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


A multicenter randomized, double-blind, placebo-controlled trial of canakinumab 150 mg every 8 weeks, in which patients with CAPS having the NLRP3 mutation was recently published.[75] Patients included those who had received previous anakinra (49%) or rilonacept or those who had flared on canakinumab (26%). Part one was an open-label phase lasting for 8 weeks; part two was a randomized placebo-controlled phase for 24 weeks; and part three was an open-label extension phase, in which all patients received canakinumab. Of the 35 patients enrolled in Phase I, complete response to a single dose was observed in 34 (97%). During the double-blind phase, all the patients who received canakinumab maintained remission, whereas 81% receiving placebo flared. CRP and serum amyloid A levels remained low in those on canakinumab, in contrast to those on placebo. A total of 97% of patients who entered Phase III had sustained clinical and biochemical remission on canakinumab. Suspected infections were more prevalent in those on canakinumab; however, the infections were not serious.

Canakinumab has been FDA approved for the treatment of FCAS and MWS in adults and children who are 4 years or older.


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