Tuesday, 19 Mar 2019

You are here

Cosentyx Gets Radiographic Protection Indication for Psoriatic Arthritis

Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of new evidence that Cosentyx® (secukinumab) 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. Cosentyx is the first interleukin-17A (IL-17A) antagonist approved to treat active PsA, active ankylosing spondylitis, and moderate to severe plaque psoriasis in adults.  More than 74,000 patients in the US have been prescribed Cosentyx in the post-marketing setting across all indications since launch.

PsA affects an estimated 2 million people in the US and can lead to irreversible joint damage and disability caused by years of inflammation.

Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.1

The FUTURE 5 study included 996 active psoriatic arthritis (PsA) randomized to receive secukinumab 300 mg with loading dose (LD), 150 mg with LD, 150 mg without LD, or placebo. At Week 16, placebo non-responders were switched to SEC 300 mg or 150 mg; remaining placebo patients were switched at Week 24. The percentage of patients with no disease progression (defined as a change from baseline in mTSS of less than or equal to 0.0) from randomization to Week 24 was 75.7%, 70.9%, and 76.5% for Cosentyx 150 mg without load, 150 mg, 300 mg, respectively versus 68.2% for placebo.

 

 

 

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

Add new comment

More Like This

Biologic Agents have Equal Efficacy in Enthesitis and Dactylitis

A systematic review has shown that TNF inhibitors (TNFi) are equaled in efficacy by other biologic agents (ustekinumab, secukinumab, and ixekizumab) in psoriatic arthritis (PsA) patients with in dactylitis and enthesitis.

The literature review analyzed datafrom randomized controlled trials (RCTs) with TNFi (infliximab, golimumab, adalimumab), antiinterleukin- 12/23 (ustekinumab) and anti-interleukin-17 (secukinumab, ixekizumab).

Dual IL-17 Inhibitor in Psoriasis Succeeds

Patients with moderate-to-severe plaque psoriasis attained durable complete and near-complete responses for more than a year with a dual inhibitor of interleukin (IL)-17, data from a randomized trial showed. 

AAD/NPF Guidelines on Biologic Use in Psoriasis

Menter and colleagues from the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) have published their expert consensus guidelines for the use of biologics in psoriasis.

Dermatology Guidelines for Psoriatic Comorbidities

The JAAD has published joint guidelines from the American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) on the approach, management and dermatolgist roles for select comorbid conditions. 

Early TNF inhibition in Early Psoriatic Arthritis

A small, double-blind, randomised, placebo-controlled trial in early psoriatic arthritis (PsA) has shown that first-line use of golimumab and methotrexate (MTX) is superior to MTX alone in inducing remission in PsA.