5/4/2022
Updated: 7/6/2022
Upadacitinib (Rinvoq), a JAK inhibitor medication taken orally, has gained FDA approval for the treatment of ankylosing spondylitis (AS) in adults.1 Upadacitinib was also approved for psoriatic arthritis (PsA) in December of 2021.
As detailed in a recent Spondylitis Plus article, JAK inhibitors are the latest class of synthetic (non-biologic) drugs, taken orally, that have been proven effective in clinical trials for treating multiple forms of arthritis, including AS and PsA.2
Upadacitinib is approved for the treatment of adults with active AS who have had an inadequate response or intolerance to one or more TNF inhibitors. It is the second JAK inhibitor to gain FDA approval for AS after tofacitinib (Xeljanz or Xeljanz XR), which was approved for AS in December of 2021.
The FDA’s new approval was based on two clinical trials. In both the SELECT-AXIS 1 and SELECT-AXIS 2 trials, adults with AS were given either 15mg upadacitinib or a placebo (inactive pill). A significantly larger proportion of adults (51% and 44.5%, in each respective study) achieved an ASAS40 response – at least a 40% improvement in disease activity – compared to those who received a placebo (26% and 18.2%, respectively) at week 14.3, 4 ASAS40 responses were observed as early as week four.
“Many patients with ankylosing spondylitis do not achieve disease control with current biologic therapies, and additional treatments are needed to help relieve the signs and symptoms of this disease,” said rheumatologist Atul Deodhar, MD, professor of medicine and a member of SAA’s Medical and Scientific Advisory Board, and investigator of the SELECT-AXIS 1 trial. “With [this] FDA approval, patients who do not respond to a TNF inhibitor have an additional oral treatment option, in partnership with their rheumatologist, to help take control of this disease.”1
In September of 2021, the FDA issued a new drug safety report for JAK inhibitors, after a review of a large, randomized safety trial of the JAK inhibitor tofacitinib that included RA patients aged 50 and older who had one or more preexisting cardiovascular risk factors. Based on data from that trial, the FDA has required new label updates for the JAK inhibitors upadacitinib, tofacitinib, and baricitinib, warning of increased risks of heart attack, stroke, certain cancers, and other serious side-effects.
Those who are prescribed a JAK inhibitor should speak to their doctor about these potential risks.
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