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* = Presenting author

P503 Tacrolimus vs anti-tumour necrosis factor agents for moderately to severely active ulcerative colitis: a retrospective observational study

T. Yamamoto*, T. Shimoyama, S. Umegae, K. Matsumoto

Yokkaichi Hazu Medical Centre, Inflammatory Bowel Disease Centre, Yokkaichi, Japan

Background

The mechanisms of action of calcineurin inhibitors and anti-tumour necrosis factor (anti-TNF) are completely different. However, it is not easy to determine which drug, calcineurin inhibitor or anti-TNF agent, is more appropriate in a particular patient with refractory ulcerative colitis (UC). To our knowledge, there have been no comparative studies of tacrolimus vs anti-TNF agents (infliximab or adalimumab) to determine which treatment is safer and more effective in refractory UC. This study was to compare short-term safety and efficacy of tacrolimus vs anti-TNF agents for moderately to severely active UC.

Methods

One hundred patients with steroid-dependent/refractory, moderately to severely active, extensive UC were studied. Fifty patients were treated with oral tacrolimus (TAC group). The other 50 patients were treated with anti-TNF agents (anti-TNF group): 40 patients with infliximab and 10 with adalimumab. Primary endpoints were clinical response and remission rates, colectomy rate, and the incidence of adverse events during 12 weeks after the start of tacrolimus or anti-TNF therapy.

Results

Adverse events were observed in 6 patients (12%) in the TAC vs 9 (18%) in the anti-TNF groups (p = 0.58). At week 12, clinical remission was achieved in 20 patients (40%) in the TAC vs 14 (28%) in the anti-TNF groups (p = 0.29). Clinical response (including remission) was observed in 31 patients (62%) in the TAC vs 32 (64%) in the anti-TNF groups (p > 0.99). Further, 5 patients (10%) in the TAC and 8 (16%) in the anti-TNF groups required colectomy (p = 0.55). In a sub-group analysis restricted to severely active UC, the response rate was 50% (10/20 patients) in the TAC group, which was higher than 25% (4/16 patients) in the anti-TNF group (p = 0.24).

Conclusion

Both tacrolimus and anti-TNF agents appeared to be safe and effective in the management of moderately to severely active UC. For patients with acute severe UC, tacrolimus may be recommended. Anti-TNF agents may be suitable in less severe disease. However, randomised controlled trials are warranted to confirm these suggestions.