Novartis announced that its Cosentyx (secukinumab) has achieved its primary and key secondary endpoint in the Maximise study of psoriatic arthritis (PsA).
Cosentyx is claimed to be the first and only fully-human biologic, which directly restricts interleukin-17A (IL-17A), a cornerstone cytokine engaged in the inflammation and development of PsA, psoriasis (PsO), and ankylosing spondylitis (AS).
According to the company, the ongoing 52-week phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300mg and 66.3% of Cosentyx 150mg patients achieving ASAS20 at week 12, respectively.
PsA, which is a complex disease with multiple manifestations driving patient symptoms, is estimated to affect up to 50 million people across the world.
Maximise is a double-blind, randomized and placebo-controlled phase IIIb study to assess the efficacy and safety of an immunosuppressant in the management of axial manifestations of PsA.
The company recruited 498 patients with PsA, linician-diagnosed axial involvements, spinal pain rated as >40/100 on a visual analog scale (VAS) and BASDAI >4 despite trial of at least two non-steroid anti-inflammatory drugs in the study.
Patients have been treated with subcutaneous Cosentyx 300mg or 150mg given weekly for four weeks and every four weeks thereafter.
The proportion of patients achieving an ASAS20 response with Cosentyx 300mg at week 12 was the primary endpoint of the study.
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