The Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 SELECT-AXIS 2 trial (ClinicalTrials.gov Identifier: NCT04169373), which evaluated the efficacy and safety of upadacitinib in 314 adults with active nr-axSpA. Patients were randomly assigned 1:1 to receive either upadacitinib 15mg once daily or placebo.
Results showed that a significantly greater proportion of patients treated with upadacitinib achieved an Assessment in SpondyloArthritis International Society 40 (ASAS40) response at week 14 (primary endpoint) compared with placebo (44.9% vs 22.3%, respectively); these responses were observed as early as 2 weeks in the upadacitinib arm.
Additionally, improvements in individual components of the ASAS40 response criteria (Patient Global Assessment of Disease Activity, total back pain, Bath Ankylosing Spondylitis Functional Index, inflammation, high sensitivity C-reactive protein) were observed in upadacitinib-treated patients vs the placebo arm. Upadacitinib was also associated with significant improvements in health-related quality of life as measured by Ankylosing Spondylitis Quality of Life at week 14 compared with placebo.
The most common adverse events reported were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache.
“This latest FDA approval of Rinvoq in active nr-axSpA provides a new oral, once-daily treatment option for patients who historically have had limited treatment options for this painful, chronic disease,” said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie. “Rinvoq is now approved to treat patients across the spectrum of axial spondyloarthritis.”
Rinvoq is already indicated for the treatment of active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active rheumatoid arthritis (RA), moderate to severe atopic dermatitis, and moderately to severely active ulcerative colitis.
The product is supplied as 15mg, 30mg, and 45mg extended-release tablets.
- Rinvoq® (upadacitinib) receives its sixth US FDA approval. News release. AbbVie. Accessed October 21, 2022. https://www.multivu.com/players/English/9092951-abbvie-fda-active-non-radiographic-axial-spondyloarthritis/
- Rinvoq. Package insert. AbbVie; 2022. Accessed October 21, 2022. https://www.rxabbvie.com/pdf/rinvoq_pi.pdf