The approval of a new drug is welcome news for our patient community.
Spinal image of a patient with ankylosing spondylitis. Details: Shutterstock.
“The ankylosing spondylitis it is a debilitating disease that often strikes younger adults and over time can cause lasting structural damage that can have an emotional effect on a patient’s life,” said Thomas Hudson, senior vice president, research and development, AbbVie’s chief scientific officer.
“This latest approval demonstrates another important step forward in our mission to advance standards of care for rheumatic diseases,” he said in the statement.
The approval of the FDA in AD is supported by safety and efficacy data from the phase 3 clinical study, SELECT-AXIS 2 (Study 1) that evaluated RINVOQ in patients who had had an inadequate response or intolerance to one or two disease-modifying antirheumatic drugs ( MAME) and the phase 2/3 clinical study, SELECT-AXIS 1, which evaluated RINVOQ in patients who had never received a biologic MAME and had had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs (NSAIDs)1 -3.
“Many patients with ankylosing spondylitis do not achieve disease control with current biologic therapies, and additional treatments are needed to help alleviate the signs and symptoms of this disease,” said Atul Deodhar, professor of medicine and medical director of Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, and investigator of the SELECT-AXIS 1 study.
“With the approval of the FDA Today, patients who do not respond to a TNF inhibitor have an additional oral treatment option in conjunction with their rheumatologist to help take control of this disease,” the news release reveals.
In both the SELECT-AXIS 1 and SELECT-AXIS 2 clinical studies, a significantly higher proportion of patients receiving RINVOQ 15 mg achieved an ASAS40* response, the primary endpoint, (51% and 44.5%, respectively) compared to placebo (26% and 18.2%, respectively) at week 14. Clinical responses were observed as early as week 4 in the SELECT-AXIS study for ASAS401-3 values.
“Currently, treatment options are limited for people living with ankylosing spondylitisparticularly when pain symptoms persist despite the use of TNF blocker therapy,” said Cassie Shafer, chief executive officer, Spondylitis Association of America (SAA).
“The approval of a new drug is welcome news for our patient community, offering them the potential to help more people find meaningful relief from AD symptoms and help them reach their treatment goals,” said Shafer.