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.
The major secondary endpoint was ASAS20 response with Cosentyx 150mg at week 12 after superiority of Cosentyx 300mg was established, said the company.
The prescription medication was studied in the persistent manifestations of psoriasis, namely nails, scalp, palms and soles, as well as PsA and AS.
Spain’s Hospital Clínico Universitario de Santiago de Compostela rheumatology head Dr Antonio Mera Varela said: “This is the first time we’ve seen the efficacy of a biologic in the axial manifestations of psoriatic arthritis at 12 weeks.
“As a physician, it’s highly important that there is something that can help manage all aspects of my patients’ psoriatic arthritis, including inflammation of the spine, joints, enthesitis, dactylitis and psoriasis of the skin and nails.”