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

Adalimumab

Adalimumab is a fully humanized monoclonal IgG1 antibody against TNF-α. It was the second anti-TNF agent to receive FDA approval for the treatment of moderate-to-severe active polyarticular JIA in children over 4 years of age. It is administered subcutaneously at a dose of 20 mg every other week in children weighing less than 30 kg, and 40 mg every other week in children weighing more than 30 kg.

In a multicenter study of 171 children with polyarticular course of JIA, with a similar trial design as the initial etanercept trial, comprising an open-label lead-in phase, followed by a double-blind, placebo-controlled phase, and an open-label extension phase, children were treated with 24 mg/m2 of adalimumab.[17] Eighty-four children were receiving concomitant methotrexate. A total of 74, 64, 46 and 26% of children receiving adalimumab monotherapy, and 94, 91, 71 and 28% children receiving a combination of methotrexate and adalimumab achieved ACR-Pedi 30, 50, 70 and 90 responses, respectively. In the placebo-controlled phase, significantly more children receiving placebo flared (71 and 65% on placebo and placebo plus methotrexate, vs 43 and 37% on adalimumab and adalimumab plus methotrexate combination). The drug was found to be reasonably safe, with only minimal adverse effects. In the 2 years of the open-label extension phase, ACR-Pedi responses were sustained, and 40% of children had ACR-Pedi 100 responses. This study demonstrated the safety and efficacy of adalimumab, with and without combined methotrexate, in the treatment of polyarticular course of JIA.

Biologics including infliximab and adalimumab have been used in clinical practice in children with refractory JIA-associated uveitis. No good quality evidence in the form of controlled trials is currently available in the literature. Small case series and retrospective studies have also suggested the effectiveness of adalimumab in the treatment of JIA-associated uveitis, which can occur in about 10–15% of children with JIA.[18,19] This is a potential advantage over etanercept, which is not effective in treating uveitis and has potentially been associated with flares and new onset of uveitis in children with JIA.[20–22] Compared to adults, children experience a higher incidence of hypersensitivity reactions with adalimumab (6 vs 1% in adults) and antibodies to adalimumab (16 vs 5% in adults).[17]

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