Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 21, 2023; 29(27): 4334-4343
Published online Jul 21, 2023. doi: 10.3748/wjg.v29.i27.4334
Azathioprine monotherapy withdrawal in inflammatory bowel diseases: A retrospective mono-centric study
Martina Crepaldi, Daria Maniero, Alessandro Massano, Margherita Pavanato, Brigida Barberio, Edoardo Vincenzo Savarino, Fabiana Zingone
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
Abstract
BACKGROUND

There is no consensus on the recommended duration of and optimal time to stop azathioprine (AZA) therapy in inflammatory bowel disease (IBD). Determining the optimal duration and cessation time can help to balance the risks of long-term intake with the possibility of relapse after cessation.

AIM

To describe the events following AZA cessation.

METHODS

Retrospective analysis was performed to examine data from adult patients affected by IBD who were followed at the University of Padua and had started but then discontinued AZA between 1995 and 2022. Data on therapy duration, reasons for cessation, and type of relapse after cessation were collected. Cox regression models were used to estimate the risk of relapse in different subgroups.

RESULTS

A total of 133 ulcerative colitis patients and 141 Crohn’s disease patients were included. Therapy with AZA was stopped in the 1st year in approximately 34% of patients but was continued for more than 10 years in approximately 10% of cases. AZA discontinuation was due to primary failure or disease relapse in 30% of patients and due to disease remission in 25.2% of patients. Most of the remaining cases stopped AZA therapy due to side effects (primarily clinical intolerance, cytopenia, and pancreatic disease). Patients who stopped AZA for clinical remission had an 83% lower risk of relapse during the observation time than other groups, with a relapse-free rate of 89% after 1 year and 79% after 2 years.

CONCLUSION

AZA administration is effective and safe, but it requires careful monitoring for potential minor and major side effects. Only 10% of patients who achieved remission with AZA needed a new treatment within 1 year of drug interruption.

Keywords: Azathioprine, Inflammatory bowel diseases, Ulcerative Colitis, Crohn's Disease, Relapse, Side effects

Core Tip: Prolonged use of azathioprine (AZA) remains controversial, and the time of interruption is uncertain. This retrospective study analyzed our single-center data of patients affected by inflammatory bowel disease who had started and then discontinued AZA between 1995 and 2022. AZA administration was effective and safe, and only 10% of patients who achieved remission with AZA needed a new treatment within 1 year of drug interruption.