Immunodulation with tacrolimus (FK506): results of a prospective, open-label, non-controlled trial in patients with inflammatory bowel disease

Tacrolimus (FK506) is widely used in the organ transplant setting, but not in the treatment of IBD.

Objective: the aim of this study was to analyse the effectiveness of tacrolimus in specific clinical presentations of inflammatory bowel disease (IBD) in which recurrence is likely.

Patients and methods: inclusion criteria were: perianal Crohn's disease (PCD), CD in rectal stump, pouchitis and cuffitis with severely impaired function of the ileoanal pouch (IPAA), and proven refractoriness to other therapies. Clinical assessment: Hughes' classification (PCD); Oresland index (OI) in IPAA, endoscopy-biopsy and Quality of life (QoL) using the Spanish version of the IBDQ. Response was determined as complete (CP), partial (PR) or non-existent (NR). Tacrolimus was administered orally at a dose of 0.1 mg/kg/day (levels 5-15 .g/L).

Results: nineteen patients entered the study. Mean duration of treatment was 9.6 +/- 6.3 months. In PCD, CR was reported in 66% of cases and PR in 33%, with disappearance of inflammation, stenosis and ulcers. In patients with pouchitis and cuffitis,77% presented either CR or PR. The OI scores and QoL improved significantly after treatment (p<0.006 and p<0.002, respectively). Adverse effects were minor and controlled by regulating the dose.

Conclusion: oral administration of tacrolimus is easy to per-form and has few adverse effects when used to treat IBD in certain clinical presentations with a high likelihood of recurrence.