EC approves RINVOQ (upadacitinib) to treat active psoriatic arthritis

AbbVie has announced that the European Commission (EC) has approved RINVOQ (upadacitinib, 15mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA). The treatment will be used in adult patients who have responded inadequately to or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

According to the company, RINVOQ may be used as monotherapy or in combination with methotrexate. The drug is also indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The EC approval is supported by data from the three pivotal clinical trials SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1, demonstrating RINVOQ’s efficacy across multiple measures of disease activity.

“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 of 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.”

In both Phase III clinical trials, SELECT-PsA 1 and SELECT-PsA 2, RINVOQ met the primary endpoint at week 12 versus placebo in adults with active PsA who had an inadequate response to non-biologic DMARDs or biologic DMARDs, respectively. RINVOQ also achieved non-inferiority to adalimumab (40mg, every other week). Patients receiving RINVOQ experienced greater improvements in physical function and skin symptoms and a greater proportion achieved minimal disease activity (MDA) compared to those receiving placebo at week 24.

The marketing authorisation means that RINVOQ is approved in all member states of the EU, as well as Iceland, Liechtenstein and Norway. RINVOQ is already approved for the treatment of adults with moderate to severe active rheumatoid arthritis.