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FDA approval for the secukinumab (Cosentyx, Novartis) for non-radiographic axial spondyloarthritis was based on results from the PREVENT trial, which showed significant reduction in disease activity.
The FDA has approved secukinumab (Cosentyx, Novartis) for treating active non-radiographic axial spondyloarthritis (nr-axSpA), according to a news release.
Though largely underdiagnosed, research estimates that 2.7 million individuals are living with axSpA in the United States. The disease is characterized by inflammatory arthritis of the spine associated with chronic inflammatory back pain. AxSpA causes significant daily physical limitations, as well as limitations in leisure activities.
Secukinumab is the first and only fully human biologic that directly inhibits the key cytokine interleukin-17A (IL-17A), which produces inflammation and development of psoriatic arthritis, moderate-to-severe plaque psoriasis, ankylosing spondylitis, as well as nr-axSpA. The approval serves as secukinumab’s fourth indication.
The study upon which FDA approval was based was PREVENT: a 2-year, randomized, double-blind, placebo-controlled phase 3 study with a 2-year extension phase that evaluated the safety and efficacy of secukimab in patients with active nr-axSpA. A total of 555 patients with active disease, with onset prior to 45 years of age, who had been receiving at least 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) at the highest dose up to 4 weeks before the study began, were allocated to 1 of 3 treatment groups: secukinumab 150 mg subcutaneously with loading dose, secukinumab 150 mg with no loading dose, or placebo.
Assessment of data found that nr-axSpA patients treated with secukinumab demonstrated improvement in both load and without load arms compared with placebo arm at week 16 in relation to measured health-related quality of life through the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. Participants treated with the drug showed greater improvement from baseline as well.
Investigators found safety profile data consistent with previous clinical trials, and no new safety signals were detected.
“The results from the PREVENT trial show that there was a significant reduction in disease activity for patients treated with Cosentyx versus placebo,” said Atul Deodhar, MD, professor of medicine and medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the PREVENT clinical trial. “This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis.”