General Information

Cosentyx (secukinumab) is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

Cosentyx is specifically indicated for the following indications:

moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy

adult patients with active psoriatic arthritis

adult patients with active ankylosing spondylitis

adult patients with active non-radiographic axial spondyloarthritis (nraxSpA) with objective signs of inflammation

Cosentyx is supplied as a solution for subcutaneous injection. The recommended dose is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dose is given as 2 subcutaneous injections of 150 mg.

Clinical Results

The FDA approval of Cosentyx for plaque psoriasis was based on four multicenter, randomized, double-blind, placebo-controlled trials in 2,403 subjects (691 randomized to Cosentyx 300 mg, 692 to Cosentyx 150 mg, 694 to placebo, and 323 to a biologic active control) 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12, and who were candidates for phototherapy or systemic therapy. In all trials, the endpoints were the proportion of subjects who achieved a reduction in PASI score of at least 75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the Investigator’s Global Assessment modified 2011 (IGA). In these studies, Cosentyx met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator's Global Assessment modified 2011 (IGA) 0/1 responses, showing significant skin clearance at Week 12.

The FDA approval of Cosentyx for active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS) was based on the efficacy and safety outcomes from two AS and two PsA placebo-controlled Phase III studies which included more than 1,500 adult patients with either AS or PsA. In the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA, as measured 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, respectively.

The FDA approval of Cosentyx for active non-radiographic axial spondyloarthritis was based on the Phase 3 PREVENT trial, which demonstrated the efficacy of Cosentyx in active non-radiographic axial spondyloarthritis (nr-axSpA), which is part of the axial spondyloarthritis (axSpA) disease spectrum. In that study, Cosentyx met the primary endpoint achieving statistically significant improvements in the signs and symptoms of nr-axSpA.

Mechanism of Action