Eli Lilly and Company announced Taltz (ixekizumab) met the primary and major secondary endpoints in COAST-W, a Phase 3 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.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
AS is one type of spondyloarthritis that affects the pelvic joints and spine, and can be characterized by chronic inflammatory back pain, stiffness and impaired function and mobility. Of those affected by AS, approximately 80 percent 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," said Dr. Lotus Mallbris, vice president, Immunology Development. "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 U.S. regulatory approval in AS later this year.