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Tacrolimus Salvage in Anti–Tumor Necrosis Factor Antibody Treatment-Refractory Crohn’s Disease

Gerich, Mark E. MD*; Pardi, Darrell S. MD; Bruining, David H. MD; Kammer, Patricia P. CCRP; Becker, Brenda D.; Tremaine, William T. MD

doi: 10.1097/MIB.0b013e318280b154
Original Clinical Article

Background: Several small retrospective studies have reported encouraging response rates in patients with Crohn’s disease (CD) treated with tacrolimus.

Methods: We conducted a retrospective study of the use of oral tacrolimus for severe CD refractory to anti–tumor necrosis factor agents. Response was defined as a clinician’s assessment of improvement after at least 7 days of treatment of one or more of the following: bowel movement frequency, fistula output, rectal bleeding, abdominal pain, extraintestinal manifestations, or well-being. Remission required all of the following: <3 stools per day, no bleeding, abdominal pain or extraintestinal manifestations, and increased well-being.

Results: Twenty-four eligible patients were treated with tacrolimus for a median of 4 months. Approximately 37% were steroid dependent or steroid refractory. Response and steroid-free remission rates were 67% and 21%, respectively, and lasted for a median of 4 months. Approximately 42% of patients were able to stop steroids and 54% of patients ultimately required surgery within a median of 10 months after starting tacrolimus. Patients with mean tacrolimus trough levels of 10 to 15 ng/mL had the highest rates of response (86%) and remission (57%). Surgery seemed to be postponed in this group compared with others. An adverse event occurred in 75% of patients. Eight of these events (33%) required dose reduction and 6 (25%) led to treatment discontinuation. There were no irreversible side effects or deaths attributable to tacrolimus over a median follow-up of 56 months.

Conclusions: Oral tacrolimus seems to be safe and effective in some patients with severe CD refractory to anti–tumor necrosis factor therapy, particularly at a mean trough level of 10 to 15 ng/mL.

Article first published online 20 March 2013

*Division of Gastroenterology and Hepatology, University of Colorado Denver, Aurora, Colorado; and

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.

Reprints: Mark Gerich, MD, Division of Gastroenterology and Hepatology, University of Colorado Denver, 12631 East 17th Avenue, MS B158, Aurora, CO 80045 (e-mail:

The authors have no conflicts of interest to disclose.

Received August 15, 2012

Accepted August 22, 2012

© Crohn's & Colitis Foundation of America, Inc.
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