Retrospective Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 21, 2019; 25(7): 859-869
Published online Feb 21, 2019. doi: 10.3748/wjg.v25.i7.859
Δ4-3-oxosteroid-5β-reductase deficiency: Responses to oral bile acid therapy and long-term outcomes
Mei-Hong Zhang, Kenneth DR Setchell, Jing Zhao, Jing-Yu Gong, Yi Lu, Jian-She Wang
Mei-Hong Zhang, Jing-Yu Gong, Department of Pediatrics, Jinshan Hospital, Fudan University, Shanghai 201508, China
Kenneth DR Setchell, Department of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, United States
Jing Zhao, Yi Lu, Jian-She Wang, The Center for Pediatric Liver Diseases, Children’s Hospital of Fudan University, Shanghai 201102, China
Jing Zhao, Yi Lu, Jian-She Wang, Department of Pediatrics, Shanghai Medical College of Fudan University, Shanghai 201102, China
Author contributions: Zhang MH, Setchell KD, and Zhao J contributed equally to preparation and revision of the manuscript; Gong JY and Lu Y contributed to collection of the clinical data; Setchell KD performed mass spectrometry analysis of patient samples; Wang JS contributed to the paper design, drafting, and revision; all authors contributed to the patient management and approved the final manuscript.
Supported by the National Natural Science Foundation of China, No. 81570468 and No. 81741056; and Jinshan Science and Technology Commission, No. 2014-3-07.
Institutional review board statement: This study was approved by the institutional review board of Children’s Hospital of Fudan University.
Informed consent statement: Informed consent was obtained from each patient.
Conflict-of-interest statement: Setchell KD is a consultant to Retrophin San Diego, United States, and holds a minor equity in Asklepion Pharmaceuticals. The other authors declare no conflicts of interest.
Data sharing statement: No additional data are available.
Open-Access: This 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 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/
Corresponding author: Jian-She Wang, MD, PhD, Professor, The Center for Pediatric Liver Diseases, Children’s Hospital of Fudan University, 399 Wanyuan Road, Shanghai 201102, China. jshwang@shmu.edu.cn
Telephone: +86-21-64931171 Fax: +86-21-64931901
Received: October 22, 2018
Peer-review started: October 22, 2018
First decision: December 12, 2018
Revised: January 11, 2019
Accepted: January 18, 2019
Article in press: January 18, 2019
Published online: February 21, 2019
Processing time: 123 Days and 19.8 Hours
ARTICLE HIGHLIGHTS
Research background

The Δ4-3-oxosteroid 5β-reductase (AKR1D1) deficiency is a rare bile acid synthesis disorder. There have been few reports describing the effectiveness of treatment regimens for this rare genetic disease and the long-term outcomes of oral primary bile acid therapy are unclear. This study provides evidence on how these patients should ideally be managed.

Research motivation

Oral cholic acid (CA), one of the two primary bile acids synthesized by the liver, is an approved therapy for the treatment of bile acid synthesis disorders but is not available to many patients. Chenodeoxycholic acid (CDCA), the other primary bile acid, offers an alternative potential therapy but has been contraindicated in a few reported cases of AKR1D1 deficiency due to its more hydrophobic and potentially hepatotoxic effects. However, in the absence of access to CA in China, we evaluated the effectiveness of CDCA in patients with AKR1D1 deficiency and showed that provided that the therapeutic doses is individually optimized, it is an effective treatment for this disorder.

Research objectives

Through retrospective analysis of the clinical and biochemical responses to bile acid therapy with CDCA in patients with AKR1D1 deficiency, our objective was to better understand the disease progression and long-term outcomes of treatment in order to make recommendations regarding its effectiveness and safety.

Research methods

Twelve patients with confirmed AKR1D1 deficiency, diagnosed by fast atom bombardment ionization-mass spectrometry analysis of the urinary bile acid profile and by gene sequencing of AKR1D1, were treated with oral bile acids. The clinical and biochemical responses to CDCA therapy were retrospectively evaluated and analyzed, including the results on urinary bile acid profiles and serum liver function indices.

Research results

Physical examination, biochemistry parameters, and sonographic findings improved in the patients during CDCA therapy, except for one who underwent liver transplantation. The urinary levels of atypical hepatotoxic 3-oxo-Δ4 bile acids were suppressed concomitantly with clinical improvements in those patients treated with CDCA, but not with ursodeoxycholic acid (UDCA). The dose of CDCA varied from 5.5-10 mg/kg per day among patients based on maximum suppression of the atypical bile acids.

Research conclusions

CDCA is an effective alternative therapy to CA, provided that the dose is carefully optimized on an individual patient basis to minimize side effects. UDCA does not achieve the therapeutic goal of suppressing the production of atypical hepatotoxic bile acids and is not recommended for long-term treatment.

Research perspectives

CDCA is effective in the treatment of the patients with AKR1D1 deficiency. However, CDCA is intrinsically hepatotoxic, and therefore its dose must be optimized to individual patients. Future studies should focus on continued long-term monitoring of these patients to provide more detailed information of the natural history of this rare metabolic liver disease and to determine long-term outcomes of therapy with primary bile acids.