Effect of Early Versus Late Azathioprine Therapy in Pediatric Ulcerative Colitis.
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.



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.



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.



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.
*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.
Marina
M
Aloi
Giulia
G
DʼArcangelo
Matteo
M
Bramuzzo
Marco
M
Gasparetto
Massimo
M
Martinelli
Patrizia
P
Alvisi
Maria Teresa
MT
Illiceto
Simona
S
Valenti
Manuela
M
Distante
Salvatore
S
Pellegrino
Simona
S
Gatti
Serena
S
Arrigo
Fortunata
F
Civitelli
Stefano
S
Martelossi
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D001379:Azathioprine / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003082:Colectomy / Q000706:statistics & numerical data; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000601:surgery; D005243:Feces / Q000737:chemistry; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007413:Intestinal Mucosa; D039841:Leukocyte L1 Antigen Complex / Q000032:analysis; D008297:Male; D012042:Registries; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D014945:Wound Healing
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D039841:Leukocyte L1 Antigen Complex; D001379:Azathioprine