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P260. Infliximab as rescue therapy for patients with severe ulcerative colitis refractory to systemic corticosteroids: A single centre open-label study

M. Fortuna1, R. Montanari1, A. Geccherle1, A. Sartori2, G. Ruffo2, M. Chiaramonte1

1Ospedale Sacro Cuore Don Calabria, Gastroenterology, Negrar VR, Italy; 2Ospedale Sacro Cuore Don Calabria, General Surgery, Negrar VR, Italy

Background: Infliximab (IFX) is effective for induction and maintenance of clinical remission in patients with moderate to severe ulcerative colitis (UC). Data concerning its proven efficacy as a rescue therapy in the severe forms of the disease refractory to intravenous (i.v.) steroids are lacking.

We present the results of a single centre open-label study, that has evaluated short-and long-term clinical responses and colectomy rates in severe i.v. steroid-refractory UC treated with biological therapy.

Methods: From January 2009 to December 2010 all hospitalized patients at the Gastroenterology Department of Negrar Hospital (Verona-Italy) with severe UC, according to Truelove and Witts criteria, were recruited.

All patients received metilprednisolone 1 mg/Kg i.v. for 7 days. Infliximab (5 mg/Kg at 0, 2 and 6 weeks) was used as rescue therapy in steroid-refractory patients.

The success of biological therapy was based on a decrease in disease activity. Patients with lack of response to IFX or steroid-refractory forms of disease considered too severe to initiate an IFX course underwent colectomy. Patients who responded to induction were evaluated after one year of maintenance therapy with IFX.

Results: In the considered period 14 patients met our criteria of recruitment (10 males, 4 females, age 24–70 years).

8 of them had pancolitis and 6 had left-sided colitis. After 7 days on i.v. steroids, 5/14 (35.7%) patients showed a clinical response, while 9/14 (64.2%) were considered steroid-refractory. Of these, one underwent urgent colectomy and 8 were treated with IFX. 1/8 (12.5%) patient failed to respond to induction therapy and underwent elective colectomy. 7/8 (87.5%) patients had a satisfactory clinical response after the induction period of biological treatment.

After one year of maintenance therapy with IFX, 5/7 patients showed sustained clinical response, whereas 1/7 had to stop the treatment after 9 months for Aspergillus systemic infection and is now on azathioprine.

1/7 failed to respond and underwent elective colectomy after 12 months of IFX therapy.

The colectomy rate after one year of biological treatment was therefore 14.3%.

Conclusions: Our study confirms the efficacy of Infliximab as an alternative to colectomy in patients refractory to i.v. steroids. After one year of maintenance therapy with Infliximab, 85.7% of patients who showed a response to induction treatment avoided colectomy. Both colectomies, in the patients with lack of clinical response, were performed on an elective regime.