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* = Presenting author

P541 Cyclosporine therapy is effective in acute severe steroid-refractory ulcerative colitis

R. Iliaz1, S. Evirgen1, F. Akyuz1, B. Cavus1, B. Pinarbasi2, C. Karaca1, K. Demir1, F. Besisik1, S. Kaymakoglu*1

1Istanbul University, Department of Gastroenterology, Istanbul, Turkey, 2Liv Hospital, Department of Gastroenterology, Istanbul, Turkey

Background

Cyclosporine (Cyc) is one of the rescue treatments to induce remission in acute severe corticosteroid (CS) refractory ulcerative colitis (UC). We aimed to evaluate the long-term efficacy and safety of Cyc therapy in severe UC patients.

Methods

We retrospectively evaluated our patients with severe (according to Truelove–Witts activity index) UC refractory to CS treatment. CS refractoriness was defined as to continue of active disease despite methylprednisolone over a period of 7–14 days. Presence of clinical response and remission was assessed at week 1, month 1, month 6, and month 12 according to Lichtiger index. Cyc was given as continuous intravenous infusion (4 mg/kg/day for 7–10 days) followed by 8 mg/kg/day orally. A trough-C0 level of 150–250 ng/mL was targeted and the treatment was planned to continue for at least 6 months. CS treatment was tapered and discontinued over a period of 6–8 weeks in those responder patients. All patients received concomitant thiopurines. Unresponsive to Cyc or relapsing patients were referred for colectomy.

Results

In total, 40 (87.5% pancolitis) acute severe UC unresponsive to CS patients were enrolled in the study. All patients received Cyc for 132 ± 78 (7–2 270) days. The mean age of patients (27 males), and median disease duration were 34.7 ± 12.7 years and 49.3 (2–204) months, respectively. Clinical response was obtained at seventh day in 75% (n = 30) of them. The clinical response rates of the first and sixth months were 62.5% and 67.5%, respectively. Total 16/40 (40%) patients underwent colectomy within 1 year. Of colectomised patients, 9 were primary nonresponders, and 7 were relapsers (6 patients in the first 6 months after discontinuation of cyclosporine therapy and 1 patient in third month of Cyc therapy). In 1 patient who relapsed (in the third month) on Cyc treatment, remission was obtained by infliximab. In addition, 76% of patients (23/30) who were responders at the seventh day of the therapy were in steroid-free remission at the end of the first year. AZA naïve and experienced patients before Cyc had similar remission rates during the first year. Further, 7 (17.5%) patients had some adverse events (hypertension, HSV conjunctivitis, gingiva hyperplasia, hypertrichosis, disseminated VZV, urticaria, and convulsion). Cyc was stopped because of disseminated VZV infection in only 1 patient.

Conclusion

Clinical response was observed in 75% of patients during the first week of Cyc treatment. More than half of the patients were in remission, and the colectomy rate was 40% at the end of the first year. Our findings suggest that Cyc treatment might be successfully and safely used in acute severe steroid-refractory UC patients.