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* = Presenting author

P397 Efficacy and safety of sequential rescue therapy with infliximab and tacrolimus in patients with corticosteroid-refractory ulcerative colitis

K. Matsuoka*, E. Saito, T. Fujii, K. Takenaka, F. Iwamoto, M. Kimura, M. Nagahori, K. Ohtsuka, M. Watanabe

Tokyo Medical and Dental University, Department of Gastroenterology and Hepatology, Tokyo, Japan

Background

Rescue therapy with either infliximab or tacrolimus is an effective option in patients with corticosteroid-refractory ulcerative colitis (UC). When the patient fails to either of these drugs, colectomy is usually recommended. However, second-line rescue therapy with either infliximab or tacrolimus can be an alternate. This study aimed to examine the efficacy and safety of sequential rescue therapy with infliximab and tacrolimus.

Methods

We retrospectively reviewed medical charts of 49 patients who received sequential rescue therapy with tacrolimus and infliximab between 2009 and 2014 in our institution. The interval between the treatments was within 8 weeks. The primary endpoints were rates of clinical remission at 3 months, defined with a partial Mayo score of 2 or less with all items of 1 or less, and rates of event-free survival, defined with no requirement of either other remission-induction therapy or colectomy. Adverse events were also evaluated.

Results

In the study, 20 patients (13 [65.0%] males; median age: 39.0 years) received tacrolimus after failing infliximab (IFX-Tac), and 29 patients (12 [41.4%] males; median age 39.0 years) received infliximab after failing tacrolimus (Tac-IFX). The mean treatment periods of the first-line rescue therapy were 59.5 days and 54.5 days in the IFX-Tac and Tac-IFX groups, respectively. The mean partial Mayo scores before the 2nd-line rescue therapy were 6.3 vs 5.8 in the IFX-Tac and Tac-IFX groups (p = 0.37). The rates of clinical remission at 3 months were 30.0% (6/20) in the IFX-Tac group and 34.5% (10/29) in the IFX-Tac group (p = 0.72). The event-free survival rates were 47.5% at 1 year, and 47.5% at 2 years in the IFX-Tac group; 46.3% at 1 year, and 46.3% at 2 years in the Tac-IFX group (p = 0.96). No serious adverse events were observed during the study period.

Conclusion

Second-line rescue therapy with either infliximab or tacrolimus is an effective and safe option in patients failing first-line rescue therapy.