The approval is based on the phase 3 PREVENT trial, presented at the European E-Congress of Rheumatology 2020 (EULAR 2020) virtual meeting.
The US Food and Drug Administration (FDA) has approved secukinumab (Cosentyx) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adults.
The approval is based on the phase 3 PREVENT trial, presented at the European E-Congress of Rheumatology 2020 (EULAR 2020) virtual meeting, involving 555 adults with active nr-axSpA who were biologic-treatment naïve or had an inadequate response or were intolerant to an anti-tumor necrosis factor-α therapy (anti-TNFs).
The study drug met the primary endpoint of the trial in achieving statistically significant improvements when compared to placebo in the signs and symptoms of nr-axSpA, measured by at least a 40% improvements in the Assessment of Spondyloarthritis International Society (ASAS40) response criteria in biologic-naïve individuals at week 52.
Patients also showed improvement in both load and without load arms compared to placebo-treated patients at week 16 in health-related quality of life, measured by the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire (Least Squares mean change: Week 16: -3.5 and -3.6 vs -1.8, respectively).
There are currently an estimated 2.7 million patients in the US suffering from axSpA, but experts believe it is often underdiagnosed.
General health status and quality of life was assessed by the Short Form health survey (SF-36) and at Week 16, patients treated with secukinumab showed greater improvement from baseline in the SF-36 physical component summary (PCS) score and in the mental component summary (MCS) score
“The results from the PREVENT trial show that there was a significant reduction in disease activity for patients treated with Cosentyx versus placebo,” 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, said in a statement. “This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis.”