Upadacitinib has been now approved for use in adult patients with nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation and who have shown inadequate response to or intolerance to treatment with tumor necrosis factor (TNF) inhibitor/s. With this approval, patients now have a new therapeutic option, which may help them to improve their quality of life.^1,2

Earlier this year, the US FDA had approved upadacitinib for use in adults with active ankylosing spondylitis who failed to respond to TNF blocker/s or exhibited intolerance to the treatment. The new approval makes upadacitinib the only JAK inhibitor that has been FDA-approved for both ankylosing spondylitis and nr-axSpA. Also, this is the sixth approved indication for upadacitinib, which is already approved for use in moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), refractory, moderate to severe atopic dermatitis and moderately to severely active ulcerative colitis.

Upadacitinib has been approved in the dose of 15 mg orally once daily.

Nr-axSpA is a chronic inflammatory arthritis, which is symptomatic but has negative findings on x-ray with no evident signs of joint damage. It is a subtype of axial spondyloarthritis. Some patients with Nr-axSpA may progress to ankylosing spondylitis. The characteristic symptom of Nr-axSpA is back pain.

The FDA approval is based on the positive findings from the phase 3 SELECT-AXIS 2 clinical trial.

Patients being treated with upadacitinib must be closely monitored for infections, including tuberculosis (TB), which may be serious in nature. The risk of mortality and major adverse cardiovascular events may be increased in persons aged ≥50 years with at least one cardiovascular risk factor. The risk for lymphoma and skin cancers is also increased.

References

1. FDA Approves Upadacitinib (Rinvoq) for Sixth Indication - Medscape - Oct 24, 2022.
2. https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-receives-its-sixth-us-fda-approval.htm.