Novartis has reported additional data from the ongoing Phase III PREVENT clinical trial of Cosentyx (secukinumab), where all primary and secondary endpoints were met in patients suffering from non-radiographic axial spondyloarthritis (nr-axSpA).
Cosentyx is a fully-human biologic designed for the direct inhibition of interleukin-17A (IL-17A), which is associated with psoriatic arthritis (PsA), psoriasis (PsO) and ankylosing spondylitis (AS).
The two-year randomised, double-blind, placebo-controlled PREVENT trial evaluated the safety and efficacy of Cosentyx in 555 adults with active nr-axSpA, including 501 biologic naïve subjects.
It enrolled patients on the highest dose of a minimum of two non-steroidal anti-inflammatory drugs (NSAIDs) up to four weeks before initiation.
Participants received 150mg subcutaneous Cosentyx with or without a loading dose or placebo.
The primary endpoints are the proportion of subjects experiencing an ASAS40 response, determined as a decrease in disease activity, with Cosentyx at weeks 16 and 52.
The trial’s secondary endpoints included the change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP).
ASAS40 is considered to have been achieved when there is an improvement of at least 40%, as well as a minimum of ten units on a 0–100 scale in three or more of the patient global assessment, pain assessment, function and inflammation.
Meanwhile, BASDAI examines a patient’s disease activity on fatigue, spinal pain, joint pain/swelling, enthesitis, as well as morning stiffness duration and severity.
The Phase III trial demonstrated a significant and clinically meaningful decrease in disease activity at week 16 when treated with Cosentyx compared to placebo.
The safety profile observed during the study was consistent with previous trial data.
Novartis global drug development head and chief medical officer John Tsai said: “These study results for Cosentyx build on our long-standing experience in ankylosing spondylitis and are a step toward a new treatment option that could allow patients to realise relief much earlier in axial spondyloarthritis.
“If approved, this would be the fourth indication for Cosentyx.”
The drug has been used to treat more than 250,000 patients with axial spondyloarthritis, psoriatic arthritis and psoriatic disease.