June 2020
Up until now there was only one biologic medication FDA approved for use in non-radiographic axial spondyloarthritis: the TNF inhibitor certolizumab pegol (CIMZIA®), which was approved in March of 2019.
In June of 2020, the FDA approved two additional biologic medications – Ixekizumab (Taltz®) and Secukinumab (Cosentyx®), for treatment of active non-radiographic axial spondyloarthritis.
Ixekizumab (Taltz®) was approved on June 1, 2020, with the FDA basing its decision on results from the COAST-X study, which demonstrated safety and efficacy of the 80 mg/mL dose in reducing signs, symptoms, and inflammation in those with non-radiographic axial spondyloarthritis (nr-axSpA). According to Atul Deodhar, MD, MRCP of the Oregon Health and Science University, clinical investigator of the study, and SAA Medical and Scientific Board Member, “Taltz provided relief to nr-axSpA patients living with debilitating symptoms such as chronic back pain and fatigue.” Overall the results were promising, as over a third of those taking the study medication every two weeks, , reported meaningful improvements (reaching ASAS 40[1] criteria of 40% or greater improvement in signs and symptoms). At week 16, 40% of the patients treated with 80mg of ixekizumab every 2 weeks showed improvement, compared to 19% of the placebo group. At week 52, 31% of the treatment group showed meaningful improvement compared to 13% in the placebo group. Ixekizumab (Taltz®) is also approved for the treatment of active ankylosing spondylitis (AS), active psoriatic arthritis (PsA), and moderate to severe plaque psoriasis (PsO).
Secukinumab (Cosentyx®) was approved on June 16, 2020 for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA.) The FDA approval of secukinumab was based on the efficacy and safety outcomes of the Phase III PREVENT trial. Secukinumab achieved statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured by at least a 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40[1]) criteria at both week 16 and week 52 of the trial. At week 16, 41.5% of the participants in the treatment group (receiving 150-mg secukinumab weekly for 4 weeks followed by maintenance with 150 mg monthly) indicated improvement, compared to the placebo group of 29.2% of the participants. At week 52, 35.4% of the treatment group showed improvement vs 19.9% of the placebo group. Secukinumab is also approved for active ankylosing spondylitis, active psoriatic arthritis, and moderate to severe plaque psoriasis (PsO).
In a press release, Cassie Shafer, CEO of the Spondylitis Association of America stated, “There are limited treatment options that can address both AS and nr-axSpA symptoms, and people living with these conditions are often underdiagnosed and undertreated. [These approvals] represent an important milestone in providing relief to patients where there has been a significant unmet need.”
The Spondylitis Association of America is excited about these recent developments and is continuing our ongoing research survey to better understand the roadblocks faced by people in getting diagnosed with non-radiographic axial spondyloarthritis (nr-axSpA.) If you have been diagnosed with non-radiographic axial spondyloarthritis (nr-axSpA), we’d love for you to participate! Learn more and take part here!
***Dr. Atul Deodhar, member of SAA’s Medical and Scientific Board, is an author on both studies.
[1] The ASAS Response Criteria (ASAS 40) is defined as an improvement of at least 40% 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 (last 2 questions of BASDAI).
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