Experts Update Treatment Guidelines for Axial Spondyloarthritis, a Type of Inflammatory Arthritis
Recommendations to manage ankylosing spondylitis and nonradiographic axial spondyloarthritis address new biologics, imaging practices, and the use of biosimilars.
In recent years, novel treatments for arthritis have improved disease management for more and more patients.
Many of the new therapies have benefited those with axial spondyloarthritis, a type of arthritis that affects the sacroiliac joints (the joints that connect the bottom of the spine to the pelvis) or the vertebrae (the bones of the spine).
To help patients and doctors navigate this world of new therapies and make optimal decisions regarding treatments, the American College of Rheumatology (ACR) updated its Recommendations for the Treatment of Ankylosing Spondylitis (AS) and Nonradiographic Axial Spondyloarthritis (nr-axSpA). AS and nr-axSpA are the two subtypes of axial spondyloarthritis.
Advice on the Use of New Medications and Imaging Tests for AS and Nr-AxSpA
Released this August, four years after the previous guideline, this update addresses considerations regarding new medications, the use of biologics and biosimilars in people with the conditions, and best practices for imaging (MRI and radiographs). The ACR published the new recommendations in partnership with the Spondylitis Association of America (SAA) and the Spondyloarthritis Research and Treatment Network (SPARTAN).
“We hope this new information will help get patients on an effective treatment faster and ultimately improve patients’ health status and quality of life,” says Michael Ward, MD, MPH, a researcher at the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the principal investigator of the guidelines.
Help for Millions of People Living with Arthritis
Inflammatory arthritis is hard to diagnose. When you add together the officially diagnosed and those who have symptoms but are undiagnosed, more than one-third of Americans — or 91 million people — may have arthritis, according to the Arthritis Foundation. Of those, about 3 percent or as many as 2.7 million individuals, may be affected by axial spondyloarthritis, according to data from the Spondylitis Association of America.
Lower Back Pain and Aching Hips Are Symptoms of Axial Spondyloarthritis
With the subtype nr-axSpA, the damage is not visible by X-ray, but more sensitive MRI (magnetic resonance imaging) may detect evidence of disease. For some with nr-axSpA, the disease can develop into AS, which can be clearly seen on an X-ray. Many can have AS, however, without ever having nr-axSpA, and those with nr-axSpA may never get AS.
With AS, the disease can advance to a point where the sacroiliac joints and the vertebrae become fused — a condition doctors call "bamboo spine." Either type of axial spondyloarthritis can be painful and disabling, but new treatments have increasingly offered potential relief to patients.
“Over the past five years, there has been a great deal of interest and a great amount of study of new medications to treat AS — and we hope this trend will continue,” says Dr. Ward.
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Advice for the Use of Biologics for Treating Axial Spondyloarthritis
For decades, the first mainstay of treatment for axial spondyloarthritis has been nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen, indomethacin, aspirin, and ibuprofen, according to a study published in Advances in Pharmacological Sciences in January 2019.
“The vast majority of patients do well on a regimen of daily NSAIDs and exercise,” says Ward.
If that combination isn’t sufficient to control symptoms, these recommendations strongly advise patients to turn to TNF inhibitors. These drugs are a type of biologic (protein-based medications created from living cells). Also known as anti-TNF drugs, they include Humira (adalimumab), Cimzia (certolizumab pegol), and Enbrel (etanercept).
If TNF inhibitors aren’t effective, the treatment recommendations suggest that patients try the next class of medications, called IL-17 inhibitors. These drugs are relatively new. The U.S. Food and Drug Administration (FDA) approved the IL-17 inhibitor Cosentyx (secukinumab) in 2016 and the agency just green-lighted the IL-inhibitor Taltz (ixekizumab) in August for the treatment of adults with active ankylosing spondylitis.
Ward and the committee members made a conditional recommendation that TNF inhibitors be used as treatment first over the IL-17 inhibitors secukinumab, ixekizumab, or Xeljanz (tofacitinib).
“The committee decided that the use of TNF inhibitors should be done first, simply because of the longer track record,” says Ward. “We have 20 years of experience using these medications, we know the types of responses to expect, and we know potential side effects as well.”
Ward and colleagues also advised using secukinumab and ixekizumab over tofacitinib because tofacitinib is not yet FDA-approved for treatment of AS.
“If people don’t have an adequate response to at least two different TNF inhibitors or if they don’t have even an initial response to the first TNF inhibitor, they might consider going to the IL-17 inhibitor in those two situations,” says Ward.
Direction Regarding Biosimilars (Copies of Biologics)
Biosimilars are almost identical copies of biologics. They’ve very similar but not exactly the same.
“These antibodies are proteins and there’s never going to be two proteins that are going to be manufactured the same,” says Ward. “There are going to be all sorts of minor biochemical variations.”
The biosimilars can be less expensive than the biologics, and sometimes an insurance company will insist that a patient take the biosimilar over the biologic.
The committee strongly recommended that adults with stable AS who start on a biologic not be mandated to switch to a biosimilar.
“If people are going along their merry way doing fine on one medication, the committee felt they should be able to continue along on that medication without the insurance company interfering,” says Ward.
Jason Faller, MD, a rheumatologist affiliated with Lenox Hill Hospital in New York City who was not part of this research, compares the biologics to a brand-name laundry detergent and the biosimilars to a store brand.
“Even though they may be almost the same thing, nobody wants to experiment,” he says. “If you’re doing fine on one medication, why rock the boat?”
When Needed, Imaging Should Be Limited
Recommendation authors indicated that some doctors follow a practice of scheduling regular X-rays with patients who have nr-axSpA.
According to their research, the scientists suggest that this should not be a standard approach and imaging should not be done unless there is a reason, such as an acute change in symptoms.
“The radiographic changes in this disease are so slow to occur that there is no regular interval at which we say yes it’s going to make a difference to take new pictures,” says Dr. Faller.
“I would only take new pictures, personally, at a point where I thought that somebody was having a problem because they are complaining of something new or different or if I am questioning whether their current therapy is working.”
Treatments for Axial Spondyloarthritis Are Getting Better
Although the development of more medications may require more expert advice from doctors and researchers in order for people to make sound decisions regarding therapy, the outlook for axial spondyloarthritis treatment continues to improve.
“I think the fact that we have more drugs with more mechanisms of action is expanding our ability to treat those patients who have been left off the wagon, so to speak,” says Faller. “There are some patients who haven’t tolerated certain classes of drug, so new classes of drugs are giving us the option to treat those patients.”