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P539. Clinical response and mucosal healing after infliximab rescue therapy for patients with severe ulcerative colitis refractory to systemic corticosteroids

M. Fortuna1, R. Montanari1, A. Geccherle1, G. Ruffo2, M. Chiaramonte1, 1Sacro Cuore Don Calabria Negrar Hospital, Multispecialistic Centre for Recto-Perineal Diseases (IBD Unit), Department of Gastroenterology, Negrar (VR), Italy, 2Sacro Cuore Don Calabria Negrar Hospital, Department of General Surgery, Negrar - VR, Italy

Background

Infliximab (IFX) has been shown to be effective as rescue therapy (tp) in patients (pts) with severe ulcerative colitis (UC) refractory to intravenous (i.v.) steroids.

However little is known about long-term benefits and predictive factors of clinical outcome. Furthermore, it's still debated, whether mucosal healing (MH) is achievable in these pts. The aim of this single centre open-lable study is to provide further data on long-term effect of IFX in pts treated as rescue tp, in terms of sustained clinical response and MH.

Methods

From January 2009 to December 2010, 14 in-pts with severe UC (according to Truelove and Witts criteria) were recruited at the Gastroenterology Department of Negrar Hospital (Verona, Italy). Age, gender, extent of UC and duration of disease were recorded.

All were treated with i.v. methylprednisolone 1 mg/kg: at day seven 9 pts (64.2%) were steroid refractory. One underwent urgent colectomy and 8 were treated with IFX (5 mg/kg for induction period and subsequently for 52 weeks).

After 1 year we performed colonoscopy to assess MH. The endoscopies were scored using the Mayo Endoscopic Score. We defined MH as a subscore of 0 or 1.

Results

After IFX induction period 1/8 pts (12.5%) failed to respond and underwent elective colectomy.

Seven of 8 pts (87.5%) received 1 year IFX maintenance tp. After 12 months 1/7 failed to respond and underwent elective colectomy.

Six pts (71.4%), 5 males, age 25–51 years, 4 pancolitis, 2 left-sided colitis, had sustained clinical response after 1 year IFX tp. Out of them 5 pts had recently diagnosed CU (mean disease duration 16.8 months) and started IFX as a first line tp after steroid refractoriness. One of 6 pts had partial clinical response. After 1 year only 2/6 pts (33.3%) achieved MH. 3/6 had a Mayo Score of 2, 1/6 a Mayo Score of 3. The colectomy rate after 1 year IFX tp was 14.3%.

Not responders pts (2 with colectomy and 1 with partial response at 1 year), age 37–64 years, had long lasting pancolitis (over 10 years) and a Mayo Score of 3.

Conclusion

Our study confirms the efficacy of IFX as rescue therapy in pts refractory to i.v. steroids. 85.7% of pts, after 1 year of maintenance tp, avoided colectomy. Long lasting disease, older age and extent of UC were associated with a less favorable outcome.

Clinical response in severe UC did not predict MH: 33.3% of pts with a sustained clinical response achieved MH.

It seems that early use of IFX can be associated with improved long-term clinical outcomes in severe UC, however further studies are needed.