Predictors of Immunomodulator Use as Early Therapy in Pediatric Crohn's Disease

Goals: The goals of this study were to identify markers in a patient's presentation and disease progression that predict the need for the use of immunomodulators in a pediatric population. Background: Although immunomodulator safety and efficacy have been documented in Crohn's disease, models for predicting outcome and the need for immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate) early in the disease course have not been investigated in children or adults. Methods: Data on newly diagnosed Crohn's disease patients were prospectively collected within 3 weeks of diagnosis, 6 months after diagnosis, and 1 year after diagnosis. Information collected at each visit included medication use and disease activity assessment. Results: A total of 57 patients who were followed for ≥6 months were evaluated. Overall, 34 of 57 (59.6%) were started on immunomodulators within 1 year of diagnosis. Mean serum albumin (3.35 g/dL vs. 3.7 g/dL, P = 0.013) and hematocrit (33.3% vs. 35.9%, P = 0.023) at diagnosis were lower, and erythrocyte sedimentation rate (32 vs. 12, P = 0.011) at diagnosis was higher in patients who required immunomodulators. The total Pediatric Crohn's Disease Activity Index score as well as the physical examination score and patient recall score within the PCDAI at diagnosis were not different among those who received immunomodulators and those that did not. Conclusions: Immunomodulators are frequently used within 1 year of diagnosis in pediatric Crohn's disease. Lower serum albumin levels and hematocrit, and elevated erythrocyte sedimentation rate at diagnosis may predict the need for immunomodulators earlier in the disease course.