Positive phase III PREVENT trial of Cosentyx to treat non-radiographic axial spondyloarthritis.-Novartis

Novartis, announced positive new data from the PREVENT trial evaluating the efficacy and safety of Cosentyx (secukinumab) in patients with nr-axSpA (non-radiographic axial spondyloarthritis).

The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 16, showing a significant and clinically meaningful reduction in disease activity for patients treated with Cosentyx versus placebo. The trial demonstrated a favorable safety profile consistent with previous clinical trials. Detailed data is planned to be presented at a future scientific congress. These data add to the existing evidence supporting Cosentyx as a rapid and long-lasting comprehensive treatment, backed by evidence from over 100 studies, across axial spondyloarthritis, psoriatic arthritis and psoriatic disease, with over 250,000 patients treated worldwide .

About PREVENT : 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 greater than 40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) greater than 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). BASDAI assesses a patient�s disease activity on six measures: fatigue, spinal pain, joint pain/swelling, enthesitis, morning stiffness duration and morning stiffness severity .