Novartis has reported positive results from the Phase III MEASURE 1 extension trial of Cosentyx (secukinumab) to treat patients with active ankylosing spondylitis (AS).
Approved in more than 70 countries for AS and psoriatic arthritis (PsA), Cosentyx is a fully human interleukin-17A (IL-17A) inhibitor.
The results showed improvement in the signs and symptoms of AS at three years, which is consistent with previous data from the Phase III FUTURE 1 trial in active PsA patients.
Additionally, a two-year post-hoc analysis of the Phase III FUTURE 2 trial with Cosentyx in PsA patients showed quick pain relief at week three, which sustained until two years.
Novartis drug development global head and chief medical officer Vas Narasimhan said: "This data reconfirms that Cosentyx provides patients with long-lasting relief from the symptoms of ankylosing spondylitis and psoriatic arthritis, as well as now demonstrating rapid pain relief from psoriatic arthritis.”
The multi-centre, randomised, placebo-controlled MEASURE 1 trial evaluated the efficacy and safety of Cosentyx in 371 patients for a period of two years, which was then extended to additional three years.
Initially, an intravenous loading dose of 10mg/kg every two weeks was administered for the first four weeks of treatment and later switched to monthly subcutaneous maintenance dosing of 75mg and 150mg.
The trial’s primary endpoint was superiority of Cosentyx at week 16 in the proportion of patients achieving a minimum of 20% improvement in the ASAS 20 response criteria.
The randomised, double blind, placebo-controlled FUTURE 1 trial assessed the long-term safety, tolerability and efficacy of the product over two years in 606 patients with same dosing regimen as MEASURE 1.
In a setting similar to FUTURE 1, the FUTURE 2 trial investigated the long-term efficacy, safety and tolerability of subcutaneous 5mg, 150mg and 300mg of Cosentyx in 397 patients.
Image: Magnetic resonance images of fingers of a patient with psoriatic arthritis. Photo: courtesy of Fiona McQueen, Marissa Lassere and Mikkel Østergaard.
