Based on the safety and efficacy outcomes from the PREVENT phase 3 study, the FDA has approved secukinumab (Cosentyx) from Novartis for the treatment of active nonradiographic axial spondyloarthritis.
Based on the safety and efficacy outcomes from the PREVENT phase 3 study, the FDA has approved secukinumab (Cosentyx) from Novartis for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA). The results of PREVENT were presented at the European Congress of Rheumatology of the European League Against Rheumatism.
Secukinumab was already approved for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and active ankylosing spondylitis. It was approved for nr-axSpA by the European Union in April 2020.
The PREVENT study enrolled 555 patients with active nr-axSpA who had taken at least 2 nonsteroidal anti-inflammatory drugs but were biologic-naïve. Patients received either placebo, secukinumab 150 mg with loading dose, or secukinumab 150 mg without loading dose. Patients in the loading-dose group received 150-mg secukinumab subcutaneously weekly for 4 weeks followed by maintenance with 150 mg monthly; the no-loading-dose group received 150-mg secukinumab subcutaneously monthly; and the placebo group received induction subcutaneously weekly for 4 weeks followed by once-monthly maintenance.
The trial met its primary end point of a 40% improvement in the Assessment of Spondyloarthritis International Society domains at week 16 (41.5%) versus placebo (29.2%; P <.05) and at week 52 (35.4% vs 19.9%; P <.05).
“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 nonradiographic axial spondyloarthritis.”
Secukinumab 150 mg, either with loading dose or no loading dose, significantly improved secondary end points indicating improvements in pain, mobility, and health-related quality of life. Secukinumab significantly reduced sacroiliac joint bone marrow edema score by MRI (—1.68 for loading dose and –1.03 for no loading dose) compared with placebo (–0.39; P = .0197 and .026).
“There is a need for additional treatment options. Having a new treatment option for the axSpA community is truly encouraging," said Cassie Shafer, CEO of the Spondylitis Association of America (SAA). “Helping reduce the burden on people living with nonradiographic axial spondyloarthritis by improving symptoms that affect their daily lives remains a critical focus for the SAA.”
Braun J, Blanco R, Dokoupilova E, et al. Secukinumab 150 mg significantly improved signs and symptoms of non-radiographic axial spondyloarthritis: 52-week results from the phase III PREVENT study. Presented at: EULAR 2020; June 3-6, 2020; Abstract OP0106. https://ard.bmj.com/content/79/Suppl_1/69