FDA-Approved Label Update: Cosentyx Inhibits Progression of Joint Structural Damage in PsA

Thursday, June 21, 2018 | FDA Approval/Clearance , Psoriasis , Product Launches and Updates , Novartis


The US FDA has approved a label update for Cosentyx® (secukinumab) from Novartis, including data that show the treatment significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA). The data will be added to the drug’s prescribing information and is effective in the US immediately.  

The update to the prescribing information is based on data from FUTURE 5, the largest Phase III study for a biologic done in PsA to date (996 patients). In the study, participants with active psoriatic arthritis (PsA) were randomized to receive Cosentyx 300mg with loading dose (LD), 150mg with LD, 150mg without LD, or placebo. All groups received Cosentyx or placebo at baseline (BL), Weeks 1, 2, 3, and 4, and then every 4 weeks. At Week 16, placebo non-responders (patients with <20% improvement from BL in tender or swollen joint counts) were switched to Cosentyx 300mg or 150mg; remaining placebo patients were switched at Week 24. The primary endpoint was ACR20 at Week 16 and the key secondary endpoint was radiographic structural progression, as measured by mTSS, assessed by two blinded readers, based on hand/wrist/foot X-rays obtained at BL, Week 16 (non-responders), and Week 24.

“While daily psoriatic arthritis symptoms can seriously affect a patient, the progressive nature of this disease should not be ignored. 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 is the first and only interleukin-17A (IL-17A) antagonist approved to treat active PsA, active ankylosing spondylitis, and moderate to severe plaque psoriasis in adults.

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