Taltz® (ixekizumab) Now FDA Approved for Ankylosing Spondylitis

By Spondylitis Association of America

Monday, August 26, 2019

The FDA announced on August 26th that ixekizumab (Taltz) is now approved to treat adults with ankylosing spondylitis (AS), also referred to as radiographic axial spondyloarthritis (r-axSpA.) This extends the IL-17 inhibiting biologic medication’s approval to a second form of spondyloarthritis. (Taltz has been approved since 2017 for psoriatic arthritis.)

“Having new treatment options for the ankylosing spondylitis community is truly encouraging,” commented SAA’s chief executive officer, Cassie Shafer, in the press release. “The ongoing focus to help people impacted by the disease will hopefully lead us to an eventual cure.”

The FDA expanded its approval to include ankylosing spondylitis based on the results of two 16-week long, double-blind, placebo-controlled clinical trials, COAST-V and COAST-W; both studies demonstrated statistically significant and clinically meaningful improvements (as measured by ASAS 40) in pain, inflammation, and function in adults with active AS, as compared with placebo (a mock medication with no therapeutic effects.)

COAST-V achieved this by comparing symptomatic improvements in those taking Taltz versus those taking a placebo, in patients with no previous biologic medication treatments. COAST-W was performed on individuals who had previously taken TNF inhibitors, but did not experience noticeable symptomatic improvements, or who did not tolerate them.

The COAST-V study reported that at 16 weeks, 48% of Taltz-treated patients achieved meaningful improvement (ASAS 40 response1) vs. 18% of those in the placebo group. The COAST-W study reported that at 16 weeks, 25% of Taltz-treated patients achieved meaningful improvement vs. 13% of those in the placebo group.

About Taltz®

Taltz (ixekizumab) is a live biological antibody (derived from living organisms), manufactured by Eli Lilly and Company that works by binding to the IL-17A cytokine that is partially responsible for inflammatory and immune bodily responses. This binding obstructs the cytokine’s interaction with its IL-17 receptor, reducing inflammatory and immune reactions. Thus, patients taking Taltz can hope to experience pain relief and overall general symptom alleviation. However, due to this lowered rate of immune response, patients taking Taltz should also be aware that they may be more susceptible to infections during use.

 

  1. The ASAS Response Criteria (ASAS40) 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). https://eprovide.mapi-trust.org/instruments/assessment-in-ankylosing-spondylitis-response-criteria 

 

Sources Used and Further Reading

https://www.prnewswire.com/news-releases/lilly-receives-us-fda-approval-for-taltz-ixekizumab-for-the-treatment-of-active-ankylosing-spondylitis-radiographic-axial-spondyloarthritis-300906652.html

https://www.ncbi.nlm.nih.gov/pubmed/3036096

https://www.ncbi.nlm.nih.gov/pubmed/30343531

https://www.healio.com/rheumatology/spondyloarthropathies/news/online/%7Bbe94934a-560d-4d28-b372-69653693f335%7D/fda-expands-taltz-approval-for-ankylosing-spondylitis

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