EU approves Rinvoq in non-radiographic axial spondyloarthritis.- AbbVie
AbbVie announced that the European Commission (EC) has approved Rinvoq (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
AbbVie previously disclosed topline results from the Phase III SELECT-AXIS 2 nr-axSpA clinical trial and the full results have been published in The Lancet. Study results show a significantly greater proportion of patients receiving Rinvoq 15 mg achieved an Assessment of SpondyloArthritis international Society 40 percent (ASAS40) response at week 14 (45 percent versus 23 percent; p<0.0001) compared to placebo. statistical significance was also achieved in 12 of the 14 multiplicity-controlled secondary endpoints compared to placebo at week 14. safety data were previously reported with no new risks identified compared to the known safety profile of rinvoq. through week 14, the proportion of patients who experienced an adverse event (ae) was similar between treatment groups (rinvoq at 48 percent and placebo at 46 percent).></0.0001)>
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