Objectives
While randomized trials demonstrated efficacy of infliximab for both pediatric Crohn’s disease (CD) 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 started on infliximab during hospitalization for colitis-predominant IBD, and to identify potential predictors of these endpoints.
Methods
Single center retrospective cohort study of patients admitted from 2005 to 2010 with Crohn’s colitis, UC, or IBD-unspecified (IBD-U) and initiated on infliximab.
Results
We identified 29 patients (12 Crohn’s colitis, 15 UC, and 2 IBD-U; median age 14 years) with a median follow-up of 923 days. 18 patients (62%) required infliximab dose escalation (increased dose or decreased infusion interval). Infliximab failure occurred in 18 patients (62%), due to ineffectiveness in 12 (67%) and adverse reactions in 6 (33%). 12 patients (41%) underwent colectomy. Subsequent need for infliximab dose escalation was associated with lower body mass index (BMI) z-score (P=0.01), lower serum albumin (P=0.03), and higher ESR (P=0.002) at baseline. ESR predicted subsequent infliximab dose escalation with an area under the curve of 0.89 (95% CI 0.72–1.00) and a sensitivity and specificity at a cutoff of 38 mm/hr 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 BMI and albumin, and high ESR may identify patients who would benefit from a higher infliximab starting dose.
longer in ATI positive patients comparing with negative patients (26.8 6 23.9 months versus 16.9 6 19.2 months; respectively). None of other lab results and demographic parameters (age, gender, BMI) was associated with positive ATI. We investigated potential factors that may affect infliximab levels including age, gender, BMI, CRP, fecal calprotectin, duration of treatment, premedication and ATI presence. A statistically significant correlation was only found for detectable infliximab levels with higher BMI and with negative ATI (P < 0.05). Interestingly, detectable infliximab levels were noted more in premedication group compared to no premedication (98% versus 89%), however the association did not reach statistical significance (P ¼ 0.06). No significant associations were found in all other variables. Conclusions: Our data suggests that premedication does not appear to decrease the prevalence of ATI formation. As has been suggested by prior studies, our study confirmed that use of dual therapy with addition of immunomodulator does lead to less ATI formation. Interestingly, premedication was more likely to be associated with a detectable infliximab level.
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