P337. The switching therapy between infliximab and tacrolimus in steroid-refractory ulcerative colitis
K. Kimura1, K. Matsuoka1, J. Miyoshi1, S. Mizuno1, N. Inoue2, M. Naganuma3, T. Hisamatsu1, T. Yajima1, T. Kanai1, H. Ogata3, Y. Iwao2, T. Hibi1, 1Keio University School of Medicine, Department of Gastroenterology and Hepatology, Division of Internal Medicine, Tokyo, Japan, 2Keio University Hospital, Center for Preventive Medicine, Tokyo, Japan, 3Keio University School of Medicine, Center for Diagnostic and Therapeutic Endoscopy, Tokyo, Japan
Infliximab (IFX) and tacrolimus (Tac) were recently approved for use in refractory ulcerative colitis (UC) in Japan. There is, however, no consensus on which drug to use first for steroid-refractory UC patients. To clarify the positioning of each drug in the treatment of steroid-refractory UC, we retrospectively compared the therapeutic effect of IFX and Tac and also evaluated the therapeutic effect of switching between IFX and Tac.
A total of 80 UC patients treated with either IFX or Tac between July, 2009 and June, 2012 in our institute were retrospectively analyzed. We assessed disease activity at 3 months after starting treatment using Lichtiger index. A score of Lichtiger index less than or equal to 4 was defined as clinical remission. Colonoscopy was conducted at 3–6 months after starting treatment.
IFX and Tac were administered as a first-line therapy to 38 and 42 steroid-refractory patients, respectively. The average Lichtiger index score of 42 patients who received Tac was 11.6, and that of 38 patients who received IFX was 8.3, showing that Tac was used for more severe cases than IFX in our institute. Nineteen cases (45.2%) out of the 42 Tac treated cases achieved clinical remission at 3 months, while 19 cases (50.0%) out of 38 IFX treated cases achieved clinical remission. Thus, there was no significant difference on the clinical efficacy of IFX and Tac as a first-line treatment. We next analyzed 10 cases who received Tac after IFX had failed (IFX-Tac) and 17 cases who received IFX after Tac had failed (Tac-IFX). Only 2 case (20.0%) out of the 10 cases in the IFX-Tac group achieved clinical remission. Five cases (29.4%) out of the 17 cases in the Tac-IFX group achieved clinical remission. These findings suggest that the clinical efficacy of IFX and Tac is inferior when used as salvage therapy compared with these drugs used as the first-line treatment.
IFX and Tac are effective therapy in treating steroid-refractory UC. There was no difference on the clinical efficacy between the two agents, although Tac was used for more severe cases than IFX in our institute. Cases who did not respond to the first-line therapy responded less to the second-line treatment. Switching therapy must be considered carefully, because it does not have a satisfactory efficacy and may cause serious adverse events.