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FDA Approves Taltz for the Treatment of Ankylosing Spondylitis

Web Exclusives - FDA Approvals, News & Updates

On August 26, 2019, the FDA approved a new indication for ixekizumab (Taltz; Eli Lilly) for the treatment of adult patients with active ankylosing spondylitis (AS). Ixekizumab has received previous FDA approval for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as for the treatment of adult patients with active psoriatic arthritis.

This latest approval was based on data from 2 randomized, double-blind, placebo-controlled, phase 3 clinical trials of 657 adult patients with active AS (COAST-V and COAST-W). The COAST-V trial (N = 341) evaluated ixekizumab in patients with AS who had not previously received treatment with biologic disease-modifying antirheumatic drugs, whereas the COAST-W trial (N = 316) evaluated the drug in patients with AS who had previous inadequate response or intolerance to tumor necrosis factor inhibitors. The primary end point of both trials was a 40% Assessment in Spondyloarthritis International Society (ASAS40) response by week 16.

Patients treated with ixekizumab in both studies achieved significant and clinically meaningful improvement in signs and symptoms, as defined by ASAS40 response compared with those treated with placebo.

In COAST-V, 48% of patients receiving ixekizumab achieved ASAS40, compared with 18% of those receiving placebo (P <.0001). In COAST-W, 25% of patients receiving ixekizumab achieved ASAS40 compared with 13% of those receiving placebo (P <.05).

The most common (>1%) adverse reactions observed with the treatment of ixekizumab are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the side effects seen in patients with AS treated with ixekizumab in the COAST-V and COAST-W trials were consistent with those seen in patients with plaque psoriasis treated with the drug.

“Having new treatment options for the ankylosing spondylitis community is truly encouraging,” said Cassie Shafer, Chief Executive Officer, Spondylitis Association of America, in a press release by Eli Lilly. “The ongoing focus to help people impacted by the disease will hopefully lead us to an eventual cure.”

The recommended dose of ixekizumab for the treatment of AS is 160 mg by subcutaneous injection (two 80-mg injections) at week 0, followed by 80 mg every 4 weeks.

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Last modified: October 3, 2019
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