Novartis provides update on Phase III GCAptAIN study of Cosentyx® in giant cell arteritis (GCA)

Core Insights - Novartis announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) for adults with giant cell arteritis (GCA) [1][2] - The study did not show a statistically significant improvement in sustained remission at Week 52 compared to placebo [2][8] - Cosentyx demonstrated numerically better outcomes for cumulative steroid dose and steroid-related toxicity, with safety consistent with its known profile [2][8] Study Details - The GCAptAIN trial was a global Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted in 27 countries [4] - Patients were randomized into three treatment arms: Cosentyx 300 mg, Cosentyx 150 mg, or placebo, all with a glucocorticoid taper regimen [4] - The primary endpoint was to assess whether secukinumab 300 mg plus a 26-week glucocorticoid taper was superior to placebo plus a 52-week taper in achieving sustained remission at Week 52 [4] Product Information - Cosentyx is a fully human biologic that inhibits interleukin-17A, involved in inflammation for various immune-mediated diseases [5] - It is approved for multiple conditions including psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and hidradenitis suppurativa, with over 1.8 million patients treated globally since its launch in 2015 [5] - The product is supported by 10 years of real-world data demonstrating long-term safety and sustained efficacy [5] Disease Context - Giant cell arteritis (GCA) is the most common form of systemic vasculitis, primarily affecting individuals over 50 years of age [6] - GCA can lead to severe complications such as irreversible vision loss and life-threatening aortic aneurysms, necessitating prompt treatment [6]