Published online Jul 21, 2023. doi: 10.3748/wjg.v29.i27.4334
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
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.
Determining the optimal duration and cessation time helps balance the risks of long-term intake with the possibility of relapse after cessation.
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.
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.
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.
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.
For advanced evidence, future prospective research should be conducted to evaluate the long-term natural history of IBD after withdrawal of AZA.