Utilization and Clinical Outcome Following 5-Aminosalicylate Therapy for Crohn's Disease in Children

Abstract

Objectives: Despite little data on efficacy, 5-Aminosalicylates (5ASA) are commonly used in pediatric Crohn’s Disease (CD). Our aim was to assess prevalence of 5-ASA utilization in children newly diagnosed with CD, as well as clinical outcomes among these patients. Study design: Data were obtained from a large observational inception cohort from 2002-2014. First, we analyzed initial treatments received immediately following diagnosis. Then, clinical outcome and disease activity were measured using the “Physician Global Assessment” (PGA) scale. The primary outcome was a PGA of “inactive”, without corticosteroids (CS), immunomodulators, biologics or surgery one year following diagnosis in patients receiving 5-ASA ± CS only as initial therapy following diagnosis. Results: 440/1297 subjects with CD (34%) received 5-ASA ± CS only as initial therapy, and were the focus of this study. No baseline differences were observed between the 5-ASA + CS (n=263) vs. 5-ASA CS (n=177) treatment groups for age, gender, disease distribution or disease behavior. Baseline moderate/severe PGA was more common in the 5-ASA + CS group compared with the 5-ASA alone group (70% vs. 38%, p<0.001). The primary outcome was achieved by 34% of those treated with 5-ASA alone vs. 18% of those treated with 5-ASA + CS (p<0.001). In multivariate models, achieving the primary outcome was significantly associated with initially mild disease severity and no initial CS use. Conclusion: The prevalence of 5-ASA utilization for pediatric CD is high despite a low likelihood of achieving clinical remission on 5-ASA therapy, although somewhat more favorable for select children with mild disease who do not receive CS at diagnosis.