FDA OKs Ixekizumab (Taltz) for Active Ankylosing Spondylitis

Megan Brooks

Disclosures

August 26, 2019

The US Food and Drug Administration (FDA) has approved the interleukin-17A inhibitor ixekizumab (Taltz, Eli Lilly) for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis, the company has announced.

This is the third indication for ixekizumab. The drug was first approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It was subsequently approved for the treatment of adults with active psoriatic arthritis.

Roughly 1.6 million people in the United States have AS, which affects the pelvic joints and spine and can cause chronic inflammatory back pain, stiffness, and impaired function and mobility, the company noted in a news release.

The efficacy of ixekizumab in AS was demonstrated in two randomized, double-blind, placebo-controlled phase 3 studies that included 657 adult patients with active AS.

The COAST-V trial involved patients who had never used a biologic disease-modifying antirheumatic drug (bDMARD). The COAST-W trial involved patients who previously had an inadequate response to or were intolerant of tumor necrosis factor (TNF) inhibitors.

In both studies, patients who underwent treatment with ixekizumab achieved "statistically significant and clinically meaningful" improvements in signs and symptoms of AS at 16 weeks, as defined by Assessment of Spondyloarthritis International Society 40 (ASAS40) response, compared to patients who received placebo, the company said.

In COAST-V, 48% of patients treated with ixekizumab every 4 weeks achieved ASAS40, compared with 18% of patients treated with placebo (P < .0001); corresponding ASAS40 response rates in COAST-W were 25% with ixekizumab vs 13% with placebo (P < .05).

In both studies, patients who were treated with ixekizumab also showed statistically significant improvements in key secondary endpoints. The proportion of patients who achieved ASAS20 at 16 weeks was higher than that of patients who received placebo (COAST-V: 64% vs 40%; P = .0015; COAST-W: 48% vs 30%; P < .01)

Results from the phase 3 clinical trial program in AS show that ixekizumab "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 the University of Washington, Seattle, said in the news release. "This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS."

Ixekizumab is given by injection, either by itself or in combination with a conventional bDMARD, corticosteroids, nonsteroidal anti-inflammatory drugs, and/or analgesics.

Overall, the safety profile observed in patients with AS who were treated with ixekizumab is consistent with the safety profile seen in patients with psoriasis. Full prescribing information and a medication guide are available online.

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