Assessing the associations between immunosuppressant use and COVID-19 severity in patients with autoimmune hepatitis
Krish Rai, Karla J Lindquist, John Kornak, Department of Epidemiology and Biostatistics, University of California, San Francisco, CA 94143, United States
Jin Ge, Department of Medicine, University of California, San Francisco, CA 94143, United States
Author contributions: Rai K contributed to manuscript drafting; Rai K and Ge J contributed to data extraction and statistical analysis; Rai K, Lindquist KJ, Kornak J, and Ge J contributed to critical revision of the manuscript for important intellectual content, analysis and interpretation of data; Ge J contributed to study concept and design, study supervision.
Supported by National Institute of Diabetes and Digestive and Kidney Diseases, No. K23DK139455; and UCSF Liver Center Grant, No. 5P30DK026743-43.
Institutional review board statement: Submissions of data from individual centers to N3C are governed by a central institutional review board (IRB) protocol #IRB00249128 hosted at Johns Hopkins University School of Medicine via the SMART IRB40 master common reciprocal reliance agreement. This central IRB covers data contributions and transfers to N3C but does not cover research using N3C data. If elected, individual sites may choose to exercise their own local IRB agreements instead of utilizing the central IRB. As the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) is the steward of the repository, data received and hosted by NCATS on the N3C COVID data enclave, its maintenance, and its storage are covered under a central NIH IRB protocol to make EHR-derived data available for the clinical and research community to use for studying COVID-19. Our institution has an active data transfer agreement with N3C. This specific analysis of the N3C COVID data enclave was approved by N3C under data use agreements titled “[RP-E77B79] COVID-19 outcomes in vaccinated patients with liver diseases. The use of N3C data for this study was authorized by the IRB at the University of California, San Francisco under study, No. 21-35861.
Informed consent statement: Informed consent was waived for this study as this was a retrospective analysis of a de-identified electronic health record database.
Conflict-of-interest statement: Ge J reports grants from Merck and Co, other from Gilead Sciences, other from Madrigal Pharmaceuticals, other from Astellas Pharmaceuticals/Iota Biosciences, outside the submitted work.
STROBE statement: The authors have read the STROBE Statement – checklist of items, and the manuscript was prepared and revised according to the STROBE Statement – checklist of items.
Data sharing statement: Data utilized for this analysis is available from the National Clinical Cohort Collaborative (N3C) COVID enclave.
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:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Jin Ge, MD, Assistant Professor, Department of Medicine, University of California, 513 Parnassus Avenue, S-357, San Francisco, CA 94143, United States.
jin.ge@ucsf.edu
Received: September 22, 2025
Revised: October 13, 2025
Accepted: December 16, 2025
Published online: February 27, 2026
Processing time: 145 Days and 8.5 Hours