Rescue therapy with tacrolimus is effective in patients with severe and refractory inflammatory bowel disease
Version of Record online: 16 MAY 2003
Alimentary Pharmacology & Therapeutics
Volume 17, Issue 10, pages 1273–1281, 15th May 2003
How to Cite
Baumgart, D. C., Wiedenmann, B. and Dignass, A. U. (2003), Rescue therapy with tacrolimus is effective in patients with severe and refractory inflammatory bowel disease. Alimentary Pharmacology & Therapeutics, 17: 1273–1281. doi: 10.1046/j.1365-2036.2003.01534.x
- Issue online: 16 MAY 2003
- Version of Record online: 16 MAY 2003
- Accepted for publication 10 January 2003
Background : Oral tacrolimus, approved for the prophylaxis of organ rejection in liver or kidney transplants, has been reported to be effective in anecdotal cases of refractory inflammatory bowel disease.
Aim : To evaluate the usefulness of low-dose oral tacrolimus in refractory inflammatory bowel disease.
Methods: Thirty-one adult Caucasian patients with steroid-dependent (n = 15) or steroid-refractory (n = 16) inflammatory bowel disease (Crohn's disease, n = 6; ulcerative colitis, n = 23; pouchitis, n = 2) were enrolled. Tacrolimus (0.1 mg/kg body weight per day) was administered orally in 30 patients and initially intravenously in one patient (0.01 mg/kg body weight per day), aiming for serum trough levels of 4–6 ng/mL. The median treatment duration was 12 months (range, 1–137 months).
Results : Twenty-eight patients (90.3%) experienced a clinical and laboratory response and 20 (64.5%) went into remission. One ulcerative colitis patient and two Crohn's disease patients did not improve. Three ulcerative colitis patients (9.7%) were colectomized at 1, 12 and 24 months after tacrolimus initiation. In 19 of 23 patients (82.6%) taking steroids, steroids were reduced or discontinued. Side-effects included a temporary rise of creatinine (n = 3, 9.7%), tremor or paraesthesias (n = 3, 9.7%), hyperkalaemia (n = 1, 3.2%), hypertension (n = 1, 3.2%) and an opportunistic infection (n = 1, 3.2%).
Conclusion : Oral tacrolimus is safe and effective in refractory inflammatory bowel disease.