Review of Biologics in Children With Rheumatic Diseases

Shabina Habibi; Athimalaipet V Ramanan


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

In This Article


An open-label study on five patients with FCAS treated with rilonacept demonstrated long-term sustained benefit and safety.[73] Improvement in clinical and laboratory measures of inflammation was observed. A recent randomized, double-blind placebo-controlled trial in patients with FCAS or MWS was published.[74] This was a two part study, which lasted 6 weeks and 18 weeks. In part one, patients were treated with a loading dose of 320-mg rilonacept or placebo administered subcutaneously, followed by weekly injections of 160-mg rilonacept or placebo for 6 weeks. This was followed by part two, which again consisted of two parts. In part A, patients were given weekly rilonacept 160 mg for 9 weeks in a single-blinded manner, followed by part B where they were treated with rilonacept in the same dose, or placebo in a double-blinded manner for a further 9 weeks. Forty-four patients completed both the studies. At the end of 6 weeks, rilonacept was found to be significantly superior to placebo in reducing symptoms and flare rates. In Phase II, patients who received rilonacept in Phase I continued to demonstrate benefit, and those who had received placebo and were switched to rilonacept demonstrated a rapid improvement in symptoms and decrease in inflammatory markers. During part B, rilonacept was superior to placebo in maintaining clinical and inflammatory response. Safety and tolerability were generally favorable. This drug has been approved by the FDA for the treatment of FCAS and MWS in patients over 11 years of age.


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