FDA Approves Ixekizumab for Ankylosing Spondylitis Indication

Officials with the FDA have approved Eli Lilly’s ixekizumab (Taltz) injection 80 mg/mL for the treatment of active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis, according to a press release.

Ixekizumab was initially approved by the FDA in March 2016 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In 2017, ixekizumab was approved for an active psoriatic arthritis indication.

AS affects the pelvic joints and spine and is often characterized by chronic inflammatory back pain, stiffness, and impaired function and mobility, according to Lilly. The disease is estimated to occur in approximately 1.6 million individuals in the United States.

The newly-approved indication is based on efficacy and safety data from 2 randomized phase 3 studies, which included 657 adult patients with active AS. The COAST-V study evaluated ixekizumab in patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve and the COAST-W study evaluated those who previously had an inadequate response or were intolerant to tumor necrosis factor (TNF) inhibitors.

Data from both studies demonstrated that patients treated with ixekizumab achieved statistically significant and clinically meaningful improvements in signs and symptoms, as defined by Assessment of Spondyloarthritis International Society 40 (ASAS40) response, compared with placebo. Additionally, the safety profile of ixekizumab in patients with AS was similar to the safety profile observed in patients with psoriasis.

At 16 weeks, patients achieved ASAS40 at the following response rates:

  • COAST-V: 48% of patients treated with ixekizumab every 4 weeks versus 18% of patients treated with placebo (p<0.0001).
  • COAST-W: 25% of patients treated with ixekizumab every 4 weeks versus 13% of patients treated with placebo (p<0.05).

The drug also demonstrated statistically significant improvements in the proportion of patients achieving ASAS20 at the following response rates:

  • COAST-V: 64% of patients treated with ixekizumab every 4 weeks versus 40% of patients treated with placebo (p=0.0015).
  • COAST-W: 48% of patients treated with ixekizumab every 4 weeks versus 30% of patients treated with placebo (p<0.01).

Ixekizumab can be used alone or in combination with a conventional DMARD, corticosteroids, non-steroidal anti-inflammatory drugs and/or analgesics.

“Results from the phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors,” Philip Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington, said in a statement. “This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS.”


Lilly Receives US FDA Approval for Taltz (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis). Eli Lilly. http://lilly.mediaroom.com/index.php?s=9042&item=137944. Accessed August 27, 2019.

August 26, 2019


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