Upadacitinib (Rinvoq) has been approved by the European Commission for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA) in adults whose response to NSAIDS is inadequate, according to a July 29 announcement from manufacturer, AbbVie.
Upadacitinib is a selective Janus kinase (JAK) inhibitor that preferentially inhibits signaling by JAK1 or JAK 1/3 in human cellular assays. It is the first JAK inhibitor to be approved for patients across the axial spondyloarthritis spectrum, according to AbbVie.
The approval was based on data from the phase 3 SELECT-AXIS 2 pivotal clinical trial, the full results of which were published in The Lancet.
In the study, adult patients with active nr-axSpA were randomly assigned to receive 15 mg of oral upadacitinib once daily or a placebo. A total of 145 patients in the upadacitinib group and 150 in the placebo group received treatment for the full 14 weeks of the study. The primary outcome was 40% improvement in Assessment of SpondyloArthritis International Society response criteria (ASAS40) at 14 weeks.
Significantly more patients in the upadacitinib group achieved an ASAS40 response, compared with patients who received placebo (45% vs 23%; P < .0001).
Previously reported safety data showed no new risks beyond the known safety profile of upadacitinib. Adverse events were similar between the groups. They occurred in 48% of patients taking upadacitinib and 46% of those taking placebo.
Serious adverse events and events leading to discontinuation of the study occurred in four (3%) patients taking upadacitinib and two (1%) taking placebo. A total of five patients taking upadacitinib developed neutropenia; however, none experienced opportunistic infections, major adverse cardiovascular events, venous thromboembolic events, or deaths during the study period.
“The European Commission’s approval of Rinvoq for the treatment of nr-axSpA offers physicians in the European Union an important new therapeutic option with proven efficacy in both nr-axSpA and AS patient populations,” Filip Van den Bosch, MD, a study investigator and a rheumatologist at the University Hospital of Ghent University, Ghent, Belgium, said in the AbbVie announcement.
Upadacitinib is now approved for nr-axSpA in all member states of the European Union, as well as Iceland, Liechtenstein, Northern Ireland, and Norway, the company said.
Upadacitinib is contraindicated for patients who are hypersensitive to the active substance or to any of the excipients in the upadacitinib pill. It is also contraindicated for patients with active tuberculosis or active serious infections, patients with severe hepatic impairment, and patients who are pregnant.