AbbVie announced positive top-line results from a phase 3 trial for the efficacy and safety of upadacitinib for individuals with the rheumatic disease.
AbbVie has announced positive top-line results from a phase 3 clinical trial that evaluated the efficacy and safety of upadacitinib (Rinvoq) for individuals with active ankylosing spondylitis (AS) who had inadequate response to biological disease-modifying anti-rheumatic drug therapy, the company said in a statement.
"AbbVie is committed to improving standards of care for patients with rheumatic diseases. We are encouraged by these results that show RINVOQ was able to provide significant improvements in signs and symptoms, as well as other measures of disease activity, for patients living with ankylosing spondylitis who have already failed treatment with a biologic." Michael Severino, MD, vice chairman and president of AbbVie, said in the statement.
In the first of 2 studies of the SELECT-AXIS 2 phase 3 trial, upadacitinib met its primary endpoints of assessment in SpondyloArthritis International Society (ASAS) 40 response, and all ranked secondary endpoints at week 14.
Upadacitinib-treated individuals achieved ASAS40 response at week 14 at 45% compared with those treated with a placebo, at 18%.
The treatment with upadacitinib resulted in a reduction of signs and symptoms of AS, including back pain and inflammation, while simultaneously improving physical function and disease activity at week 14.
Safety data were consistent with previous studies and known safety profile with no new risks identified.
The results were used to support the European Commission approval of upadacitinib in January 2021.
AbbVie's RINVOQ® (upadacitinib) Met Primary and All Ranked Secondary Endpoints in Phase 3 Study in Ankylosing Spondylitis. AbbVie. News release. October 7, 2021. Accessed on October 11, 2021. https://news.abbvie.com/news/press-releases/abbvies-rinvoq-upadacitinib-met-primary-and-all-ranked-secondary-endpoints-in-phase-3-study-in-ankylosing-spondylitis.htm