1041 Intravenous Cyclosporin in Severe Steroid-Refractory Ulcerative Colitis: Long-Term Follow-Up

Abstract

OBJECTIVE:Intravenous (IV) cyclosporin (CSA) is an alternative to surgery for patients (pts) with severe ulcerative colitis (UC). We previously published open-label 5-year data, and now present long-term follow-up on the same pts. METHODS:The original 42 pts with IV steroid-refractory severe UC treated with IV CSA from 1991 to 1995 were identified using the University of Chicago IBD registry. Additional information on clinical course, medication use, surgeries and adverse events were collected from electronic and paper charts. Pts who initially received CSA but eventually went to colectomy were referred to as “surgical” pts; those who have avoided colectomy were referred to as “non-surgical” pts. RESULTS:The mean duration of IV CSA was 10.3 days (+/5.4), at a mean CSA level of 379 (+/-126) ng/ mL (HLPC). Initial response was seen in 36 of 42 pts (86%); 11 patients subsequently underwent colectomy at a median of 18 weeks (range 3-79). Twenty-five (60%) of the original 42 pts avoided colectomy in the short-term at a mean follow-up of 23 months. Nineteen of these 25 (76%) pts have continued to avoid colectomy at a median of 81 months. Overall, 45% of the initial pts remained colectomy-free at a mean 75 months (+/44.7). Surgery was avoided in 56% of pts receiving 6-mercaptopurine (6MP) or azathioprine (aza) vs. 27% of those who did not (p=0.014). The rate of 6MP/aza use was higher in nonsurgical pts (79% vs. 40%, p= 0.08). Life analysis predicted 15.5 year “noncolectomy survival” rates of 39% overall; rates were highest in those with 6MP/aza (49% vs. 17%, p= 0.036; Figure 1). Six of 8 pts who repeated IV CSA subsequently underwent colectomy at a median 8.3 months (range 0.1-37) after last IV CSA, despite 6MP/aza in all (mean duration 38.27 months +/31.05). CONCLUSION:Intravenous cyclosporin was successful in avoiding surgery in 45% of severe, IV steroidrefractory UC pts; predicted long-term success is highest in those who received 6MP/aza.