Introduction The management of moderately active ulcerative colitis (UC) refractory to standard medical treatment remains a challenge. NICE2recommends tacrolimus as one of the treatment options in refractory disease. Previously we reported our experience of tacrolimus in the first 17 patients, 7 of whom remained well. Here we provide our latest results.
Method Prospective data was collected from January 2010–January 2015 on all patients with UC who were refractory to, or intolerant of, standard therapy and were started on oral tacrolimus (Prograf). Initial dosing was 0.1 mg/kg/day in 2 divided doses; monitoring was undertaken following a local policy with blood testing and tacrolimus trough levels at week 2, 4 and at 3 monthly intervals thereafter. A target trough level between 5–20 ng/ml was maintained, with dosing adjusted accordingly. Clinical response was assessed by one consultant gastroenterologist (AWH) in clinic.
Results A total of 34 patients were treated with oral tacrolimus over the 5 year period. Of these, 17 (50%) demonstrated a clinical response, however only 10 (29%) of these tolerated the drug. Of the 10 patients who continued on tacrolimus the median duration of treatment was 7 months (range 2–60 months). Reasons for intolerance included renal impairment (n = 4), hypertension (n = 2), nausea and headache, which resulted in cessation of treatment. Therefore at the end of the 5 year period only 10 of 34 (29%) patients continued on treatment with tacrolimus. Of the 24 who were either non-responders or intolerant, 15 (63%) underwent colectomy and 9 received treatment with methotrexate, a biological agent or alicaforsen.
Conclusion This 5 year prospective audit using tacrolimus in patients with refractory UC in a general hospital outpatient setting has shown that with careful monitoring the drug may be used safely with a clinical response in about a third of patients for up to 60 months. Our findings are similar to those from tertiary centres where clinical remissions of 44%4and 20%5were reported. No long term adverse events to date have been reported in this group however close monitoring is essential.
Disclosure of interest None Declared.
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