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P370. Short onset of ulcerative colitis predicts the response to cyclosporine (Neoral) as bridge therapy in steroid-refractory ulcerative colitis

M. Mastronardi1, P. Giorgio1, 1IRCCS “S. De Belllis”, Gastroenterology and Digestive Endoscopy, Castellana Grotte, Italy

Background

In the past 10 years, the Oxford regimen, based on the use of intravenous corticosteroids, has been modified by the introduction of cyclosporine (CyS) and infliximab (IFX) as treatment options of severe ulcerative colitis (UC). Long term prognosis, in CyS treated patients, is reported to be improved by the introduction of azathioprine (AZA) or mercaptopurine (6-MP) in association with oral CyS as bridge therapy. We report long-term follow-up results from an open-label study that assessed the efficacy and safety of oral CyS in steroid refractory-naïve patients with moderately to severely active UC.

Methods

17 patients (pts) (9 male, 8 female, aged 19–72 years), steroids and AZA/6-MP treatment naïve, received oral CyS as rescue therapy for acute UC, following 2–9 days of intravenous steroids (1 mg/kg/per day); pts were commenced on 5 mg/kg/per day of oral CyS (T0). After 2 weeks all the pts received AZA treatment (2 mg/kg/per day); all the pts followed their 5-ASA therapy (dose ranging 2.4–3.6 g/per day) and tapered steroids 5 mg/every week. The clinical assessment was evaluated with Mayo Scoring System for Assessment of UC Activity; clinical remission was defined as an inactive score and response was defined as an improvement of the activity score after 6 weeks of CyS treatment (T6).

Results

9/17 (52.9%) pts achieved clinical remission (R), 4 (23.5%) pts experienced a low clinical response (LR) and 4 (23.5%) pts were non responder (nR). The mean Mayo score at T0 was 9.1 points in RG and 8.87 points in nLR-nR; at T6 the mean Mayo score was 2.66 points in RG and 7.37 points in LR-nR. In R group the mean duration of the disease was 2.66 years vs 7.1 years in the LR-nR. In R group at the end of the follow-up (mean 13.8 m, range 7–28 m) 6/9 (66.7%) pts remain in clinical remission, 2/9 (22.2%) pts were in clinical remission in IFX therapy and 1/9 (11.2%) had colectomy. In LR-nR group at the end of follow-up (mean 14.7 m, range 2–31 m) 1/8 (12.5%) pt were in clinical remission, 4/8 (50%) pts remain in clinical remission with IFX therapy and 3/8 (37.5%) pts had colectomy. Experienced minor side effects 5/17 (30%) pts and 1/17 (5.8%) experienced EBV/CMV opportunistic infection successfully treated with valganciclovir.

Conclusion

A short onset of UC show a long-term benefit of CyS bridging therapy in severe refractory UC; in our experience 4/17 (76.4%) pts avoided colectomy; in R group (short onset of UC) only one patient had colectomy. None of our pts developed neurotoxicity, nephrotoxicity or anaphylaxis.