Ishida N, Miyazu T, Tamura S, Tani S, Yamade M, Iwaizumi M, Hamaya Y, Osawa S, Furuta T, Sugimoto K. Early serum albumin changes in patients with ulcerative colitis treated with tacrolimus will predict clinical outcome. World J Gastroenterol 2021; 27(22): 3109-3120 [PMID: 34168412 DOI: 10.3748/wjg.v27.i22.3109]
Corresponding Author of This Article
Ken Sugimoto, MD, PhD, Associate Professor, First Department of Medicine, Hamamatsu University of School of Medicine, 1-20-1 Handayama Higashi-ku Hamamatsu, Hamamatsu 431-3192, Japan. sugimken@hama-med.ac.jp
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Natsuki Ishida, Takahiro Miyazu, Satoshi Tamura, Shinya Tani, Mihoko Yamade, Yasushi Hamaya, Ken Sugimoto, First Department of Medicine, Hamamatsu University of School of Medicine, Hamamatsu 431-3192, Japan
Moriya Iwaizumi, Department of Laboratory Medicine, Hamamatsu University of School of Medicine, Hamamatsu 431-3192, Japan
Satoshi Osawa, Department of Endoscopic and Photodynamic Medicine, Hamamatsu University of School of Medicine, Hamamatsu 431-3192, Japan
Takahisa Furuta, Center for Clinical Research, Hamamatsu University of School of Medicine, Hamamatsu 43131, Japan
Author contributions: Ishida N contributed to this work; Ishida N and Sugimoto K designed the study; Sugimoto K, Miyazu T, Tamura S, and Tani S collected the data; Yamade M, Iwaizumi M, and Hamaya Y analyzed the data; Ishida N and Sugimoto K wrote the paper; Osawa S and Furuta T provided critical insights regarding paper preparation.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Hamamatsu University School of Medicine (No. 20-356).
Informed consent statement: Informed written consent was obtained from the patient for publication of this report and any accompanying images.
Conflict-of-interest statement: The authors received no financial support for the research, authorship, and/or publication of this article.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ken Sugimoto, MD, PhD, Associate Professor, First Department of Medicine, Hamamatsu University of School of Medicine, 1-20-1 Handayama Higashi-ku Hamamatsu, Hamamatsu 431-3192, Japan. sugimken@hama-med.ac.jp
Received: March 5, 2021 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 Processing time: 94 Days and 17.2 Hours
Abstract
BACKGROUND
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.
AIM
To examine serum albumin (Alb) level as a prognostic factor for the therapeutic effect of tacrolimus in clinical practice.
METHODS
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.
RESULTS
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.
CONCLUSION
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.
