Novartis today announced detailed results from the randomised, double-blind, placebo-controlled phase III PREVENT study, evaluating the efficacy and safety of Cosentyx (secukinumab) in patients with non-radiographic axial spondyloarthritis. Axial spondyloarthritis is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain.
The ongoing trial met its primary endpoint of Assessment in Ankylosing Spondylitis (ASAS40) response criteria at week 16, with 42.2% of non-radiographic axial spondyloarthritis patients treated with Cosentyx 150 mg showing a reduction in disease activity versus placebo (42.2% vs 29.2%: p<0.05), Novartis said in a press release. Statistically significant improvements in secondary endpoints were also demonstrated, including pain, mobility and health-related quality of life, the company said. The trial showed a sustained response and a safety profile consistent with previous clinical trials. No new safety signals were detected.
“The PREVENT study showed clinically significant outcomes as early as week three, and these were maintained up to one year for patients treated with Cosentyx,” said Atul Deodhar (Oregon Health & Science University, Portland, USA), lead author for the trial. “Non-radiographic axial spondyloarthritis can have a debilitating symptom burden, and if approved, this would be a welcome addition to the limited treatment options currently available to treat this condition.”
“These data strengthen the evidence for Cosentyx as a treatment option that addresses the complete axSpA disease spectrum,” said Eric Hughes, Global Development Unit head, Immunology, Hepatology & Dermatology at Novartis. “As the largest ever study of its kind in non-radiographic axial spondyloarthritis, PREVENT is an example of how we’re working to reimagine medicine for improved patient outcomes.”
The study enrolled 555 male and female adult patients with active non-radiographic axial spondyloarthritis (with onset before 45 years of age, spinal pain rated as >=40/100 on a visual analogue scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4) and who had been taking at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest dose up to four weeks prior to study start. Patients may have previously taken a TNF inhibitor (not more than one) but had an inadequate response.
Novartis recently announced it has submitted to the European Medicines Agengy (EMA) and plans to submit to the US Food and Drug Administration (FDA) for approval in non-radiographic axial spondyloarthritis. It would be the fourth indication for Cosentyx, which is backed by five-year sustained efficacy and safety data across AS, psoriasis and psoriatic arthritis.
PREVENT data are being presented as a late-breaking abstract at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP Annual Meeting; 8–13 November; Atlanta, USA).