European Commission Approves AbbVie Axial Spondyloarthritis Treatment

AbbVie announced that the European Commission approved Rinvoq (upadacitinib) for treatment of active non-radiographic axial spondyloarthritis (axSpA) on July 29, 2022. It is approved for adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or magnetic resonance imaging, who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

AxSpA is a chronic, progressive, and disabling inflammatory rheumatic disease that causes joint inflammation. There are two subsets: radiographic (r-axSpA) and non-radiographic (nr-axSpA); according to an AbbVie press release, approximately 10-40 percent of patients eventually progress from nr-axSpA to r-axSpA over a 2-to-10-year period.

Upadacitinib is a selective janus kinase (JAK) inhibitor that is being evaluated for various immune-mediated inflammatory diseases. In human cellular assays, it preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.

"For years, healthcare providers and patients have had limited treatment options to manage axial spondyloarthritis, which can cause back pain, stiffness, and irreversible damage to the spine," said Thomas Hudson, chief scientific officer and senior vice-president of Research and Development, AbbVie, in the press release. "AbbVie is proud to offer [upadacitinib] as a first-in-class treatment option now approved in the European Union for adults living with nr-axSpA with objective signs of inflammation and inadequate response to NSAIDs. {Upadacitinib] is the first and only JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis, which includes nr-axSpA and ankylosing spondylitis."

Source: AbbVie