Basel - Novartis, a leader in rheumatology and immuno-dermatology, today announced the European Commission (EC) has approved Cosentyx (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

'This approval of Cosentyx for non-radiographic axial spondyloarthritis means clinicians across Europe now have an effective new treatment option to help patients gain relief from the burden of this painful, debilitating disease and achieve a better quality of life both at home and at work,' said Atul Deodhar, MD, Professor of Medicine and Medical Director of Rheumatology Clinics at Oregon Health & Science University, USA, and an investigator in the PREVENT clinical trial.

The approval is based on data from the Phase III PREVENT study, in which Cosentyx met the primary endpoint. In the study, 41.5% of nr-axSpA patients treated with Cosentyx 150 mg showing a significant and clinically meaningful reduction in disease activity versus placebo (41.5% vs 29.2%: p=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 a TNF inhibitor (not more than one) but had an inadequate response. Of the 555 patients enrolled in the study, 501 (90.3%) 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)14.

The primary endpoints are the proportion of patients achieving an ASAS40 response with Cosentyx 150 mg at Weeks 16 and 52 in TNF-naive patients. Secondary endpoints include among others change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP)14.

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