The Food and Drug Administration (FDA) has approved updated labeling for Cosentyx (secukinumab; Novartis) that includes data demonstrating that the drug slows the progression of joint structural damage in patients with active psoriatic arthritis.
The update is based on data from the Phase 3 FUTURE 5 study (N=996) which evaluated Cosentyx versus placebo in patients with active psoriatic arthritis. Patients received Cosentyx or placebo at baseline but were switched to Cosentyx at Week 16 if they were placebo-non-responders; the remaining placebo patients were switched at Week 24. The primary endpoint of the study was ACR20 at Week 16; a key secondary endpoint was radiographic structural progression measured by van der Heijde modified Sharp total score (mTSS).
Results showed that compared with placebo, treatment with Cosentyx significantly inhibited radiographic structural progression at Week 24.
“The joint damage that often results from having the disease over time can potentially be permanent,” said Marcia Kayath, Head US Clinical Development and Medical Affairs, Novartis. “Now physicians and their patients with psoriatic arthritis can be confident that Cosentyx not only offers significant symptom relief, but also helps slow the progression of the disease.”
Cosentyx, a human interleukin-17A antagonist, is approved for the treatment of: moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy; adults with active psoriatic arthritis; and adults with active ankylosing spondylitis.
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