Positive top-line results for second phase 3 study of Taltz in Ankylosing Spondylitis for TNF inhibitor-experienced patients

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Taltz Eli Lilly and CompanyThe results of the COAST-W trial demonstrate that Taltz (ixekizumab; Eli Lilly and Company) is a safe and effective treatment for Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis. COAST-W is a Phase 3 trial, and is the first AS study focusing on a difficult to treat population of patients who had an inadequate response to one or two tumour necrosis factor (TNF) inhibitors (90% of enrolled patients) or intolerance to a TNF inhibitor (10%).

Taltz met the primary and major secondary endpoints in COAST-W, and demonstrated a statistically significant improvement in the signs and symptoms of AS, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks, when compared to placebo. COAST-W is part of the clinical development program for Taltz in AS, the first to use ASAS40 across the program as the primary endpoint to define treatment success, rather than the traditionally used endpoint of ASAS20.

AS is one type of spondyloarthritis that affects the pelvic joints and spine, and can be characterised by chronic inflammatory back pain, stiffness and impaired function and mobility. Of those affected by AS, approximately 80% will experience symptoms before age 30.

“These positive results, in combination with previous results from the Phase 3 COAST-V study, provide further support for Taltz as a potential treatment option for patients with AS, including those who have had an inadequate response to treatment with TNF inhibitors, a difficult-to-treat population,” says Lotus Mallbris, vice president Immunology Development, Eli Lilly and Company. “By using ASAS40 as the primary endpoint in our clinical development program, we hope to establish a higher treatment target goal for AS patients. We look forward to sharing additional clinically meaningful data from this study, and remain committed to continuing our research to evaluate potential treatment options that deliver better outcomes for patients living with this disease.”

In COAST-W, the incidence of serious adverse events was similar with Taltz compared with placebo. The most common adverse events observed were consistent with other Phase 3 studies of ixekizumab.

Lilly plans to submit detailed data from COAST-W for disclosure at scientific meetings and in peer-reviewed journals later this year. Based on the positive results from the COAST-V and COAST-W studies, the company plans to submit for US regulatory approval in AS later this year.

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