Novartis seeks to position Cosentyx as a first-line biologic in axial spondyloarthritis by initiating a new head-to-head study against Humira and presenting new long-term data.
By Christina Vasiliou, Senior Analyst
26 June 2016
I joined Datamonitor Healthcare in early 2014, having completed an MPhil in Bioscience Enterprise at the University of C...
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Oral presentations and posters sponsored by Novartis at the 2016 annual meeting of the European League Against Rheumatism (EULAR 2016) aimed to secure a place for the first-to-market interleukin (IL)-17A inhibitor, Cosentyx (secukinumab), early in the axial spondyloarthritis (axSpA) treatment algorithm, and to differentiate the drug from upcoming IL-inhibitors. Novartis announced the initiation of a new head-to-head study to directly compare Cosentyx versus the longstanding anti-TNF, Humira (adalimumab; AbbVie/Eisai), in patients with ankylosing spondylitis (AS). The decision was based on positive results from an indirect comparative analysis between the two drugs, which used the Matching-Adjusted Indirect Comparisons method. Data from this study suggested Cosentyx is superior to Humira in terms of Assessment of Spondyloarthritis International Society (ASAS) 20 and ASAS 40 response rates at weeks 24 and 52. If Cosentyx demonstrates superiority to Humira in the new head-to-head trial, it will theoretically be able to be positioned as a first-line biologic. However, Datamonitor Healthcare believes that physician familiarity with anti-TNF biologics and the availability of lower cost biosimilars will be Cosentyx’s greatest barrier to penetrating the first-line setting, at least initially.
Additional data from the Phase III MEASURE-1 study highlighted the positive impact Cosentyx treatment has on the long-term inhibition of radiographic progression and spinal changes in patients with active AS. Up to 80% of patients showed no radiographic progression, as measured by modified Stoke Ankylosing Spondylitis Spinal Score change from baseline through week 104. These were the first data reported on the role IL-17A inhibition in structural changes in patients with AS to date.
|ASAS 20 and ASAS 40 responses for Cosentyx and Humira at weeks 24 and 52, based on the MAIC analysis|
|Week 24||Week 52|
|ASAS = Assessment of Spondyloarthritis International Society; MAIC = Matching-Adjusted Indirect Comparisons|
|Source: EULAR, 2016|
Datamonitor Healthcare attended EULAR 2016, which explored the current rheumatology landscape, and had a strong focus on the development programs of interleukin inhibitors, novel oral small molecules, and biosimilar versions of leading anti-TNF biologics.
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