Review of Biologics in Children With Rheumatic Diseases

Shabina Habibi; Athimalaipet V Ramanan

Disclosures

Int J Clin Rheumatol. 2012;7(1):81-93. 

In This Article

Infliximab

Infliximab is a chimeric human–mouse monoclonal antibody directed against TNF-α. Unlike etanercept, it triggers apoptosis of cells bearing TNF-α. It is administered as an intravenous infusion, at a dose of 3–6 mg/kg at 0, 2 and 4 weeks and subsequently intervals of 4–8 weeks. Higher doses or shorter dosing intervals may also be used.

A multicenter randomized double-blind placebo-controlled trial of infliximab in 122 children with polyarticular JIA, did not find a significant effect of infliximab 3 mg/kg intravenous infusion therapy on ACR-Pedi responses as compared with placebo at 14 weeks.[23] After 14 weeks, following crossover from placebo to infliximab 6 mg/kg, ACR-Pedi 50 and 70 responses at week 52 were achieved by 70 and 52% of the children. Infliximab 3 mg/kg had a less favorable safety profile, with a higher incidence of infusion reactions, often severe, and formation of antibodies to infliximab, antinuclear antibody or anti-dsDNA antibodies.

In the open-label extension (52–204 weeks) phase of the study involving 78 of 122 patients, 34% discontinued infliximab prematurely, often by withdrawing consent due to lack of efficacy.[24] Infusion reactions were also frequent, occurring in 32% of the children. Overall, 30% of the children continued the study to week 204. The open-label extension phase was thus enriched with responders. Though the trial demonstrated that infliximab was safe, it had a high drop-out rate, mainly due to lack of efficacy.

Infliximab has not been formally approved by the FDA for the treatment of JIA, although it is often used. It is approved for the therapy of refractory Crohn's disease in children over 6 years.

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