August 20, 2013
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High-dose infliximab safely, effectively treated JIA patients

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Children with juvenile idiopathic arthritis were safely treated with high doses of infliximab, according to recent study results.

Randy Cron, MD, PhD, of the University of Alabama at Birmingham, department of pediatrics, division of rheumatology, and colleagues conducted a retrospective review of 58 children with juvenile idiopathic arthritis (JIA; median age at diagnosis, 8.9 years; 45% male). All received at least one 10 mg/kg dose of infliximab (IFX) between January 2006, and June 2012. Physician global assessment of disease activity (MD global) and active joint count (AJC) were assessed at initiation of IFX (dosing range, 10 mg/kg to 23.8 mg/kg) and at 3, 6 and 12 months of follow-up.

Forty-eight patients were treated for active arthritis or enthesitis, and 10 were treated for uveitis. During 95 person-years, patients received a combined 1,074 infusions. Eight patients experienced nine serious adverse events (SAE) (9.5/100 person-years), with seven of the SAEs potentially related to therapy. Five patients reported six infusion reactions (0.5%); none constituted anaphylaxis.

Researchers observed significant improvements in MD global and AJC at all time points. From baseline to 12 months, AJC improved from a median of 2 (0-34) to 0 (0-31; P=.001) as did MD global (20, 5-80 vs. 12, 2-31; P=.001).

“To our knowledge, this is the first report of the use of high-dose IFX to treat arthritis in children with JIA, and it is one of the largest reports on the use of IFX doses exceeding 10 mg/kg/dose,” the researchers concluded. “We have not identified any new short-term safety concerns in our cohort, which had a median of 13 months of follow-up, with a maximum of almost 5 years.

“Future work should include a prospective analysis of the safety and effectiveness of standard versus high-dose IFX therapy in children at high risk of complications of JIA.”

Disclosure: Relevant financial disclosures were not provided by researchers.