Upadacitinib (Rinvoq) has become the first JAK inhibitor medication to gain FDA approval for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in adults.1 Upadacitinib was also approved for ankylosing spondylitis (AS) in April of 2022, and 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 as pills, that have been proven effective in clinical trials for treating multiple forms of arthritis, including AS, PsA, and now nr-axSpA.
Upadacitinib is approved for the treatment of adults with active nr-axSpA who have objective signs of inflammation, and who have had an inadequate response or intolerance to one or more TNF inhibitors.
The FDA’s new approval was based on the SELECT-AXIS 2 clinical trial, which assessed the drug’s efficacy and safety in 314 adults with nr-axSpA. Study participants were given either 15mg upadacitinib or a placebo (inactive pill). A significantly larger proportion of adults (44.9%) achieved an ASAS40 response – at least a 40% improvement in disease activity – compared to those who received a placebo (22.3%) at week 14. ASAS40 responses were observed as early as week two.2
In those who received upadacitinib, improvements were observed in disease activity, pain, functioning, quality of life, and inflammation of the sacroiliac (SI) joints as seen on MRI after 14 weeks of treatment.3
“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease [activity] with current treatments,” said Atul Deodhar, MD, professor of medicine and a member of SAA’s Medical and Scientific Advisory Board, and lead investigator of the SELECT-AXIS 2 nr-axSpA trial. “[This] FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”1
“There are limited treatment options for people living with nr-axSpA, a condition that can pose challenges for patients and significantly impact their quality of life,” added Cassie Shafer, SAA’s CEO. “This approval of Rinvoq is a tremendous step forward in providing our patient community with another option to help them reach their treatment goals, and to find relief.”1
JAK inhibitors including upadacitinib carry an FDA boxed warning listing increased risks of heart attack, stroke, certain cancers, blood clots, and other serious side-effects. The warning is based on data from 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.
Those who are prescribed a JAK inhibitor should speak to their doctor about these potential risks.
- RINVOQ® (Upadacitinib) Receives Its Sixth U.S. FDA Approval | AbbVie News Center
- Upadacitinib Approved for Active Nonradiographic Axial Spondyloarthritis (rheumatologyadvisor.com)
- Efficacy and Safety of Upadacitinib in Patients With Active Non-Radiographic Axial Spondyloarthritis: A Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial | Annals of the Rheumatic Diseases (bmj.com)
Spondylitis Association of America