The European Commission ( EC ) has approved Rinvoq ( Upadacitinib, 15 mg ), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis ( PsA ) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with Methotrexate.
Rinvoq 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.
In both 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 psoriatic arthritis who had an inadequate response to non-biologic disease-modifying antirheumatic drugs ( DMARDs ) or biologic DMARDs, respectively.
Upadacitinib has also achieved non-inferiority to Adalimumab ( 40mg, every other week ) for ACR 20 at week 12.
Patients receiving Upadacitinib have 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 ( MDA ) compared to those receiving placebo at week 24.
Upadacitinib has 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 ankylosing spondylitis who were naïve to biologic DMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs ( NSAIDs ).
Additionally, Upadacitinib has achieved statistical significance across several multiplicity adjusted key secondary endpoints versus placebo, including ASAS partial remission ( PR ) at week 14 and Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) 50 at week 14.
Safety results from SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 have been previously reported and 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 occurred in 4.1% of the patients in the Upadacitinib 15 mg group compared to 3.7% in the Adalimumab group and 2.7% in the placebo group.
The most common adverse events reported with Upadacitinib 15 mg were upper respiratory tract infection, nasopharyngitis, increased blood CPK, ALT increase and AST increase.
In SELECT-AXIS 1, serious adverse events were reported in 1% of the patients in both the Upadacitinib 15 mg and placebo group.
The most common adverse events reported with Upadacitinib 15 mg included blood CPK increase, diarrhea, nasopharyngitis, headache and nausea. ( Xagena )
Source: Abbvie, 2021