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FDA Approves Oral Upadacitinib for Ankylosing Spondylitis

The FDA has approved once-daily oral Upadacitinib (sold under the brand name Rinvoq) for the treatment of adults with active ankylosing spondylitis who are intolerant, or have had an inadequate response, to one or more TNF inhibitors.

”AS” as it’s called is an inflammatory arthritis affecting the spine and large joints, and the condition is more common among men and usually begins in early adulthood.

Symptoms typically appear in early adulthood and include reduced flexibility in the spine. This reduced flexibility eventually results in a hunched-forward posture. Pain in the back and joints is also common. Treatment includes medication, physical therapy, and in rare cases surgery.

FDA approval follows two trials, which found that the medication demonstrated rapid and meaningful disease control among adults with AS, with almost half achieving ASAS40* at week #14, compared with placebo, according to the company. One of the studies, the phase 3 SELECT-AXIS 2 clinical trial, evaluated Upadacitinib in patients who had an inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs (DMARDs). Meanwhile, the phase 2/3 SELECT-AXIS 1 clinical trial examined those who were naïve to biologic DMARDs and had an inadequate response or intolerance to at least two NSAIDs.

In both trials, a significantly larger proportion of patients receiving Upadacitinib 15 mg achieved an ASAS40 response — 51% in SELECT-AXIS 1 and 44.5% in SELECT-AXIS 2 — compared with those receiving placebo — 26% and 18.2%, respectively — at week 14.

Additional data from the trials found that Upadacitinib 15 mg resulted in improvements in AS signs and symptoms, including total back pain, as well as physical function — as measured by the Bath Ankylosing Spondylitis Functional Index — and disease activity — via Patient Global Assessment of Disease Activity score — compared with placebo at week 14.

The observed safety profile of Upadacitinib 15 mg in patients with AS was consistent with those seen in patients with rheumatoid arthritis and psoriatic arthritis, according to the study.

* Developed in 2001, the ASAS Response Criteria (ASAS 20) is defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function (BASFI), and Inflammation.