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Risk for lymphoma, serious infection did not increase with anti-TNF therapy for pediatric IBD
Risk for lymphoma was not increased in children receiving anti-tumor necrosis factor therapy for inflammatory bowel disease compared with adults receiving the same therapy, or pediatric patients receiving other therapies. Furthermore, risk for serious infection was significantly lower compared with the aforementioned groups, according to research data.
To calculate incidence of lymphoma, serious infection and death associated with anti-tumor necrosis factor (TNF) therapy for pediatric inflammatory bowel disease (IBD), investigators performed a systematic literature review for studies on anti-TNF treatment for pediatric Crohn’s disease (CD) and ulcerative colitis (UC). Infection and cancer rates in children who received anti-TNF therapy for IBD were compared with expected rates from children who received alternative therapies for IBD and adult patients who received anti-TNF therapy for IBD.
Sixty-five included studies reported on 5,528 patients with 9,516 patient-years of follow-up (PYF). Pediatric IBD patients exposed to anti-TNF agents had a similar rate of serious infections (352/10,000 PYF) compared with those treated with immunomodulator monotherapy (333/10,000 PYF; SIR=1.06; 95% CI, 0.83-1.36), but lower rates compared with children who received steroids for IBD (730/10,000 PYF; SIR=0.48; 95% CI, 0.4-0.58) and adults who received anti-TNF therapy for IBD (654/10,000 PYF; SIR=0.54; 95% CI, 0.43-0.67).
Lymphoma rate in children treated with anti-TNF agents for IBD (2.1/10,000 PYF) was similar compared with the expected rate in the general pediatric population (5.8/100,000 PYF; SIR=3.5; 95% CI, 0.35-19.6), and numerically but not statistically lower compared with children receiving thiopurine monotherapy for IBD (4.5/10,000 PYF; SIR=0.47; 95% CI, 0.03-6.44) and adults treated with anti-TNF agents (6.1/10,000 PYF; SIR=0.34; 95% CI, 0.04-1.51). Absolute rate of death associated with anti-TNF therapy for pediatric IBD was 5.3 per 10,000 PYF.
“Anti-TNF therapy in pediatric IBD appears to be safe and well tolerated,” the investigators concluded. “Overall, the risk of serious infection, lymphoma, and death with anti-TNF therapy in pediatric IBD is very low.”
Disclosure: See the study for a full list of relevant financial disclosures.