P536 Long term efficacy and safety for Sequential Rescue Treatments in patents with steroid refractory Ulcerative Colitis - Two years follow up data
M. Protic*1, P. Frei2, C. Manser3, T. Knezevic1, C. Mottet4, P. Juillerat5, S. Markovic1, C. Beglinger6, N. Jojic1, S. Vavricka7, G. Rogler3, F. Seibold8
1University Hospital Zvezdara, Department of Gastroenterology, Belgrade, Serbia, 2See Spital, Department of Gastroenterology, Zürich, Switzerland, 3University Hospital Zurich, Department of Gastroenterology, Zurich, Switzerland, 4Hospital Neuchâtel, Department of Gastroenterology, Neuchâtel, Switzerland, 5University Hospital Bern, Gastroenterology and Hepatology, Bern, Switzerland, 6University Hospital Basel , Division of Gastroenterology & Hepatology, Basel, Switzerland, 7Stadtspital Triemli, Department of Gastroenterology, Zürich, Switzerland, 8Tiefenau Spital, Department of Gastroenterology, Bern, Switzerland
Although medical management of moderate to severe steroid refractory ulcerative colitis (UC) still remains a challenge, medical interventions with sequential rescue therapies in recent years showed encouraging results. Even though sequential use of rescue treatments is potentially risky, many patients like to have additional rescue therapies to avoid colectomy.
AIM: To evaluate remission, response and adverse event rates in the cohort treated with one or sequential rescue therapy over two-year period.
The outcome after two years follow up of the cohort of 108 patients with steroid-refractory moderate to severe ulcerative colitis treated with a single or sequential rescue treatments with Infliximab (5mg/kg intravenously at week 0, 2, 6 and then every 8 weeks), Cyclosporine (iv CsA 2mg/kg/daily and then oral CsA 5mg/kg/daily) or Tacrolimus (0.05mg/kg divided in 2 doses, aiming for serum trough levels of 7-12 ng/mL) was retrospectively evaluated. The primary endpoint was 2 year response and remission rate; the secondary endpoint was the late adverse event (AE) rate in 2nd year of follow up.
Out of 108 patients in the primary cohort, 98 patients (90%) were followed for at least 2 years; 69/76 patients treated with single, 23/26 patients with double and all 6 patients on triple rescue treatment. 10 patients were lost to follow up. 2 years after the induction with single or sequential rescue therapies 73% (72/98) still have response. Corticosteroid free remission rate in the whole cohort slightly decreased from 39 % (42/108) after first year to 29% (28/98) [p=0.118 OR 1.59 CI 0.89 - 2.86]. In the selected group of patients treated with sequential treatments (double or triple) steroid free remission rate insignificantly decreased from 22% (7/32) to 17% (5/29) (p= 0.649 OR 1.35 CI 0.38-4.83). The AE rate in the 2nd year of follow up was 14% (14/98). No significant difference of the AE rates between the patients treated with single -10% (7/69) or sequential rescue treatments -24% (7/29) (p=0.071 OR 2.81 CI 0.88 - 8.95) was identified.
According to our results, sequential rescue therapies regime showed prolonged response with mild frequency of the late AEs in the group of patients with steroid refractory UC, 2 years after the induction rescue therapies. Still, further follow up and adverse effects analysis will be necessary for the estimation of the real impact of sequential rescue therapies in UC.