Mucosal healing with oral tacrolimus is associated with favorable medium- and long-term prognosis in steroid-refractory/dependent ulcerative colitis patients

Background: Oral administration of tacrolimus is an effective remission induction therapy for steroid-refractory/dependent ulcerative colitis (UC). Aim: This study aimed to evaluate the short- as well as medium- and long-term effectiveness of tacrolimus therapy. Methods: The medical records of 51 patients treated with tacrolimus for UC at our hospital between July 2009 and December 2011 were reviewed retrospectively. Clinical remission and improvement were defined as a Lichtiger score of 4 or less and as a Lichtiger score of ≤. 10 and a reduction in the score of ≥. 3 compared with the baseline score, respectively. Endoscopic findings were evaluated based on the endoscopic activity index and Mayo endoscopic score. Results: The clinical effectiveness combining clinical remission and improvement was observed in 62.7% of the patients at 3. months. Thirty-six patients underwent colonoscopy at 3. months, and 12 (33.3%) and 10 patients (27.8%) showed Mayo endoscopic scores of 0 and 1, respectively. On Kaplan-Meier analysis, the overall percentage of event-free survivors, who did not require colectomy nor switching to other induction therapy such as infliximab, was 73.0% at 6. months, 49.9% at 1. year, and 37.8% at 2. years. Patients with a Mayo endoscopic score of 0-1 at 3. months showed significantly better medium- and long-term prognosis than those with a score of 2-3 (p<. 0.01). All adverse events, including infections in 2 patients, were reversible. Conclusions: Tacrolimus therapy was effective for inducing clinical and endoscopic remission of steroid-refractory/dependent UC. Endoscopic improvement was associated with favorable medium- and long-term prognosis.