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


CONCLUSIONS
Long-term administration of tacrolimus appears to be an effective and well-tolerated treatment for Japanese patients with refractory ulcerative colitis.
Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto, Japan.
S
S
Yamamoto
H
H
Nakase
S
S
Mikami
S
S
Inoue
T
T
Yoshino
Y
Y
Takeda
K
K
Kasahara
S
S
Ueno
N
N
Uza
H
H
Kitamura
H
H
Tamaki
M
M
Matsuura
K
K
Inui
T
T
Chiba
D000293:Adolescent; D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D012074:Remission Induction / Q000379:methods; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D016559:Tacrolimus