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Eli Lilly announced today the results of the COAST-W trial showing that ixekizumab (Taltz) was effective in a Phase 3 study Ankylosing Spondylitis (AS) patients who had an inadequate response or intolerance to tumor necrosis factor (TNFi) inhibitor therapy.
COAST-W is a multicenter, randomized, double-blind, placebo-controlled 16-week study of the efficacy and safety of ixekizumab in active AS patients who were TNFi-IR. Patients were treated with 80 mg of Taltz SC either every two weeks or every four weeks (following a 80 mg or 160 mg starting dose at Week 0), or placebo. The primary efficacy endpoint was the proportion of patients at 16 weeks who achieved ASAS40 response.
The Taltz development program (COAST) in axial SpA (AS) includes the three different trials COAST-V (bDMARD-naïve), COAST-W (TNFi experienced), and COAST-X (non-radiographic axSpA who are bDMARD-naïve) studies . A long-term extension study will study patients for an additional two years.
COAST-W trial showed superior (ASAS40) responses at 16 weeks compared to placebo treated patients. The incidence of serious adverse events was similar with Taltz compared with placebo.
Ixekizumab is currently FDA approved for the treatment of adults with active psoriatic arthritis and adults with moderate-to-severe plaque psoriasis.