Blog Big Molecule Watch September 06, 2019

Biologic Developments in the Treatment of Axial Spondyloarthritis

In August, the American College of Rheumatology released updated guidelines for the treatment of ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA), the two types of axial spondyloarthritis. The new recommendations suggest that patients use TNF inhibitors (Humira, Cimzia and Enbrel) as first-line therapy, followed by IL-17 inhibitors (Cosentyx and Taltz) as second-line therapy. For years the primary treatment for AS and nr-axSpA has consisted of a regimen of NSAIDs and exercise.

Taltz (ixekizumab), marketed by Eli Lilly, was FDA-approved for the treatment of AS on August 26, 2019. This is the third indication for Taltz, following its approval for the treatment of moderate to severe plaque psoriasis in 2016 and the treatment of psoriatic arthritis in 2017.

On August 30, 2019, Innovent Biologics announced positive results from phase III clinical trials comparing the safety and efficacy of their biosimilar candidate IB303 (adalimumab) to the reference drug Humira in patients with AS. The trial was a multi-center, randomized, double-blind, parallel-controlled trial involving 438 AS patients, making it the first large-scale head-to-head phase III clinical trial comparing a biosimilar and adalimumab in AS patients.

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