Novartis has announced that the Phase IIIb MAXIMISE clinical trial of its Cosentyx (secukinumab) drug met primary and key secondary endpoints in patients with psoriatic arthritis (PsA).
Cosentyx is a fully-human biologic that directly inhibits interleukin-17A (IL-17A), which is associated with the inflammation and development of PsA, psoriasis (PsO), and ankylosing spondylitis (AS).
The ongoing 52-week MAXIMISE trial is being conducted to assess the safety and efficacy of the drug in the management of axial manifestations of the disease.
Results showed that 63.1% of patients treated with 300mg Cosentyx and 66.3% on a 150mg dose of the drug achieved ASAS20 at week 12.
ASAS20 is considered to have been achieved when there is an improvement of at least 20% and ten units on a 0-100 scale in at least three of the patient global assessment criteria.
Novartis noted that its drug led to rapid onset of relief as early as week four and showed a favourable safety profile that was consistent with prior studies.
The double-blind, randomised, placebo-controlled Phase IIIb trial involved a total of 498 patients with clinician-diagnosed axial involvements. Participants received subcutaneous administration of 300mg or 150mg Cosentyx given weekly for four weeks and every four weeks thereafter.
Novartis also reported new findings from the Phase III FUTURE 5 trial, where a 300mg dose of Cosentyx demonstrated no radiographic progression in nearly 90% of PsA patients over two years.
The trial was conducted to evaluate the drug’s effect on the signs and symptoms of PsA, as well as its ability to inhibit radiographic progression of the disease.
Novartis Immunology, Hepatology and Dermatology global development unit head Eric Hughes said: “These data further reinforce Cosentyx as a comprehensive treatment that's backed by over 100 studies, including five-year data across psoriasis, psoriatic arthritis and ankylosing spondylitis.”