Cartoon shows file folders that read "FDA Approved"
Credit: Tatiana Ayazo

People with ankylosing spondylitis (AS), a form of inflammatory arthritis that primarily impacts the spine and the joints that connect it to the pelvis, now have a new treatment option to consider. On April 29th, the U.S. Food and Drug Administration (FDA) greenlighted upadacitinib (Rinvoq) for the treatment of this condition. 

Upadacitinib is a Janus kinase (JAK) inhibitor, a type of small molecule drug that is taken orally and works by decreasing the immune system’s production of enzymes that might otherwise exacerbate inflammation. The drug previously gained approval for use in rheumatoid arthritis (RA), severe atopic dermatitis (eczema), and ulcerative colitis 

Upadacitinib now joins tofacitinib (Xeljanz) as the only two JAK inhibitors that are approved for use in ankylosing spondylitis. Tofacitinib gained approval last year 

Treatment guidelines recommend that people with AS start with non-steroidal anti-inflammatory drugs (NSAIDs) before progressing to a biologic in the tumor necrosis (TNF) inhibitor class if necessary. Patients are generally advised to only consider other biologics and small molecule drugs like JAK inhibitors if they have failed a TNF inhibitor.

Upadacitinib is specifically approved for adults with active AS who have failed (or can’t take) at least one TNF blocker. 

Upadacitinib’s approval was guided by the results of two clinical trials, called SELECT-AXIS 1 and SELECT-AXIS 2. Both of these studies pitted upadacitinib against a placebo and found that about half of AS patients who were randomly assigned to get upadacitinib had a clinically-significant response (ASAS40, which indicates an improvement of at least 40 percent over baseline), compared to less than a quarter of those who got a placebo.

JAK inhibitors work well for some patients; studies on RA suggest that they sometimes even outperform biologics.  

But these drugs are not without their downsides: Last year, the FDA updated the boxed warning (the strongest kind) on all JAK inhibitors on the market. These drugs now carry a cautionary notice that they’ve been linked to higher rates of heart attacks and strokes, blood clots, and certain types of cancers. 

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JJ Anderson, et al. Assessment in Ankylosing Spondylitis response criteria. March 2022. 

Rao M. ACR 2020 Debate: JAK Inhibitors vs Biologics After Methotrexate Failure in RA.  

RINVOQ® (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis. Ciscon PR Newsire.

Stewart J. Rinvoq FDA Approval History. 

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