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Effect of Early Versus Late Azathioprine Therapy in Pediatric Ulcerative Colitis
Marina Aloi1, Giulia DʼArcangelo, Matteo Bramuzzo
1*Pediatric Gastroenterology and Liver Unit, Department of Pediatrics, Sapienza University of Rome, Roma, Italy; †Institute for Maternal and Child Health IRCCS "Burlo Garofolo," Trieste, Italy; ‡Department of Pediatric Gastroenterology, University of Padua, Padua, Italy; §Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II," Naples, Italy; ‖Pediatric Department, Maggiore Hospital, Bologna, Italy; ¶Pediatric Gastroenterology and Endoscopy Unit, Spirito Santo Hospital, Pescara, Italy; Departments of **Pediatric Gastroenterology and Endoscopy, and ††Pediatric Gastroenterology, University of Messina, Messina, Italy; ‡‡Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy; and §§Pediatric Department, Gastroenterology and Nutrition Unit, Institute "Giannina Gaslini," Genoa, Italy.
Insights
Early azathioprine (AZA) initiation (0-6 months) in pediatric ulcerative colitis showed no significant benefit over later treatment (6-24 months) for achieving corticosteroid-free remission or mucosal healing. Timing of AZA therapy does not appear to impact key outcomes in children with ulcerative colitis.
Area of Science:
- Pediatric Gastroenterology
- Immunosuppressive Therapy
- Inflammatory Bowel Disease
Background:
- Pediatric ulcerative colitis (UC) management often involves immunosuppressants like azathioprine (AZA).
- The optimal timing for initiating AZA therapy in pediatric UC remains unclear.
- This study compares early versus late AZA initiation in children with UC.
Purpose of the Study:
- To evaluate the efficacy of early (0-6 months) versus late (6-24 months) azathioprine (AZA) initiation in pediatric ulcerative colitis.
- To compare outcomes including corticosteroid-free remission and mucosal healing at 12 months.
- To assess treatment escalation, surgery, hospitalizations, and adverse events over 24 months.
Main Methods:
- Retrospective analysis of 121 pediatric UC patients treated with AZA within 24 months of diagnosis.
- Primary outcomes: corticosteroid (CS)-free remission and mucosal healing (MH) at 12 months.
- Secondary outcomes: treatment escalation, surgery, hospitalizations, and adverse events over 24 months.
Main Results:
- No significant difference in CS-free remission at 1 year between early (50%) and late (57%) AZA groups (P=0.54).
- Mucosal healing rates at 1 year were similar: 33% in the early group and 42% in the late group (P=0.56).
- No differences observed in other assessed outcomes between the early and late AZA initiation groups.
Conclusions:
- Initiating azathioprine (AZA) within 6 months of diagnosis does not appear more effective than later treatment for achieving corticosteroid-free remission in pediatric ulcerative colitis.
- Mucosal healing in pediatric UC is not dependent on the timing of AZA initiation.
- Further prospective studies are needed to confirm these findings due to group incomparability at diagnosis and use of surrogate markers for MH.
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.
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