COAST-W Phase III study of Taltz meets primary endpoint in Ankylosing Spondylitis.- Eli Lilly.

Eli Lilly announced that Taltz (ixekizumab) met the primary and major secondary endpoints in COAST-W, a Phase III study evaluating the safety and efficacy of Taltz for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the first AS study focusing on a difficult-to-treat population of patients who had an inadequate response to one or two tumor necrosis factor (TNF) inhibitors (90 percent of enrolled patients) or intolerance to a TNF inhibitor (10 percent). Taltz 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. 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 III 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 U.S. regulatory approval in AS later this year.

Comment: The COAST-W study is part of a clinical development program that aims to evaluate the efficacy and safety of ixekizumab across various population subsets of patients with axSpA. The COAST program includes three registration studies, each of one year duration: COAST-V in patients with AS/active radiographic axSpA who are bDMARD-naïve; COAST-W in patients with AS/active radiographic axSpA who previously had an inadequate response or intolerance to TNF inhibitors; and COAST-X in patients with non-radiographic axSpA who are bDMARD-naïve. Patients may enroll into a long-term extension study after completion of any of the registration studies to receive ixekizumab treatment for up to an additional two years.