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▎WuXi AppTec Content Team Editor A few days ago, AbbVie announced that the U.
S.
FDA approved the expanded indication of its JAK inhibitor Rinvoq (upadacitinib, upadacitinib) for the treatment of active ankylosing spondylitis (ankylosing spondylitis, AS) adult patients
.
These patients were intolerant to, or did not have an adequate response to, one or more tumor necrosis factor (TNF) blockers
.
This is the fifth indication for Rinvoq in chronic immune-related diseases, the press release noted
.
FDA approval was supported by the Phase 3 clinical trial SELECT-AXIS 2 (Study 1) and the Phase 2/3 clinical trial SELECT-AXIS 1
.
In both clinical trials, more patients treated with Rinvoq at a dose of 15 mg met the International Spondyloarthritis Society 40 Response Criteria (ASAS40, meaning at least a 40% improvement in disease symptoms)
.
In SELECT-AXIS 1 and SELECT-AXIS 2, the proportion of patients achieving ASAS40 was 51% and 44.
5%, respectively, compared with 26% and 18.
2% in the placebo group, respectively
.
In SELECT-AXIS 2, clinical remission was observed as early as the fourth week after dosing
.
AS is a chronic inflammatory musculoskeletal disease that primarily affects the spine and is characterized by inflammatory back pain, stiffness, and limited mobility
.
Discovered and developed by AbbVie scientists, upatinib is a once-daily oral, selective and reversible JAK inhibitor
.
It has been approved by the US FDA for the treatment of inflammatory diseases such as rheumatoid arthritis, atopic dermatitis, ulcerative colitis,
etc.
"Ankylosing spondylitis is a disabling disease that frequently affects young adults and can cause lasting structural damage over time, placing a heavy mental burden on patients' lives
.
" Chief Scientific Officer, AbbVie "This latest approval is an important step forward in our commitment to advancing the standard of care for rheumatoid disease," said Dr.
Thomas Hudson
.
Reference: [1] RINVOQ® (upadacitinib) Approved by US FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis.
Retrieved April 29, 2022, from https:// adults-with-active-ankylosing-spondylitis-301536539.
htmlDisclaimer: The WuXi AppTec content team focuses on global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.