Long-term effect of tacrolimus therapy in patients with refractory ulcerative colitis.

Abstract

BACKGROUND:

Little is known about long-term outcome of tacrolimus therapy for ulcerative colitis. Aim To evaluate long-term efficacy and safety of tacrolimus in Japanese patients with refractory ulcerative colitis.

METHODS:

Twenty-seven patients with UC refractory to conventional therapy were administered tacrolimus with trough whole-blood levels of 10-15 ng/mL to induce remission and 5-10 ng/mL to maintain remission. Median treatment duration was 11 months (1-39 months) and median follow-up duration was 17 months (2-65 months). Evaluation of the clinical response was based on a modified Truelove-Witts severity index (MTWSI).

RESULTS:

Tacrolimus produced a clinical response in 21 patients (77.8%), and remission was achieved in 19 of these 21 (70.4%) within 30 days. Overall cumulative colectomy-free survival was estimated as 62.3% at 65 months. In 18 of 19 patients treated with corticosteroids at the initiation of tacrolimus therapy, corticosteroids were discontinued or tapered. Adverse events were tremor (25.9%), renal function impairment (18.5%), infectious disease (14.8%), hot flashes (11.1%), hyperkalaemia (7.4%), headache (7.4%), epigastralgia (7.4%) and nausea (3.7%). No mortality occurred.

CONCLUSION:

Long-term administration of tacrolimus appears to be an effective and well-tolerated treatment for Japanese patients with refractory ulcerative colitis.

• Authors: S Yamamoto, H Nakase, S Mikami, S Inoue, T Yoshino, Y Takeda, K Kasahara, S Ueno, N Uza, H Kitamura, H Tamaki, M Matsuura, K Inui, T Chiba
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 28 Issue 5 Pg. 589-97 (Sep 01 2008) ISSN: 1365-2036 [Electronic] England
• PMID: 18549460 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Immunosuppressive Agents
• Tacrolimus

Topics

• Adolescent
• Adult
• Aged
• Colitis, Ulcerative (drug therapy)
• Dose-Response Relationship, Drug
• Female
• Follow-Up Studies
• Humans
• Immunosuppressive Agents (administration & dosage, adverse effects)
• Long-Term Care
• Male
• Middle Aged
• Remission Induction (methods)
• Tacrolimus (administration & dosage, adverse effects)
• Treatment Outcome