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* = Presenting author

P528 Comparison of short-term and long-term outcomes between Anti-TNF-antibodies and tacrolimus for refractory ulcerative colitis patients

T. Ishida*1, T. Ueo1, R. Narita1, M. Motomura1, Y. Yanai1, K. Wada1, H. Honda1, S. Inoue1, K. Murakami2

1Oita Red Cross Hospital, Department of Gastroenterology, Oita, Japan, 2Oita University, Department of Gastroenterology, Oita, Japan

Background

Anti-TNF-antibodies (adalimumab [ADA] and infliximab [IFX]) and calcineurin inhibitors (tacrolimus [TAC]) play an important role in the treatment of moderate-to-severe ulcerative colitis (UC) unresponsive to conventional therapies. Difference of clinical effectiveness between these drugs is unclear. The aim of this study was to assess short-term and long-term outcomes of ADA, IFX, and TAC in refractory UC patients.

Methods

In this retrospective, observational single-centre study, patients with refractory UC who received ADA, IFX, or TAC treatment were evaluated: Group A (n = 156) treated with ADA (n = 46, 160/80 mg subcutaneously at weeks 0, 2, and then 40 mg every other week) or treated with IFX (n = 110, 5mg/kg intravenously at week 0, 2, 6, and then every 8 weeks); Group B (n = 75) treated with TAC (initially 0.05 mg/kg twice a day orally, then adjusted aiming for serum trough levels of 10–20 ng/mL). Thiopurine maintenance therapy was adapted to patients who responded to TAC, and then TAC therapy was ceased after 3 months. Primary endpoint was comparison of cumulative probability of continuing each therapy and colectomy-free rate during follow-up. Secondary endpoints were clinical remission or response at week 10 based on partial Mayo score and serious-adverse-event rates during follow-up.

Results

Anti-TNF-antibodies have higher rate of continuing each therapy and colectomy-free rates compared with TAC based on Kaplan–Meier survival analysis: 55.4% at 88 months for anti-TNF-antibodies; 19.4% at 96 months for TAC, p < 0.05 for anti-TNF-antibodies vs TAC; 90.8% at 88 months for anti-TNF-antibodies, 72.2 at 96 months for TAC, p < 0.05 for anti-TNF-antibodies vs TAC, respectively. No significant difference in rates of continuing therapy and colectomy-free was found between ADA and IFX treatment groups (53.1% at 28 months for ADA; 58.8% at 88 months for IFX, p = 0.08 for ADA vs IFX; 90.4% at 28 months for ADA, 90.9% at 88 months for IFX, p = 0.95 for ADA vs IFX, respectively). Rates of clinical remission and response at week 10 are similar between anti-TNF-antibodies and TAC (p = 0.09). ADA showed the lowest serious adverse event rates between the 3 agents: 1.9 evens/100 patient-years (E/100PY) for ADA, 9.1 E/100PY for IFX, and 51.9 E/100PY for TAC, (p < 0.05).

Conclusion

Although the retrospective uncontrolled design, single-centre analysis, and heterogeneity of patients studied limit our result, ADA and IFX seems to be more effective and safer than TAC is in long-term treatment for refractory UC in the real-life clinical setting.