Abstract

Abstract Background Crohn's disease (CD) is a chronic and disabling immune-mediated disease of the digestive tract, and immunosuppressive drugs are a cornerstone in the therapeutic approach, particularly purine analogues which are widely used in the treatment of CD as an agent to maintain remission. Despite their widespread use, adverse effects are frequent and lead to discontinuation of treatment in a significant proportion of patients so the increasing use of anti-TNFα biologics may have had an impact on the use of thiopurines. We present a long-term retrospective experience from a tertiary hospital center aimed at studying the evolution of thiopurine monotherapy use in the era of biologics, based on current therapeutic goals and safety standards. Methods We performed a retrospective analysis of all Crohn's disease patients followed up in our hepato-gastroenterology department who received AZA monotherapy at the standard dose (2-2.5 mg/kg/d) or 6-MP (1-1.5 mg/kg/d) at any time during their follow-up between January 2016 and June 2023 and who were still being followed up at that time. Patients who had received prior or concomitant biological treatment were excluded from the analysis. Various socio-demographic and phenotypic data were collected. Failure was defined as discontinuation of treatment due to lack of efficacy or AE. Statistical analysis was performed using SPSS2.0 software. Statistical significance was set at p < 0.05. Results A total of 383 patients were included: 46.5% were men and the mean age was 31 years (range 17-65). Median follow-up was 66 months. Indications for thiopurine monotherapy were cortico-dependence (306 patients, 80%) or prevention of postoperative recurrence (77 patients, 20%). Overall, 147 patients (38%) failed. The observational study of our patients showed that 74 patients (18.4%) discontinued AZA due to an adverse event (most of which occurred during the first month of treatment), 73 (19%) due to lack of efficacy. Among the main indications for AZA we note: prevention of postoperative recurrence, male gender gave better results than steroid dependence (p =0.001); perianal fistulization of CD and grecal localization gave worse results (p = 0.002). Conclusion In our experience, a significant proportion of CD patients on thiopurine monotherapy failed. Although IS monotherapy remains useful for CD in the era of biologics, current clinical practice is moving towards anti-TNFα biologics in an increasing proportion of patients.

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