FDA Approved

If you’ve been diagnosed with axial spondyloarthritis (axSpA), an inflammatory type of arthritis that mostly impacts the spine, your doctor might have told you that you have the “radiographic” or “non-radiographic” form. The key difference is that only those with radiographic axSpA — also called ankylosing spondylitis — have joint damage that is visible on imaging tests like X-rays.

While some doctors used to consider the non-radiographic form of axSpA to be less serious, recent research has called that notion into question. Earlier this year, a study published in the Annals of the Rheumatic Diseases found that people with non-radiographic axSpA (nr-axSpA) generally had the same degree of symptoms and complications as those who had radiographic proof of joint damage. Yet many newer targeted drugs are only approved for people with the radiographic version of axSpA; as a result, those with nr-axSpA are often unable to access treatments that might help them.

Thankfully, this is starting to change. Last spring, the U.S. Food and Drug Administration (FDA) approved Cimzia (certolizumab pegol) for use in people with nr-axSpA. Cimzia is a type of biologic medication that targets an immune system protein called tumor necrosis factor (TNF) to reduce inflammation.

Earlier this month, the FDA gave the green light to the first interleukin inhibitor, ixekizumab (Taltz) for treatment of nr-axSpA. This approval follows a Phase 3 study that found a significant portion of nr-axSpA patients who used Taltz had improvements in their pain, inflammation, and functioning. Taltz was FDA-approved for ankylosing spondylitis(radiographic axSpA) last fall.

Taltz works by targeting the immune system protein interleukin 17A (IL-17A), an inflammatory cytokine that is elevated in people with axSpA as well as other autoimmune conditions. The drug was initially approved for plaque psoriasis and has since garnered approval for psoriatic arthritis, as well as AS.

Unlike non-steroidal anti-inflammatory drugs (NSAIDs), which are generally the first line of treatment for axSpA and treat pain as well as inflammation, TNF and interleukin inhibitors like Cimzia and Taltz have the potential to slow down the progression of the disease.

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Eli Lilly, which manufactures ixekizumab (Taltz), is a corporate sponsor of the Global Healthy Living Foundation.

A History of Helping Adults Across Six Chronic Inflammatory Diseases. Cimzia.com
https://www.cimzia.com/cimzia-history#:~:text=First%20approved%20by%20the%20FDA,plaque%20psoriasis%20and%20non%2Dradiographic.

FDA Expands Approval of Ixekizumab for Nonradiographic Axial Spondyloarthritis. Healio Rheumatology. June 1, 2020.
https://www.healio.com/news/rheumatology/20200601/fda-expands-approval-of-ixekizumab-for-nonradiographic-axial-spondyloarthritis.

Lilly’s Taltz (ixekizumab) is the First IL-17A Antagonist to Receive U.S. FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA). PR Newswire. Eli Lilly and Company. June 1, 2020. https://www.prnewswire.com/news-releases/lillys-taltz-ixekizumab-is-the-first-il-17a-antagonist-to-receive-us-fda-approval-for-the-treatment-of-non-radiographic-axial-spondyloarthritis-nr-axspa-301068073.html.

Taltz Approval History. Drugs.com. https://www.drugs.com/history/taltz.html.