Published online Jun 14, 2021. doi: 10.3748/wjg.v27.i22.3109
Peer-review started: March 5, 2021
First decision: March 27, 2021
Revised: April 11, 2021
Accepted: May 22, 2021
Article in press: May 22, 2021
Published online: June 14, 2021
Oral tacrolimus is a therapeutic agent for moderate to severe steroid-dependent or resistant ulcerative colitis (UC), but remission induction is difficult, and it is necessary to treat the patient while considering the next treatment.
To examine serum albumin (Alb) level as a prognostic factor for the therapeutic effect of tacrolimus in clinical practice.
Forty-seven patients with UC treated with tacrolimus at our institution were divided into remission and failure groups (colectomy or switch to biologics), and the biological data at the start of observation and at weeks 1 and 2 were retrospectively examined. Kaplan-Meier and multivariate analyses were performed using Alb as a prognostic factor in UC treatment.
During the three months observed, 17 (36.2%) patients failed treatment with tacrolimus. A comparison between the failure and remission groups showed a significant difference only in Alb in week 2, and in the week 2/week 0 Alb ratio, which showed the rate of change in Alb. The cut-off value of the week 2/week 0 Alb ratio that predicted failure was 1, and its area under the curve was 0.751 (95%CI: 0.604-0.898). In the Kaplan-Meier analysis, a week 2/week 0 Alb ratio ≤ 1 had a significantly higher failure rate than that of > 1; Cox proportional hazard regression analysis also showed that a week 2/week 0 Alb ratio ≤ 1 was an independent prognostic factor for failure within 3 mo after the start of tacrolimus treatment.
A week 2/week 0 Alb ratio ≤ 1 predicts failure within 3 mo of tacrolimus administration for UC. High failure risk exists with week 2 Alb values ≤ 1 on admission.
Core Tip: The usefulness of serum albumin as a predictor of the therapeutic effect of oral tacrolimus for ulcerative colitis was investigated. Lower albumin levels in week 2 than in week 0 after achieving trough levels of tacrolimus were shown to increase risk for failure, including colectomy and switch to biologics, within 3 mo. In these cases, changes to other treatment options, including surgical total colectomy, should be considered as soon as possible.