The Food and Drug Administration (FDA) has approved Taltz (ixekizumab; Eli Lilly) for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).

The approval was based on data from 2 randomized, double-blind, placebo-controlled phase 3 studies, COAST-V and COAST-W, that evaluated the efficacy and safety of ixekizumab for active AS in patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve and tumor necrosis factor (TNF) inhibitor-experienced, respectively (N=657). The primary end point for both studies was the proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16. 

Results from both studies demonstrated Taltz to have statistically significant and clinically meaningful improvements in the ASAS40 response compared to placebo. In the COAST-V study, 48% of patients treated with ixekizumab achieved an ASAS40 response vs 18% for placebo (P <.0001); the COAST-W study also showed 25% of ixekizumab-treated patients achieved an ASAS40 response vs 13% for placebo (P <.05).

Moreover, ixekizumab showed statistically significant improvements in key secondary end points, including an ASAS20 response observed in 64% of ixekizumab-treated patients in the COAST-V study vs 40% for placebo (P =.0015); and an ASAS20 response observed in 48% of Taltz-treated patients in the COAST-W study vs 30% for placebo (P <.01).

The safety profile was consistent with the safety profile seen in patients with psoriasis.

“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,” said Philip Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington.

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Ixekizumab, a humanized interleukin-17A antagonist, is currently approved to treat adults with active psoriatic arthritis and adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is supplied as 80mg single-dose autoinjectors in 1-, 2-, and 3-count cartons or prefilled syringes in 1-count cartons.

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