Novartis announced additional positive data from the PREVENT trial, evaluating the efficacy and safety of Cosentyx® (secukinumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 52, showing a significant and clinically meaningful reduction in disease activity for patients treated with Cosentyx versus placebo. The trial demonstrated a sustained response and a safety profile consistent with previous clinical trials. No new safety signals were detected.
Positive 16-week PREVENT data were announced mid-September and submitted to EMA for approval in nr-axSpA. These data add to the five-years of clinical data supporting the long-term efficacy and safety of Cosentyx across ankylosing spondylitis, psoriatic arthritis and psoriasis.
"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."
"These data are encouraging for people living with nr-axSpA, where there are only limited treatment options available," said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer for Novartis. "It's a great example of how we're working to reimagine medicine to help patients realize early relief from this disease."
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Axial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain. The axSpA disease spectrum includes ankylosing spondylitis (AS), in which joint damage is generally visible on x-ray, and non-radiographic axial spondyloarthritis (nr-axSpA), in which joint damage is not visible on x-ray. Both parts of the disease spectrum have a similar symptom burden, including nocturnal pain, fatigue, morning stiffness and functional disability14. If left untreated, axSpA could impair activity, lead to lost work time and have a significant impact on quality of life.
PREVENT is an ongoing two-year randomized, double-blind, placebo-controlled Phase III study (with a two-year extension phase) to investigate the efficacy and safety of Cosentyx, in patients with active nr-axSpA. The study enrolled 555 male and female adult patients with active nr-axSpA (with onset before 45 years of age, spinal pain rated as ≥40/100 on a visual analog 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 4 weeks prior to study start. Patients may have previously taken an TNF inhibitor (not more than one) but had had an inadequate response. Of the 555 patients enrolled in the study, 501 (90%) were biologic naive. Patients were allocated to one of three treatment groups: Cosentyx 150 mg subcutaneously with loading dose (Induction: 150 mg Secukinumab subcutaneously weekly for 4 weeks, then maintenance with 150 mg Secukinumab monthly); Cosentyx 150 mg no loading dose (150 mg Secukinumab subcutaneously monthly), or placebo (induction of subcutaneously weekly for 4 weeks, followed by maintenance of once-monthly).
The primary endpoints are the proportion of patients achieving an ASAS40 response with Cosentyx 150 mg at weeks 16 and 52. Secondary endpoints include change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP).
ASAS40 is achieved when there is a measure of an improvement of at least 40% and an improvement of at least 10 units on a 0–100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), and Inflammation (morning stiffness severity and duration) and no worsening in the remaining domains. BASDAI assesses a patient's disease activity on six measures: fatigue, spinal pain, joint pain/swelling, enthesitis, morning stiffness duration and morning stiffness severity.