Original Contribution
The American Journal of Gastroenterology (2006) 101, 1048–1056; doi:10.1111/j.1572-0241.2006.00524.x
Tacrolimus Is Safe and Effective in Patients with Severe Steroid-Refractory or Steroid-Dependent Inflammatory Bowel Disease—A Long-Term Follow-Up
Daniel C Baumgart MD, PhD, Jan P Pintoffl MD, Andreas Sturm MD, PhD, Bertram Wiedenmann MD, PhD and Axel U Dignass MD, PhD
Department of Medicine, Division of Hepatology and Gastroenterology, Charité Medical Center, Virchow Hospital, Medical School of the Humboldt-University of Berlin, Germany
Correspondence: Axel U Dignass, MD, PhD, Department of Medicine, I, Markus-kronkenhaus, Academic Teaching Hospital of the Johann-Wolfgang-Goethe-Universität Frankfurt, Wilhelm-Epstein-Str. 2, D-60431 Frankfurt/Main, Germany.
Received 26 June 2005; Accepted 28 November 2005.
Abstract
OBJECTIVE:
We and others have reported the use of tacrolimus in refractory inflammatory bowel disease (IBD). Little is known about its long-term efficacy and safety.
METHODS:
In this retrospective, observational single center study the charts of 53 adult patients with steroid-dependent (n = 18) or steroid-refractory (n = 35) IBD, Crohn's disease (CD) (n = 11), ulcerative colitis (UC) (n = 40), or pouchitis (PC) (n = 2) were reviewed. Tacrolimus (0.1 mg/kg body weight per day) was administered orally in all and initially intravenously in 2 patients (0.01 mg/kg body weight per day), aiming for serum trough levels of 4–8 ng/mL. Forty-one of 53 (77.1%) patients were receiving concomitant azathioprine. The mean treatment duration was 25.2 
4.6 SD months (0.43–164 months). Patients were followed for a mean of 39 4.1 SD months (5–164 months). Response was evaluated using a modified clinical activity index (M-CAI).
RESULTS:
Thirty-one UC (78%), 10 CD (90.1%), and both PC (100%) patients experienced an immediate clinical response or went into remission at 30 days. A statistically significant drop on the M-CAI was documented for UC and CD patients. Nine UC patients (22.5%) underwent colectomy between 1.6 and 41.3 months following initiation. Mean colectomy-free survival was 104.8 15.5 (95% CI 74.4–135.2) months (limited to 164.4 months). Cumulative colectomy-free survival was estimated 56.5% at 43.8 months. Steroids were reduced or discontinued in 40 of 45 UC and CD patients (90%) taking steroids. Side effects included a temporary rise of creatinine (n = 4, 7.6%), tremor or paresthesias (n = 5, 9.4%), hyperkalemia (n = 1, 1.9%), hypertension (n = 1, 1.9%), and opportunistic infections (n = 2, 3.8%).
CONCLUSION:
Long-term tacrolimus therapy appears safe and effective in refractory IBD.
