AbbVie has presented positive data from its phase 2 and 3 SELECT-AXIS 1 trial for Rinvoq, an ankylosing spondylitis (AS) treatment, at the 2019 American College of Rheumatology (ACR)/Association for Rheumatology Professionals (ARP) Annual Meeting in Atlanta, Ga.
|AbbVie's ankylosing spondylitis treatment Rinvoq|
SELECT-AXIS 1 is the first trial to evaluate the efficacy and safety of the treatment in adult patients with active AS, who are naive to biologic disease-modifying antirheumatic drugs (bDMARDs) and have inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).
The trial results showed that twice as many adult patients with active AS treated with Rinvoq achieved the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 14 versus placebo (52 percent vs. 26 percent).
The safety profile of the drug was consistent with that of previous studies in rheumatoid arthritis, with no new safety risks detected, AbbVie said. Through week 14, the proportions of patients with adverse events leading to discontinuation, serious adverse events, and infections were 2 percent, 1 percent and 20 percent for Rinvoq and 3 percent, 1 percent, and 28 percent for placebo, respectively.
No severe infections, herpes zoster, malignancy, adjudicated major adverse cardiovascular events, venous thromboembolic events, or deaths were reported.
The company said it is researching Rinvoq, a JAK (Janus kinase) inhibitor discovered and developed by AbbVie, as a once-daily therapy in AS and multiple immune-mediated inflammatory diseases.
"AS is a chronic, progressive, inflammatory disease that causes pain and stiffness, primarily in the spine, starting in early adulthood," said Professor Desiree van der Heijde at Leiden University Medical Center in the Netherlands. "Apart from biologics, there are limited options available for patients who have an inadequate response or contraindication to NSAIDs."
The results of this study highlight the potential of Rinvoq as an additional treatment option for patients living with AS, he added.
Marek Honczarenko, AbbVie's vice president of immunology development, also said, "Results from the SELECT-AXIS 1 study show that Rinvoq was able to provide significant improvements to signs and symptoms for AS patients."
These data highlight AbbVie's commitment to discovering and developing additional therapies for people living with rheumatic diseases, Honczarenko added.