Novartis’ Cosentyx demonstrates positive Phase III results in 16-week non-radiographic axial spondyloarthritis study

GlobalData Healthcare 26th September 2019 (Last Updated September 26th, 2019 12:05)

The ongoing Phase III study met its primary endpoint of patients achieving a 40% improvement in symptoms.

Novartis’ Cosentyx demonstrates positive Phase III results in 16-week non-radiographic axial spondyloarthritis study

On 17 September, Novartis announced that non-radiographic axial spondyloarthritis (nr-axSpA) patients treated with Cosentyx (secukinumab) demonstrated positive 16-week results in the PREVENT trial. 

The ongoing Phase III study met its primary endpoint of patients achieving a 40% improvement in symptoms when measured by the Assessment of SpondyloArthritis International Society response criteria (ASAS40) at Week 16, showing a significant and clinically meaningful reduction in disease activity, such as severity and duration of morning stiffness and pain, for patients treated with Cosentyx versus placebo. 

All secondary endpoints, such as improvements in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Quality of Life scores (ASQoL), were also met. 

With the announcement of 52-week data expected by the end of this year, GlobalData anticipates Cosentyx to gain approval in nr-axSpA in the US and EU in 2022.

The PREVENT trial is an ongoing, two-year, randomised, double-blind, placebo-controlled Phase III study (with a two-year extension phase) to investigate the efficacy and safety of Cosentyx in patients with active nr-axSpA. 

The study enrolled 555 patients, all of whom had failed to see improvements in symptoms with at least two different non-steroidal anti-inflammatory drugs (NSAIDs), and 90% of whom were biologic treatment-naïve. The drug is expected to gain approval since it has already been approved in ankylosing spondylitis (AS), which is part of the axial spondyloarthritis (axSpA) disease spectrum, like nr-axSpA. Cosentyx is already approved for AS, psoriasis, and psoriatic arthritis. 

While gaining another indication for Cosentyx would be advantageous for Novartis, Cosentyx is expected to be the third treatment approved for treating nr-axSpA in the US after the 2019 approval of UCB’s Cimzia (certolizumab pegol) and the expected 2020 approval of Eli Lilly’s Taltz (ixekizumab), which produced positive Phase III results in April 2019. 

Moreover, Cosentyx may struggle to differentiate itself from Taltz as they both share the same mechanism of action in targeting interleukin (IL)-17A. Cimzia will also provide fierce competition as it targets tumour necrosis factor-alpha (TNFα), placing it a step ahead of Cosentyx and Taltz in most treatment algorithms across the world. Once Cimzia’s constraining patent expires in 2024, Cosentyx will also have to contend with the influx of cheaper certolizumab pegol biosimilars. 

In Europe, many other anti-TNF biologics, such as AbbVie’s Humira (adalimumab), already have approval for the treatment of nr-axSpA, so the decision of which treatment to use may be even more competitive than in the US.

However, Novartis will have plenty of experience navigating many of these issues, since Cosentyx gained approval in AS back in 2015. As there will only be three treatments available for nr-axSpA in the US by 2022, Novartis has the opportunity to effectively market its drug. Because it beat Taltz to the market in AS, psoriasis, and psoriatic arthritis, many rheumatologists will be more comfortable prescribing Cosentyx, and its efficacy in nr-axSpA will likely be similar to its efficacy in AS.

Related report

GlobalData (2018). Axial Spondyloarthritis – Market Analysis and Forecasts to 2028, to be published