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Carol Eustice

FDA Approves Ilaris (canakinumab) for Systemic Juvenile Idiopathic Arthritis

By May 12, 2013

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On May 10, 2013, the U.S. Food and Drug Administration (FDA) approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis in patients aged 2 years and older. Ilaris, a fully human monoclonal antibody developed by Novartis, is the first interleukin-1 (IL-1) beta inhibitor approved for systemic juvenile idiopathic arthritis and the only treatment approved specifically for the disease that is administerd as a once-monthly subcutaneous injection. Systemic juvenile idiopathic arthritis, which is considered the most severe form of juvenile arthritis, affects 5-15 children per 100,000 in the United States.

The FDA approval was based on two Phase III trials. Results from the first study showed that, by day 15, 84% of study participants treated with one subcutaneous dose of Ilaris achieved the primary endpoint of ACR 30 (30% improvement in symptoms as defined by the American College of Rheumatology) compared to 10% of participants receiving placebo. In the second study, 92 of 128 patients attempted corticosteroid tapering; 62% substantially reduced their use of corticosteroids while 46% were able to discontinue corticosteroids. Ilaris also reduced the recurrence of flares in the second study.

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Comments
May 21, 2013 at 7:34 am
(1) Lucinda says:

It was back to the injections for Crowley, and it was during these injections
that we found out that Crowley likes to sing “Changes” while chained up and watches HBO (“Band of Brothers,”
“The Pacific,” “Girls”) and dropped a line that surprised even himself:
“I just want to be loved. Of course, it is up to you what style or colour dress you wear as trends, cultures and families differ hugely. Men only respect Women that have goals and standards set for themselves.

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