more data are required to conclude on its more generalized use.