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P219 Retrospective investigation of tacrolimus combined with an anti-TNFα antibody as remission induction therapy for refractory ulcerative colitis: efficacy, safety, and relapse rate

A. Ito*1, S. Murasugi1, N. Matsuo1, K. Tani1, T. Omori1, M. Itabashi1, K. Tokushige1

1Tokyo Women’s Medical University, Tokyo, Japan

Background

Combined therapy with tacrolimus (TAC) and an anti-TNFα antibody is used to induce remission in ulcerative colitis (UC) who have not responded to monotherapy with either drug. We evaluated the efficacy and safety of combined therapy, as well as the relapse rate.

Methods

The combined therapy was performed to induce remission in UC showing an inadequate response to monotherapy with TAC or an anti-TNFα antibody. The following items were assessed retrospectively: (1) clinical characteristics, (2) the remission induction rate, (3) the relapse rate, and (4) adverse events.

Results

Combined therapy induced remission in seven of the 12 patients (58.3%). There were no significant differences in clinical characteristics between the patients with and without the successful induction of remission. However, female patients tended to be more frequent in the remission group than in the non-remission group. The remission group also showed trends of a lower clinical activity index (CAI) on admission, and before combined therapy, and a lower total dose of prednisolone during hospitalisation. The 1-year relapse rate was 33.3%. Adverse events due to combined therapy included renal impairment (n = 2), tremor (n = 2), influenza (n = 1), and a positive cytomegalovirus antibody test (n = 3). None of these events were serious.

Conclusion

The combined therapy was effective in more than half of the patients with refractory UC who had not responded to mono therapy. Our findings suggest that combination therapy may be an option as a new third treatment for refractory UC.