Revista espanola de enfermedades digestivas · 2003
Immunodulation with tacrolimus (FK506): results of a prospective, open-label, non-controlled trial in patients with inflammatory bowel disease.
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de Oca J, Vilar L, Castellote J, Sánchez Santos R, Parés D, Biondo S, Osorio A, del Rio C, Jaurrieta E, Martí Ragué J
Аннотация
UNLABELLED: 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.
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.