First Biologic Medications Approved for nr-ax Spondyloarthritis

After years of waiting, patients with non-radiographic axial spondyloarthritis (nr-axSpA) can officially be prescribed biologic medications in the US. Since the beginning of the year, three biologic medications have been approved by the FDA for people with nr-axSpA: Cimzia, Taltz, and Cosentyx. As someone who spent years waiting for diagnosis and treatment, I’m excited by the game-changing potential of nr-axSpA treatments being officially recognized.

nr-axSpA?

Spondyloarthritis (SpA) is a group of autoimmune arthritis conditions that affect the spine, other joints, and entheses. Ankylosing spondylitis (AS) is the most well-known (and easily diagnosed) type, but it requires joint damage to be visible on imaging. This leaves doctors with a conundrum: how can damage be prevented if patients can’t be diagnosed until there’s damage?

That’s where nr-axSpA comes in. Non-radiographic axial spondyloarthritis, while a mouthful, just means spinal (axial) arthritis that doesn’t show up on x-ray (non-radiographic). It’s a newer classification made by the Assessment of SpondyloArthritis International Society in 2009 to catch and treat spondyloarthritis before it progresses to AS. nr-axSpA is often considered pre-AS, although not all patients go on to have AS. Still, nr-axSpA and AS cause similar levels of pain and disability in everyday life.

Many people with nr-axSpA call their condition AS. They’re not being dishonest—many times, their doctors have to formally diagnose them with AS in order to get them effective treatment. Not to mention, if most people haven’t even heard of AS, who’s heard of nr-axSpA?

The road to FDA approval

Cimzia, a TNF-inhibitor, became the first FDA-approved biologic for nr-axSpA when it was approved in January. Cosentyx and Taltz, two IL-17 inhibitors, were both approved in the past month (June 2020). All three of these medications were FDA-approved previously to treat other autoimmune conditions, including AS, psoriatic arthritis, Crohn’s disease, and rheumatoid arthritis.

Meanwhile, biologic treatments have been approved in Europe for nr-axSpA for 8 years. Humira was first approved in Europe in 2012, and Enbrel, Cimzia, Simponi, and Cosentyx have followed. The FDA rejected Humira and Cimzia for nr-axSpA in 2013, and the makers of Cimzia have been working to get it approved since then. The FDA set guidelines for what they needed to see, and Cimzia met them.

A path to easier diagnosis?

This means more than just more treatment options. Many of us with nr-axSpA have been getting treated with biologics for years. Doctors formally diagnose us with AS so that we can get that treatment, and having officially approved medications doesn’t change our access to that. However, many of us went many years and many doctors before getting a diagnosis, because SpA is so poorly understood. Now that there’s money in selling medicine for nr-axSpA, those wealthy pharma companies will focus on educating doctors and patients about its existence.

(Have you ever noticed the ad results at the top of the page when you search a medical condition? Those “educational” sites are run by pharmaceutical companies, to drive you to the doctor or cause you to ask about their treatment. Those exist for nr-axSpA now!)

The first several doctors I went to for back pain didn’t even consider SpA, because they weren’t rheumotologists. They were orthopedists, primary care doctors, and physical therapists. As some rheumatologists speculate, more treatments being approved for nr-axSpA could mean that pharmaceutical companies spend more time educating non-rheumatologists about the condition. It could lead to quicker referrals and faster treatment!

In my case, the next doctors I saw thought it was AS but weren’t comfortable going forward once I tested negative for the HLA-B27 gene. Besides that, I was female, and my x-rays came back normal. People with nr-axSpA are more likely to be HLA-B27 negative and more likely to be female than AS patients. More awareness of nr-axSpA could help those whose doctors had previously considered AS but hit a deadend.

Getting treated for AS still leaves you with more treatment options than nr-axSpA (7 biologics for AS, 3 biologics for nr-axSpA). Still, the sudden flood of nr-axSpA treatments has me optimistic that things can change! I hope this helps others get quicker diagnosis and more effective treatment.

As always, stay safe, everyone.

-Bri

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