Long-term effect of tacrolimus therapy in patients with refractory ulcerative colitis

BACKGROUND: Little is known about long‐term outcome of tacrolimus therapy for ulcerative colitis. Aim To evaluate long‐term efficacy and safety of tacrolimus in Japanese patients with refractory ulcerative colitis. METHODS: Twenty‐seven patients with UC refractory to conventional therapy were administered tacrolimus with trough whole‐blood levels of 10‐15 ng/mL to induce remission and 5‐10 ng/mL to maintain remission. Median treatment duration was 11 months (1‐39 months) and median follow‐up duration was 17 months (2‐65 months). Evaluation of the clinical response was based on a modified Truelove‐Witts severity index (MTWSI). RESULTS: Tacrolimus produced a clinical response in 21 patients (77.8%), and remission was achieved in 19 of these 21 (70.4%) within 30 days. Overall cumulative colectomy‐free survival was estimated as 62.3% at 65 months. In 18 of 19 patients treated with corticosteroids at the initiation of tacrolimus therapy, corticosteroids were discontinued or tapered. Adverse events were tremor (25.9%), renal function impairment (18.5%), infectious disease (14.8%), hot flashes (11.1%), hyperkalaemia (7.4%), headache (7.4%), epigastralgia (7.4%) and nausea (3.7%). No mortality occurred. CONCLUSION: Long‐term administration of tacrolimus appears to be an effective and well‐tolerated treatment for Japanese patients with refractory ulcerative colitis.