AbbVie’s JAK Inhibitor Rinvoq Meets Primary Endpoints in Two Phase 3 Trials for Axial Spondyloarthritis

On October 7, 2021, AbbVie announced that two Phase 3 clinical trials of its oral JAK inhibitor upadacitinib (brand name Rinvoq) in adult patients with axial spondyloarthritis (axSpA) both met their primary endpoints.

Results from two Phase 3 clinical trials demonstrated that at Week 14, in both patients with non-radiographic axial spondyloarthritis (nr-axSpA) and patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic therapies, a greater proportion of patients in the upadacitinib group achieved an Assessment of SpondyloArthritis international Society (ASAS) 40 response compared with placebo. Patients experienced statistically significant improvements in symptoms, including back pain and inflammation, as well as improvements in physical function and disease activity. Axial spondyloarthritis is a chronic inflammatory disease that affects the spine and can cause back pain, restricted mobility, and structural damage.

In patients with active ankylosing spondylitis (AS)

In the upadacitinib group, 45% of patients achieved an ASAS40 response, significantly higher than in the placebo group (18%).

In addition, upadacitinib also met multiple secondary endpoints of the trial, with specific results shown in the figure below.

The safety data are consistent with previous studies, and no new risks have been identified.

Image source: Reference [1]

In patients with active non-radiographic axial spondyloarthritis

In the upadacitinib group, 45% of patients met the ASAS40 criteria, significantly higher than that in the placebo group (23%).

In addition, upadacitinib also met multiple secondary endpoints of the trial. Detailed results are shown in the figure below.

Image source: Reference [2]

Upadacitinib was discovered and developed by AbbVie scientists and is a selective, reversible JAK inhibitor administered orally once daily. In August 2019, it received U.S. FDA approval for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The JAK protein family mediates the signaling of multiple inflammatory cytokines. Upadacitinib has demonstrated positive results in Phase 3 clinical trials for the treatment of various inflammatory diseases, including rheumatoid arthritis, atopic dermatitis, Crohn's disease, and psoriatic arthritis.

References:

[1] AbbVie's RINVOQ® (upadacitinib) Met Primary and All Ranked Secondary Endpoints in Phase 3 Study in Ankylosing Spondylitis. Retrieved October 7, 2021, from https://www.prnewswire.com/news-releases/abbvies-rinvoq-upadacitinib-met-primary-and-all-ranked-secondary-endpoints-in-phase-3-study-in-ankylosing-spondylitis-301395108.html

[2] AbbVie's upadacitinib (RINVOQ®) Met Primary and Most Ranked Secondary Endpoints in Phase 3 Study for Non-Radiographic Axial Spondyloarthritis. Retrieved October 7, 2021, from https://www.prnewswire.com/news-releases/abbvies-upadacitinib-rinvoq-met-primary-and-most-ranked-secondary-endpoints-in-phase-3-study-for-non-radiographic-axial-spondyloarthritis-301395109.html

(Original text abridged)

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