Retrospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Jan 8, 2017; 9(1): 57-63
Published online Jan 8, 2017. doi: 10.4254/wjh.v9.i1.57
Clinical usefulness of ursodeoxycholic acid for Japanese patients with autoimmune hepatitis
Yuichi Torisu, Masanori Nakano, Keiko Takano, Ryo Nakagawa, Chisato Saeki, Atsushi Hokari, Tomohisa Ishikawa, Masayuki Saruta, Mikio Zeniya
Yuichi Torisu, Masanori Nakano, Keiko Takano, Ryo Nakagawa, Chisato Saeki, Atsushi Hokari, Tomohisa Ishikawa, Masayuki Saruta, Division of Gastroenterology and Hepatology, Department of Internal Medicine, the Jikei University School of Medicine, Tokyo 105-8461, Japan
Yuichi Torisu, Masanori Nakano, Department of Internal Medicine, Fuji City General Hospital, Shizuoka 417-8567, Japan
Mikio Zeniya, Department of Internal Medicine, Sanno Medical Center, Tokyo 107-0052, Japan
Author contributions: Torisu Y and Zeniya M designed the research; Torisu Y collected and analyzed the data; Nakano M, Takano K, Nakagawa R, Saeki C, Hokari A, Ishikawa T and Saruta M revised the manuscript for important intellectual content; Torisu Y and Zeniya M wrote the paper; all authors have read and approved the final version to be published.
Institutional review board statement: The study was reviewed and approved by the Jikei University School of Medicine Institutional Review Board; IRB Protocol No: 26-321(7827).
Informed consent statement: Written, informed consent for participation in this study was not obtained from the patients, because this study did not report on a clinical trial and the data were retrospective in nature and analyzed anonymously.
Conflict-of-interest statement: We have no financial relationships to disclose.
Data sharing statement: No additional data are available.
Open-Access: 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/
Correspondence to: Yuichi Torisu, MD, Division of Gastroenterology and Hepatology, Department of Internal Medicine, the Jikei University School of Medicine, 3-25-8 Nishishinbashi, Minato-ku, Tokyo 105-8461, Japan. torisu@yb4.so-net.ne.jp
Telephone: +81-03-34331111 Fax: +81-03-34350569
Received: July 10, 2016
Peer-review started: July 14, 2016
First decision: September 12, 2016
Revised: September 25, 2016
Accepted: November 21, 2016
Article in press: November 22, 2016
Published online: January 8, 2017
Processing time: 180 Days and 16.7 Hours
Abstract
AIM

To evaluate the therapeutic effects of ursodeoxycholic acid (UDCA) on autoimmune hepatitis (AIH).

METHODS

A total 136 patients who were diagnosed with AIH were included in our study. All of the patients underwent a liver biopsy, and had at least a probable diagnosis on the basis of either the revised scoring system or the simplified scores. Initial treatment included UDCA monotherapy (Group U, n = 48) and prednisolone (PSL) monotherapy (Group P, n = 88). Group U was further classified into two subgroups according to the effect of UDCA: Patients who had achieved remission induction with UDCA monotherapy and showed no sign of relapse (Subgroup U1, n = 34) and patients who additionally received PSL during follow-up (Subgroup U2, n = 14). We compared the clinical and histological findings between each groups, and investigated factors contributing to the response to UDCA monotherapy.

RESULTS

In Group U, 34 patients (71%) achieved and maintained remission over 49 (range: 8-90) mo (Subgroup U1) and 14 patients (29%) additionally received PSL (Subgroup U2) during follow-up. Two patients in Subgroup U2 achieved remission induction once but additionally required PSL administration because of relapse (15 and 35 mo after the start of treatment). The remaining 12 patients in Subgroup U2 failed to achieve remission induction during follow-up, and PSL was added during 7 (range: 2-18) mo. Compared with Subgroup U2, Subgroup U1 had significantly lower alanine aminotransferase (ALT) levels at onset (124 IU/L vs 262 IU/L, P = 0.023) and a significantly higher proportion of patients with mild inflammation (A1) on histological examination (70.6% vs 35.7%, P = 0.025). When multivariate analysis was performed to identify factors contributing to the response to UDCA monotherapy, only a serum ALT level of 200 IU/L or lower was found to be associated with a significant difference (P = 0.013).

CONCLUSION

To prevent adverse events related to corticosteroids, UDCA monotherapy for AIH needs to be considered in patients with a serum ALT level of 200 IU/L or lower.

Keywords: Autoimmune hepatitis; Japanese patients; Adverse events; Corticosteroids; Ursodeoxycholic acid

Core tip: Autoimmune hepatitis (AIH) is generally responsive to immunosuppressive treatment, and corticosteroids are commonly used for the initial and maintenance treatments. However, corticosteroid treatment must be discontinued in some patients because of several side effects. This study aimed to evaluate the therapeutic effects of ursodeoxycholic acid (UDCA), which has high tolerability and no severe side effects, on AIH. Our results suggest that to prevent adverse events related to corticosteroids, treatment with UDCA alone for AIH needs to be considered in selected patients, especially those with an alanine aminotransferase level of 200 IU/L or lower. This utility of UDCA must be confirmed in a prospective study.