FDA has approved AbbVie’s Rinvoq (upadacitinib) for adults with active non-radiographic axial spondyloarthritis (nr-axSpA).
The indication covers nr-axSpA patients with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors.
The JAK1 selective inhibitor Rinvoq now has six U.S. indications.
The new indication makes Rinvoq the only JAK inhibitor approved for adults with nr-axSpA.
To win the latest indication, Abbott submitted data from the Phase 3 SELECT-AXIS 2 clinical study focusing on adults with active nr-axSpA. The placebo-controlled study found that almost half of the recipients of Rinvoq 15 mg had achieved at least 40% improvement based on the Assessment in SpondyloArthritis International Society scale (ASAS40) at week 14. ASAS40 was the primary endpoint.
The safety profile of Rinvoq was similar in the nr-axSpA demographic to earlier Rinvoq trials involving patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
FDA first approved Rinvoq for moderate to severe rheumatoid arthritis in 2019. An indication followed for active psoriatic arthritis in 2021.
FDA granted three additional indications to Rinvoq in the first half of 2022 — for atopic dermatitis, ulcerative colitis and active ankylosing spondylitis.
In July, North Chicago, Illinois–based Abbott announced that it is also pursuing a Rinvoq indication for Crohn’s disease.
Nr-axSpA is a chronic inflammatory disease associated with joint inflammation. X-ray cannot detect Nr-axSpA.
The company is also pursuing Rinvoq indications for giant cell arteritis and Takayasu arteritis.
AbbVie hopes Rinvoq’s growing use will help reduce its reliance on Humira, which drove almost 37% of its revenue in 2021.
In 2021, FDA released a safety communication about JAK inhibitors, warning about their potential to cause cardiovascular side effects. The warning focused on Pfizer’s Xeljanz (tofacitinib), which was studied in the ORAL Surveillance study, which was profiled in NEJM. The FDA’s notice acknowledged that it did not have sufficient data to adequately evaluate Rinvoq but noted that the medication “may have similar risks as seen in the Xeljanz safety trial.”
The decision added “black box warnings” to all FDA-approved JAK inhibitors for inflammatory diseases.
Filed Under: Rheumatology
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