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.
"According to previous studies in pediatric UC patients in Western countries, the remission rate after IFX treatment is 38-40%, and the steroid-free rate is 38% at 12 months . In a recent prospective multicenter pediatric study, corticosteroid-free inactive disease in children was observed in 12/44 (27%), 15/39 (38%), and 6/28 (21%) patients at 6, 12, and 24 months after IFX treatment . Our data showed a relatively better response to IFX compared to these studies. "
[Show abstract][Hide abstract] ABSTRACT: Infliximab (IFX) is considered safe and effective for the treatment of ulcerative colitis (UC) in both adults and children. The aim of this study was to evaluate the short- and long-term clinical course of IFX in Korean children with UC.
Pediatric patients with UC who had received IFX infusions between November 2007 and May 2013 at Samsung Medical Center were retrospectively investigated. The clinical efficacy of IFX treatment was evaluated at 8 weeks (short term) and 54 weeks (long term) after the initiation of IFX treatment using the Pediatric Ulcerative Colitis Activity Index (PUCAI). The degree of response to IFX treatment was defined as complete response (PUCAI score=0), partial response (decrement of PUCAI score≥20 points), and non-response (decrement of PUCAI score <20 points). Adverse events associated with IFX treatment were also investigated.
Eleven pediatric patients with moderate to severe UC had received IFX. The remission rate after IFX treatment was 46% (5/11) and 82% (9/11) at 8 weeks and 54 weeks after IFX treatment, respectively. All patients who were steroid-dependent before treatment with IFX achieved remission at 54 weeks and were able to stop treatment with corticosteroids, while all steroid-refractory patients failed to achieve remission at 54 weeks after treatment with IFX.
Response to IFX treatment after 8 weeks may predict a favorable long-term response to IFX treatment in Korean pediatric UC patients.
"On longitudinal follow-up, those who remained with inactive and mild disease decreased to 21 and 11%, respectively, with a cumulative colectomy rate of 16. It is difficult to extrapolate whether this loss of sustained response was secondary to infliximab, as a majority of patients remained on infliximab therapies for varying lengths of time . Longitudinal use of infliximab was more clearly studied in patients with a response to acute infliximab therapy (44 of 60 patients) who were randomized to receive infliximab every 8 or 12 weeks. "
[Show abstract][Hide abstract] ABSTRACT: Ulcerative colitis (UC) is a chronic inflammatory bowel disease that has significant morbidities in the pediatric population. Goals of medical therapy include induction and maintenance of remission while preserving the colon and it’s function, while minimizing the risk of treatment related morbidities. For those children who do not respond to initial therapies and progress to develop moderately-to-severely active UC, there has been a dearth of available treatments to help induce remission, necessitating long-term corticosteroid usage, with associated comorbidities of chronic steroid treatment. Significant advances have been made in medical management, including the use of biologic therapies, specifically anti-tumor necrosis factor-α monoclonal antibodies. With the Food and Drug Administration’s recent approval of the use of infliximab, a chimeric anti-tumor necrosis factor-α antibody, for children ≥6 years of age with moderately-to-severely active UC, care providers now have a new treatment regimen to offer this pediatric population.
"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  . Recently, the effectiveness of IFX in severe ulcerative colitis (UC) has been demonstrated in pediatric patients    . Thus, the use of IFX in pediatric inflammatory bowel disease (IBD) is likely to increase further in the future. "
[Show abstract][Hide 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.
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.
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.
Christine Norton, Lesley B Dibley, Ailsa Hart, Julie Duncan, Anton Emmanuel, Charles H Knowles, Natasha Stevens, Helen Terry, Azmina Verjee, Sally Kerry, Natalia Hounsome
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