Eli Lilly announces Taltz meets primary, secondary endpoints in COAST-X study

Eli Lilly announced that Taltz met the primary and all major secondary endpoints in COAST-X, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of non-radiographic axial spondyloarthritis, or nr-axSpA, in patients who are biologic disease-modifying anti-rheumatic drug, or bDMARD-naive. These results provide clinical evidence to support a potential role for Taltz in the treatment of nr-axSpA patients. Taltz met the primary endpoint at both week 16 and week 52, demonstrating a statistically significant improvement in the signs and symptoms of nr-axSpA, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40, or ASAS40, response compared to placebo. Taltz also met the major secondary endpoints at week 16 and week 52, including improvement in Ankylosing Spondylitis Disease Activity Score, or ASDAS, significant improvement in Bath Ankylosing Spondylitis Disease Activity, or BASDAI, proportion of patients achieving low disease activity, improvement in sacroiliac joint inflammation as assessed by MRI and improvement in 36-Item Short Form Health Survey, or SF-36, physical component summary score. In COAST-X, the safety profile of Taltz was consistent with previously reported Phase 3 studies of Taltz. No new safety signals were detected. Lilly plans to submit detailed data from COAST-X for disclosure at scientific meetings and in peer-reviewed journals later this year. Based on these positive data, Lilly plans to submit to regulatory authorities for approval for nr-axSpA.

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