NORTH CHICAGO, Ill.—AbbVie Inc. reported today that the European Commission (EC) has approved RINVOQ (upadacitinib, 15 mg) for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). RINVOQ, an oral, selective and reversible JAK inhibitor, may be used as a monotherapy or in combination with methotrexate. RINVOQ is also approved for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. 

“Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of life for those living with these conditions,” said Dr. Tom Hudson, senior vice president, R&D, and chief scientific officer of AbbVie. “We are proud to provide RINVOQ as a new treatment option to patients with PsA and a first-in-class treatment option to those living with AS. These approvals are important milestones in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases.”

The EC approval was supported by data demonstrating RINVOQ’s efficacy across multiple measures of disease activity, from three clinical trials — SELECT-PsA 1, SELECT-PsA 2, and SELECT-AXIS 1.

In two Phase 3 clinical trials — SELECT-PsA 1 and SELECT-PsA 2 — RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo in adults with active PsA who had an inadequate response to DMARDs. RINVOQ also achieved non-inferiority to adalimumab (40mg, every other week) for ACR 20 at week 12. Patients receiving RINVOQ experienced greater improvements in physical function (as measured by HAQ-DI at week 12) and skin symptoms (as measured by PASI-75 at week 16), and a greater proportion achieved minimal disease activity compared to those receiving placebo at week 24.

RINVOQ also met the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 versus placebo in SELECT-AXIS 1, a Phase 2/3 study in adult patients with AS who were naïve to biologic DMARDs, and who had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs. RINVOQ achieved statistical significance across several secondary endpoints, including ASAS partial remission (PR) at week 14 and Bath Ankylosing Spondylitis Disease Activity Index 50 at week 14.

Safety results were consistent with those observed in rheumatoid arthritis, with no new significant safety risks identified. Integrated safety data for SELECT-PsA 1 and SELECT-PsA 2 through week 24 show that serious adverse events (SAEs) occurred in 4.1% of the patients in the RINVOQ 15 mg group, compared to 3.7% in the adalimumab group and 2.7% in the placebo group. The most common adverse events reported were upper respiratory tract infection, nasopharyngitis, increased blood CPK, ALT increase, and AST increase. 

In SELECT-AXIS 1, SAEs were reported in 1% of the patients in both the RINVOQ 15 mg and placebo group. The most common adverse events included blood CPK increase, diarrhea, nasopharyngitis, headache, and nausea.

“Psoriatic arthritis and ankylosing spondylitis are multi-faceted diseases that can cause severe pain, restricted mobility, and lasting structural damage. In clinical trials, RINVOQ demonstrated improvements across multiple manifestations of these diseases. The approvals of RINVOQ for the treatment of PsA and AS offer physicians in the European Union an important new therapeutic option and for their patients a new opportunity to find meaningful relief from their debilitating symptoms,” added Iain McInnes, Professor of Medicine and Versus Arthritis Professor of Rheumatology at University of Glasgow, UK. 

RINVOQ is now approved in all member states of the European Union, as well as in Iceland, Liechtenstein, and Norway. RINVOQ has also been previously approved by the FDA and the EC for the treatment of adults with moderate to severe active rheumatoid arthritis. Additional Phase 3 trials of RINVOQ are ongoing in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis, and Takayasu arteritis.