FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of adult patients with active ankylosing spondylitis and active psoriatic arthritis.
Ankylosing spondylitis (AS) is a painful and often progressively debilitating disease, caused by spine inflammation that can cause some of the vertebrae to fuse together, making the spine less flexible and causing irreversible damage. In the United States, nearly half a million people suffer from AS, with incidence higher in men versus women.
Psoriatic arthritis (PsA) is a form of arthritis that affects some people who have psoriasis, a condition characterized by red patches of skin topped with silvery scales. The main symptoms of PsA include joint pain, stiffness and swelling, which can affect any part of the body and can range from relatively mild to severe. Up to 40% of people with PsA can suffer from joint destruction and permanent physical deformity.
Cosentyx was originally approved in January 2015 for the treatment of adult patients with moderate to severe plaque psoriasis. Cosentyx is a human monoclonal antibody (mAb) that selectively binds to interleukin-17A (IL-17A), a naturally occurring cytokine involved in inflammatory and immune responses, and inhibits its interaction with the IL-17 receptor. With the new approvals, Cosentyx is the first and only interleukin-17A (IL-17A) antagonist approved for AS, as well as moderate to severe plaque psoriasis and PsA.
“From a managed care/formulary coverage perspective, the approval of Cosentyx for active ankylosing spondylitis and active psoriatic arthritis means patients and physicians have a new treatment option for these debilitating diseases. Similar to the psoriasis indication, these FDA approvals and growing body of evidence warrant including Cosentyx on managed care and hospital formularies on par with other efficacious therapies for patients who are managing their AS and PsA," said Cathryn M. Clary, MD, head, US clinical development & medical affairs, Novartis Pharmaceuticals Corporation.
The approvals are based on the efficacy and safety outcomes from 2 AS and 2 PsA placebo-controlled Phase III studies, which included more than 1,500 adults patients diagnosed with either disease. In each of the studies, Cosentyx achieved statistically significant improvement versus placebo in the signs and symptoms of AS and PsA. Improvement was signified by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16 and a 20% reduction in the American College of Rheumatology (ACR20) response criteria at week 24. The most common adverse reactions associated with the use of Cosentyx include nasopharyngitis, diarrhea, and upper respiratory tract infections.