Objectives: Although randomized trials demonstrated the efficacy of infliximab for both pediatric Crohn disease and ulcerative colitis (UC), few patients in these studies exhibited colitis requiring hospitalization. The aims of this study were to determine the rate of subsequent infliximab failure and dose escalation in pediatric patients who started taking infliximab during hospitalization for colitis-predominant IBD, and to identify potential predictors of these endpoints.
Methods: This is a single-center retrospective cohort study of patients admitted from 2005 to 2010 with Crohn colitis, UC, or IBD-unspecified (IBD-U) and initiated on infliximab.
Results: We identified 29 patients (12 Crohn colitis, 15 UC, and 2 IBD-U; median age 14 years) with a median follow-up of 923 days. Eighteen patients (62%) required infliximab dose escalation (increased dose or decreased infusion interval). Infliximab failure occurred in 18 patients (62%) because of ineffectiveness in 12 (67%) and adverse reactions in 6 (33%). Twelve patients (41%) underwent colectomy. Subsequent need for infliximab dose escalation was associated with lower body mass index z score (P = 0.01), lower serum albumin (P = 0.03), and higher erythrocyte sedimentation rate (ESR) (P = 0.002) at baseline. ESR predicted subsequent infliximab dose escalation with an area under the curve of 0.89 (95% confidence interval [CI] 0.72–1.00) and a sensitivity and specificity at a cutoff of 38 mm/hour of 0.79 (95% CI 0.49–0.95) and 0.88 (95% CI 0.47–0.99), respectively.
Conclusions: Most hospitalized pediatric patients with colitis treated with infliximab require early-dose escalation and fail the drug long term. Low body mass index and albumin and high ESR, may identify patients who would benefit from a higher infliximab starting dose.
*Department of Pediatrics
†Department of Biostatistics
‡Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN.
Address correspondence and reprint requests to Michael J. Rosen, MD, MSCI, Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 2010, Cincinnati, OH 45229 (e-mail: email@example.com).
Received 22 July, 2013
Accepted 16 August, 2013
This study was supported in part by NIH Training Grant T32DK00767320-S1 (T.O.F.), NIH Award K23DK094832 (M.J.R.), a NASPGHAN George Ferry Young Investigator Award (M.J.R.), Vanderbilt Physician Scientist Development Award (M.J.R.), NIH Award R01 AT004821 (K.T.W.), and NIH CTSA Award UL1TR000445.
The authors report no conflicts of interest.