Azathioprine for prevention of clinical recurrence in Crohn’s disease patients with severe endoscopic recurrence: An IG-IBD randomized double-blind trial

A. Orlando, F. Mocciaro, M. Ventimiglia, S. Renna, A. Rispo, M. L. Scribano, A. Testa, A. Aratari, F. Bossa, E. Angelucci, S. Onali, M. Cappello, M. Giunta, D. Scimeca, F. S. Macaluso, F. Castiglione, C. Papi, V. Annese, L. Biancone, A. KohnR. D.I. Mitri, M. Cottone

Research output: Contribution to journalArticlepeer-review


OBJECTIVE: The recurrence of Crohn’s Disease after ileo-colonic resection is a crucial issue. Severe endoscopic lesions increase the risk of developing early symptoms. Prevention and treatment of post-operative Endoscopic Recurrence (ER) have been studied with conflicting results. We compare efficacy of azathioprine (AZA) vs. high-dose 5-aminosa-licylic acid (5-ASA) in preventing clinical recurrence and treating severe post-operative ER. PATIENTS AND METHODS: We performed a 1-year multicenter randomized double-blind double-dummy trial. Primary end-points were endoscopic improvement and therapeutic failure (clinical recurrence or drug discontinuation due to lack of efficacy or adverse events) 12 months after randomization. We also performed a post-trial analysis on symptomatic and endoscopic outcomes 10 years after the beginning of the trial, with a median follow-up of 60 months. RESULTS: Therapeutic failure occurred in 8 patients (17.4%) within 12 months from randomization, with no significant difference between patients treated with 5-ASA (20.8%, 5 patients) and those with AZA (13.6%, 3 patients). Therapeutic failure was due to clinical recurrence in the 5-ASA group and to adverse events in the AZA group. Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group. No serious adverse event was recorded. At the post-trial analysis (median follow-up 60 months), 47.8% (22/46) of patients experienced clinical recurrence: 54.2% (13/24) in the 5-ASA group and 40.9% (9/22) in the AZA group, p=0.546. Patients treated with AZA had lower risk of drug escalation. Clinical recurrence was associated with smoking (p=0.031) and previous surgery (p=0.003). CONCLUSIONS: Our trial indicates that there was no difference in terms of treatment failure between 5-ASA and AZA in patients with severe post-operative ER. The main limit of AZA is its less favorable safety profile.

Original languageEnglish
Pages (from-to)11356-11364
Number of pages9
JournalEuropean Review for Medical and Pharmacological Sciences
Issue number21
Publication statusPublished - 2020


  • Azathioprine
  • Clinical Trial
  • Crohn’s Disease
  • Italian Group (IG)
  • Mesalamine
  • Post-Surgical Endoscopic Recurrence
  • Prevention

ASJC Scopus subject areas

  • Pharmacology (medical)


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