Effect of Early Versus Late Azathioprine Therapy in Pediatric Ulcerative Colitis

Marina Aloi, Giulia D'Arcangelo, Matteo Bramuzzo, Marco Gasparetto, Massimo Martinelli, Patrizia Alvisi, Maria Teresa Illiceto, S. Valenti, Manuela Distante, Salvatore Pellegrino, Simona Gatti, Serena Arrigo, Fortunata Civitelli, Stefano Martelossi

Research output: Contribution to journalArticlepeer-review


Background: We aimed at describing the efficacy of azathioprine (AZA) in pediatric ulcerative colitis, comparing the outcomes of early (0-6 months) versus late (6-24 months) initiation of therapy. Methods: Children with ulcerative colitis treated with AZA within 24 months of diagnosis were included. Corticosteroid (CS)-free remission and mucosal healing (MH), assessed by endoscopy or fecal calprotectin, at 12 months were the primary outcomes. Patients were also compared for CS-free remission and MH, need for treatment escalation or surgery, number of hospitalizations, and adverse events during a 24-month follow-up. Results: A total of 121 children entered the study (median age 10.5 ± 4.0 years, 59% girls). Seventy-six (63%) started AZA between 0 and 6 months (early group) and 45 (37%) started between 6 and 24 months (late group). Seventy-five percent and 53% of patients in the early and late group, respectively, received CS at the diagnosis (P 0.01). CS-free remission at 1 year was achieved by 30 (50%) of the early and 23 (57%) of the late patients (P 0.54). MH occurred in 37 (37%) patients at 1 year, with no difference between the 2 groups (33% early, 42% late; P 0.56). No difference was found for the other outcomes. Conclusions: Introduction of AZA within 6 months of diagnosis seems not more effective than later treatment to achieve CS-free remission in pediatric ulcerative colitis. MH does not depend on the timing of AZA initiation; however, because of the incomplete comparability of the 2 groups at the diagnosis and the use of fecal calprotectin as a surrogate marker of MH, our results should be further confirmed by prospective studies.

Original languageEnglish
Pages (from-to)1647-1654
Number of pages8
JournalInflammatory Bowel Diseases
Issue number7
Publication statusPublished - Jun 7 2016


  • azathioprine
  • children
  • mucosal healing
  • ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology
  • Immunology and Allergy


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