Background and Objectives: Infliximab is used increasingly as maintenance therapy for inflammatory bowel disease (IBD); however, the effects of a single maintenance dose of infliximab are unclear with respect to the quality of life and hormones related to growth and puberty. The aim of the present study was to determine the time course of inflammatory, hormonal, and quality-of-life changes following a single dose of infliximab in the context of ongoing therapy, as related to presence of IBD symptoms at time of administration.
Methods: Children and adolescents with IBD receiving ongoing therapy with infliximab for clinical indications were recruited. The Pediatric Crohn's Disease Activity Index was determined at baseline and laboratory measures of high-sensitivity C-reactive protein (hsCRP) and hormones of growth and puberty were determined on days 0, 2, and 14. IBD-related quality of life (IMPACT III questionnaire) was tested on days 0 and 14. Subjects who had symptoms of IBD were compared with asymptomatic subjects.
Results: Subjects overall and in the symptomatic group exhibited improved hsCRP by day 2 following treatment. Symptomatic subjects had higher Pediatric Crohn's Disease Activity Index scores and lower quality-of-life scores than asymptomatic subjects on day 0, whereas at day 14 there were no significant differences in quality-of-life scores between the 2 groups.
Conclusions: Even in the context of ongoing treatment, a single dose of infliximab results in decreased hsCRP, an improvement that is particularly noted among subjects who are symptomatic at the time of treatment. Although randomized trials are needed, these observational data may assist clinicians, patients, and families regarding expectations about timing and extent of these changes following a single treatment dose.
*Division of Pediatric Endocrinology
†Division of Pediatric Gastroenterology, University of Virginia, Charlottesville.
Address correspondence and reprint requests to Mark D. DeBoer, MD, MSc, MCR, University of Virginia, Charlottesville, VA 22908 (e-mail: email@example.com).
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Received 15 February, 2011
Accepted 8 September, 2011
The present study received funding from University of Virginia Children's Hospital Grant-in-Aid NIH 5K08HD060739-02, 5M01RR000847-37.
The authors report no conflicts of interest.