Meta-analysis: anti-TNF therapy deemed safe for children
(HealthDay)—For children with inflammatory bowel disease (IBD), treatment with anti-tumor necrosis factor (TNF) therapy appears to be safe, according to research published in the September issue of Clinical Gastroenterology and Hepatology.
Parambir S. Dulai, M.D., from the Dartmouth Hitchcock Medical Center in Lebanon, N.H., and colleagues conducted a systematic review and meta-analysis to quantify the incidence of serious infection, lymphoma, and death in pediatric patients with IBD who received anti-TNF therapy. Standardized incidence ratios (SIRs) were calculated for pediatric patients exposed to anti-TNF agents (5,528 patients with 9,516 patient-years of follow-up [PYF]) compared with expected rates from pediatric patients not exposed to anti-TNF therapies or adult patients exposed to anti-TNF agents.
The researchers found that the rate of serious infections was 352/10,000 PYF, which was similar to that of pediatric patients who received immunomodulation monotherapy (333/10,000 PYF; SIR, 1.06; 95 percent confidence interval [CI], 0.83 to 1.36). The rate was significantly lower than the expected rate for pediatric steroid-treated patients (730/10,000 PYF; SIR, 0.48; 95 percent CI, 0.40 to 0.58) and for anti-TNF-treated adults (654/10,000 PYF; SIR, 0.54; 95 percent CI, 0.43 to 0.67). There were five treatment-related deaths and two cases of lymphoma, which was similar to the expected lymphoma rate for the entire pediatric population (2.1/10,000 PYF versus 5.8/10,000 PYF; SIR, 3.5; 95 percent CI, 0.35 to 19.6).
"Our pooled analysis showed that anti-TNF therapy in pediatric IBD appears to be safe and well tolerated," the authors write.
Two authors disclosed financial ties to the pharmaceutical industry.
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