Article

Outcome Following Infliximab Therapy in Children With Ulcerative Colitis

Connecticut Children's Medical Center, Hartford, Connecticut 06106, USA.
The American Journal of Gastroenterology (Impact Factor: 9.21). 06/2010; 105(6):1430-6. DOI: 10.1038/ajg.2009.759
Source: PubMed

ABSTRACT Infliximab is effective in treating moderate/severe ulcerative colitis (UC) in adults. The aim of this study was to determine the outcome after treatment with infliximab in pediatric UC.
We performed a multicenter cohort study of 332 pediatric patients with UC enrolled in the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry. Children<or=16 years of age and newly diagnosed with UC are enrolled in the registry. Disease and medication information are collected prospectively from the treating physician at diagnosis, 30 days, and quarterly thereafter. No interventions were specified, per protocol.
Of 332 patients, 52 (16%) received infliximab (23%<3 months from diagnosis, 38% 3-12 months, 38% >12 months). Mean age at infliximab initiation was 13.3+/-2.6 (range 6-17) years; 87% of patients had pancolitis. Median follow-up was 30 months. Continuous maintenance (CM) therapy was given in 65%, episodic in 21%, episodic converted to CM in 6%, and insufficient data in 8% of patients. Sixty-three percent of patients were corticosteroid refractory, and 35% were corticosteroid dependent. Concomitant medications at first infliximab infusion included corticosteroids (87%), thiopurines (63%), and 5-aminosalicylates (51%). Corticosteroid-free inactive disease by physician global assessment was noted in 12/44 (27%), 15/39 (38%), and 6/28 (21%) patients at 6, 12, and 24 months, respectively. Kaplan-Meier analysis showed that the likelihood of remaining colectomy free after treatment with infliximab was 75% at 6 months, 72% at 12 months, and 61% at 2 years.
In this cohort of children with UC receiving infliximab, corticosteroid-free inactive disease was observed in 38 and 21% of patients at 12 and 24 months, respectively. By 24 months, 61% of patients had avoided colectomy.

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    • "As in adults, infliximab (IFX), chimeric monoclonal antibody (IgG1) against TNF-is effective in children with moderate to severe Crohn's disease in inducing and maintaining remission [1] [2]. Recently, the effectiveness of IFX in severe ulcerative colitis (UC) has been demonstrated in pediatric patients [3] [4] [5] [6]. Thus, the use of IFX in pediatric inflammatory bowel disease (IBD) is likely to increase further in the future. "
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    ABSTRACT: Abstract Objective. To study serum infliximab (s-IFX) levels in pediatric patients with inflammatory bowel disease (IBD). Subjects and methods. s-IFX trough levels were measured in a total of 133 blood samples of 37 pediatric IBD patients (Crohn's disease, 23): 48 during the induction phase (weeks 2 and 6) and 85 during maintenance treatment. Antibodies to infliximab (ATI) were determined in 93 samples (30 patients). s-IFX values were related to fecal calprotectin (FC) and serum markers of inflammation. Results. During induction (5 mg/kg) and maintenance therapy, the median s-IFX levels were 17.6 μg/ml (range 0-48 μg/ml) and 3.55 μg/ml (range 0-40 μg/ml), respectively. The IFX levels were similar in ulcerative colitis and Crohn's disease (e.g. during maintenance median 3.2 vs. 2.8 μg/ml, p = 0.718), thus the data are pooled. During induction, the s-IFX level was associated with the total dose of IFX, that is, young children with lower body weight had lower levels (p < 0.001 at week 2 and p < 0.05 at week 6). Shorter administration interval resulted in higher trough levels (p < 0.005). All samples with undetectable s-IFX (6.8%) levels presented ATI. High inflammation (FC >1000 µg/g) during induction was associated with lower s-IFX levels (median 4.0 μg/ml, range 0.47-25 compared to median 20 μg/ml, range 0-48 when FC <1000 µg/g, p < 0.005). There was no significant association between the ESR or values of C-reactive protein and s-IFX levels during induction. Conclusions. In pediatric IBD, lower body weight and higher level of intestinal inflammation are associated to s-IFX levels during induction but relation to therapeutic response is unclear.
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    • "The anti-Tumour necrosis factor-(TNF) alpha inhibitor Infliximab has been evaluated in adult and paediatric UC. A recent report demonstrated the benefits of infliximab in paediatric UC (Hyams et al 2010). "
    Ulcerative Colitis - Treatments, Special Populations and the Future, 11/2011; , ISBN: 978-953-307-739-0
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