FDA approves AbbVie's Rinvoq for active ankylosing spondylitis

AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine.

The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis.

The ankylosing spondylitis indication is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

AbbVie provided data from two pivotal studies showing the drug supported The Assessment in SpondyloArthritis international Society 40% (ASAS40) benchmark to win the latest indication.

Rinvoq image courtesy of AbbVie

ASAS40 refers to an at least 40% improvement in three out of four domains related to back pain, disease activity, physical function and inflammation. The ASAS40 response also precludes worsening in a single domain.

In the SELECT-AXIS 2 pivotal trial, 51% of Rinvoq recipients achieved ASAS40, while 44.5% did in the SELECT-AXIS 1 study at 14 weeks. For placebo recipients, 26% achieved the same response in the first trial, while 18.2% did in the second study.

“Ankylosing spondylitis is a debilitating disease that often affects younger adults and, over time, can result in lasting structural damage that can take an emotional toll on a patient’s life,” said Dr. Thomas Hudson, senior vice president, research and development, chief scientific officer at AbbVie, in a statement. “This latest approval demonstrates another important step forward in our mission to advance the standards of care in rheumatic diseases.”

Approximately 0.2% to 0.5% of people in the U.S. have ankylosing spondylitis, according to the Johns Hopkins Arthritis Center.

Treatment can involve physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs) and TNF inhibitors.

In a recent analysis published in JAMA, 33.7% of ankylosing spondylitis patients had a significant response from TNF inhibitors, while 34.3% had no response.

AbbVie announced in October 2021 that Rinvoq met its primary endpoint in the SELECT-AXIS 2 ankylosing spondylitis trial.