The PREVENT trial revealed that secukinumab demonstrated both efficacy and a favorable safety profile for patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Positive data from the PREVENT trial were announced this week surrounding the efficacy and safety of secukinumab (Cosentyx, Novartis) in patients with nr-axSpA.
At 52 weeks, the phase 2 trial met a primary endpoint, which was the proportion of patients achieving Assessment in SpondyloArthritis International Society 40% (ASAS40) response with secukinumab versus placebo 150 mg at weeks 16 and 52. The ASAS40 response may indicate clinically significant improvements in function, health-related quality of life, and work productivity, according to Healio Rheumatology. The trial also demonstrated a sustained response and a safety profile consistent with previous clinical trials, according to the press release.
According to Spondylitis Association of America, axSpA is a form of sypondyloarthritis in which the predominant symptom is back pain that persists for more than 3 months, and where radiographic sacroiliitis might not be present through the use of X-rays. There are approximately 1.7 million patients with nr-axSpA in the United States and Europe, according to the ERG Epidemiology Database.
Secukinumab has been examined for more than 5 years through clinical data for the use in ankylosing spondylitis, psoriatic arthritis, and psoriasis.
PREVENT is a 2-year randomized, double-blind, placebo-controlled trial that enrolled 555 patients with active nr-axSpA in order to evaluate the safety and efficacy of secukinumab in patients who had been taking at least 2 different non-steroidal anti-inflammatory drugs at the highest dosage up to 4 weeks prior to study start. Investigators defined active nr-axSpA as onset before 45 years of age, spinal pain rated as 40 or more out of 100 on a visual analog scale (VAS), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 or more.
Positive 16-week PREVENT data were announced in mid-September. Novartis has submitted secukinumab to the European Medicines Agency for approval in nr-axSpA, which if approved would be the fourth indication for the drug. Novartis is currently planning an FDA submission.
"Non-radiographic axial spondyloarthritis is a chronic debilitating disease, which left untreated can have a significant impact on patients' quality of life," said Atul Deodhar, MD, professor of medicine and medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the secukinumab clinical trial program. "These positive results indicate a potential new treatment option to help patients experience relief from the signs and symptoms of their disease."