- With this approval, RINVOQ® (upadacitinib 15 mg, once daily) is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in the European Union (EU)1
- Approval is supported by data from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered meaningful disease control with nearly half of nr-axSpA patients achieving ASAS40 at week 14 (45 percent versus 23 percent; p<0.0001) compared to placebo2
AbbVie (NYSE: ABBV) today 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).*1
“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, M.D., senior vice president of research and development, chief scientific officer, AbbVie. “AbbVie is proud to offer RINVOQ 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. RINVOQ is the first and only JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis, which includes nr-axSpA and ankylosing spondylitis.”
Axial spondyloarthritis (axSpA) is a chronic, progressive and disabling inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness.3,4,5 AxSpA consists of two subsets that have been clinically defined as ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA), and non-radiographic axial spondyloarthritis (nr-axSpA).6 Approximately 10-40 percent of patients eventually progress from nr-axSpA to r-axSpA over a 2- to 10-year period.7
“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,” said Filip Van den Bosch, M.D.,** SELECT-AXIS 2 investigator and professor in the Department of Rheumatology at the University Hospital of Ghent University. “Living with nr-axSpA can pose many challenges and significantly impact a patient’s quality of life. Early and effective disease management of patients with active nr-axSpA is key to improving health outcomes.”
AbbVie previously disclosed topline results from the Phase 3 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.2 Statistical significance was also achieved in 12 of the 14 multiplicity-controlled secondary endpoints compared to placebo at week 14.2 Safety data were previously reported with no new risks identified compared to the known safety profile of RINVOQ.2 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).2
About Axial Spondyloarthritis (axSpA)
Axial spondyloarthritis is a chronic inflammatory disease that affects the spine, causing back pain, limited mobility, and structural damage.6 It consists of two subsets that have been clinically defined as radiographic axial SpA (ankylosing spondylitis) and non-radiographic axial spondyloarthritis (nr-axSpA).6 In ankylosing spondylitis, patients have definitive structural damage of the sacroiliac joints visible on X-rays. Non-radiographic axial spondyloarthritis is clinically defined by the absence of definitive X-ray evidence of structural damage to the sacroiliac (SI) joint by plain X-ray.6
About RINVOQ® (upadacitinib)1
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.
In the EU, RINVOQ is approved for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; 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; for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated CRP and/or MRI, who have responded inadequately to NSAIDs; for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy; for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis; and for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.