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P474 Assessing the position of systemic tacrolimus in the treatment of inflammatory bowel disease: systematic review and meta-analysis

M. Lie*, J. Kreijne, B. Hansen, J. van der Woude

Erasmus MC, Gastroenterology and Hepatology, Rotterdam, Netherlands


Medical therapy for both Crohn’s disease (CD) and ulcerative colitis (UC) shows great overlap and occurs according to a treatment pyramid. Located at the bottom of the pyramid are drugs with the lowest costs, efficacy and fewest side effects, whereas the top of the pyramid consists of biological drugs, which are highly effective but come at high monetary costs. The middle of the pyramid consists of immunomodulators, mainly thiopurines and methotrexate (MTX). A significant gap in costs and efficacy exists between immunomodulators and biologicals. Interestingly, only thiopurines and MTX are present in the current treatment pyramid. Tacrolimus has shown to be effective in treating CD and UC. It might be necessary to change the current pyramid with the introduction of tacrolimus as an alternative immunomodulator. As such, the objective of this study was to systematically review the literature for the efficacy and tolerability of systemic tacrolimus in CD and UC patients.


An electronic search for relevant studies was performed in Embase, Medline, Medline OvidSP, Cochrane Central Register of Controlled Trials, Web of Science, and PubMed. Reference lists were also reviewed. Randomised controlled trials were included if they enrolled ≥ 10 patients, had a treatment duration of ≥ 1 week, and reported ≥ 1 of the primary outcomes. Outcomes included the clinical response and remission rates and the maintained clinical response and remission rates. We calculated relative risks (RR) and 95% confidence intervals (CI). Secondary outcomes were reported adverse events.


Three randomised controlled trials (n = 170) were included. Meta-analysis of 2 UC studies found that tacrolimus was significantly superior to placebo for induction of clinical response (Figure 1; RR 4.21; 95% CI 1.91–9.28). There was no significant difference in clinical remission (RR 3.54; 95% CI 0.66–18.83), probably because of low event rates. When assessing only UC patients treated towards high induction trough levels of 10 to 15 ng/mL, the results did not differ significantly. Serious adverse events occurred in 3.1% of all tacrolimus treated patients in the controlled trials.

Table 1 Response, any trough level vs placebo


Although limited, there is evidence suggesting that tacrolimus is an effective induction and maintenance therapy for CD and UC. Serious adverse effects are rare. These results warrant further studies into the efficacy of systemic tacrolimus and its position in the IBD treatment pyramid.