Oral tacrolimus as maintenance therapy for refractory ulcerative colitis--an analysis of outcomes in two London tertiary centres.

BACKGROUND: The medical management of refractory ulcerative colitis (UC) remains a significant challenge. Two randomised controlled studies have demonstrated tacrolimus therapy is effective for the induction of remission of moderate to severe UC. However, the long term outcomes of UC patients treated with tacrolimus as maintenance therapy are not certain.

AIMS: This study aims to assess the efficacy of tacrolimus maintenance therapy for refractory UC.

METHODS: A retrospective review of patients with UC treated with tacrolimus at two London tertiary centres was performed. Clinical outcomes were assessed at six months, at the end of tacrolimus treatment, or at the last follow-up for patients continuing tacrolimus treatment. Modified Truelove-Witts score (mTW) and Mayo endoscopy subscores were calculated.

RESULTS: 25 patients with UC, treated with oral tacrolimus between 2005 and 2011, were identified. The median duration of tacrolimus treatment was 9 months (IQR 3.7-18.2 months). The median duration of follow-up was 27 months (range 3-66 months). At six months thirteen (52%) patients had achieved and maintained clinical response and eleven (44%) were in clinical remission. The mean mTW score decreased from 10+/-0.5 before therapy, to 5.8+/-0.8 (p≤0.001 95% CI 2.7-5.8) at cessation of treatment or last follow-up. Mayo endoscopy subscore decreased from 2.6+/-0.1 to 1.2+/-0.2 (p≤0.001 mean reduction 1.4, 95% CI 0.8-1.9). Eight patients (32%) subsequently underwent a colectomy within a mean time of 17 months (range 2-45 months).

CONCLUSION: Tacrolimus is effective for the maintenance of refractory UC and can deliver sustained improvement in mucosal inflammation.