Crepaldi M, Maniero D, Massano A, Pavanato M, Barberio B, Savarino EV, Zingone F. Azathioprine monotherapy withdrawal in inflammatory bowel diseases: A retrospective mono-centric study. World J Gastroenterol 2023; 29(27): 4334-4343 [PMID: 37545640 DOI: 10.3748/wjg.v29.i27.4334]
Corresponding Author of This Article
Fabiana Zingone, MD, PhD, Assistant Professor, Doctor, Department of Surgery, Oncology, and Gastroenterology, University of Padua, Via Giustiniani 2, Padua 35128, Italy. fabiana.zingone@unipd.it
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Observational 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/
Martina Crepaldi, Daria Maniero, Alessandro Massano, Margherita Pavanato, Brigida Barberio, Edoardo Vincenzo Savarino, Fabiana Zingone, Department of Surgery, Oncology, and Gastroenterology, University of Padua, Padua 35128, Italy
Author contributions: Zingone F conceived and designed the study and analyzed the findings; Crepaldi M and Maniero D collected data and wrote the manuscript; Massano A, Pavanato M, Barberio B, and Savarino EV collected data; All authors revised and approved the final version.
Institutional review board statement: The Ethical Committees of the Padova University Hospital reviewed and approved this study.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Data, analytical methods, and study materials are available to other researchers upon specific request.
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.
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: Fabiana Zingone, MD, PhD, Assistant Professor, Doctor, Department of Surgery, Oncology, and Gastroenterology, University of Padua, Via Giustiniani 2, Padua 35128, Italy. fabiana.zingone@unipd.it
Received: March 27, 2023 Peer-review started: March 27, 2023 First decision: May 18, 2023 Revised: June 4, 2023 Accepted: July 3, 2023 Article in press: July 3, 2023 Published online: July 21, 2023 Processing time: 107 Days and 17.8 Hours
ARTICLE HIGHLIGHTS
Research background
Before the advent of biological drugs, azathioprine (AZA) was used worldwide to treat inflammatory bowel disease (IBD) patients and is still used. It is recognized that this immunomodulating agent could induce and sustain steroid-free long-term remission. However, clinicians cannot ignore the possible adverse effects of long-term AZA treatment and the risk of relapses after its discontinuation. In this retrospective study, we want to share the experience of our tertiary center with IBD patients treated with AZA.
Research motivation
Determining the optimal duration and cessation time helps balance the risks of long-term intake with the possibility of relapse after cessation.
Research objectives
In this study, we analyzed IBD patients who started and discontinued AZA. We have focused on patients' demographic and clinical characteristics, reasons for cessation, side effects, and disease incidence rate after AZA withdrawal.
Research methods
We conducted a retrospective study, including IBD patients older than 18 who had started AZA between 1995 and 2022 and then discontinued for any reason and were followed at our IBD clinic. For categorical variables, we have used the χ2 test and Student's t-test for continuous variables. We have estimated disease relapse hazard ratios using the Cox regression model.
Research results
AZA discontinuation was due to primary failure or disease relapse in 30% of patients and due to disease remission in 25.2% of patients. We found that patients who discontinued AZA after a sustained remission of an average time of 5 years and 4 mo had a low risk of relapse (10%) in 1 year.
Research conclusions
This study addresses an unanswered question: “When is it possible to discontinue AZA? How long should we wait before AZA cessation?”. Our study proves that AZA could be safely discontinued after 5 years of sustained remission because we have observed a lower relapse rate at 1-year follow-up. The main limitation of the study was the small size of patients.
Research perspectives
For advanced evidence, future prospective research should be conducted to evaluate the long-term natural history of IBD after withdrawal of AZA.
