Portal de Periódicos da CAPES

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

2008; Wiley; Volume: 28; Issue: 5 Linguagem: Inglês

10.1111/j.1365-2036.2008.03764.x

1365-2036

Shigehiro Yamamoto, Hiroshi Nakase, Shuji Mikami, Satoko Inoue, Takayuki Yoshino, Yasuhiro Takeda, Katsuhiro Kasahara, Satoshi Ueno, Norimitsu Uza, Hiroshi Kitamura, Hiroyuki Tamaki, Minoru Matsuura, Ken‐ichi Inui, T. CHIBA,

Mycobacterium research and diagnosis

Summary 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.