Meta-analysis: anti-TNF therapy deemed safe for children
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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