Based on these positive results, Lilly has submitted for U.S. regulatory approval for adults with active non-radiographic axial spondyloarthritis

TORONTO, Nov. 26, 2019 (GLOBE NEWSWIRE) -- Eli Lilly and Company presented detailed results from the COAST-X study at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting in Atlanta as a plenary presentation. COAST-X is a 52-week placebo-controlled Phase 3 study, evaluating the safety and efficacy of TALTZ for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. The study showed that TALTZ® (ixekizumab) met the primary and all major secondary endpoints.

"Currently, there are limited biological treatments for patients living with non-radiographic axSpA," says Dr. Proton Rahman, Rheumatologist, Eastern Health, St. Johns, Newfoundland. "The results of COAST-X demonstrated that TALTZ improved the signs and symptoms of this debilitating disease, and therefore, could be an important treatment option for this patient population.”  

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the spine skeleton and is estimated to affect 4.5 million adults worldwide.1,2,3 AxSpA is recognized as a single disease entity, with one patient subset defined by the presence of radiographically defined structural damage of the sacroiliac joints (radiographic axSpA or ankylosing spondylitis [AS]) and a second patient subset without clearly detectable structural damage radiographically (nr-axSpA).4 While these two patient subsets share a similar burden of disease and similar clinical features, such as inflammation in the axial skeleton, which result in chronic inflammatory back pain and fatigue, the biologic treatment options for patients with nr-axSpA are much more limited.5,6

“Given the nature of non-radiographic axial spondyloarthritis and the impact it has on a patient’s quality of life, there is a clear need for more treatment options,” says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Lilly Canada. “Lilly is committed to fulfilling this need and we are very pleased that TALTZ has met all primary and major secondary endpoints in the COAST-X study.”

A total of 303 adult patients with active nr-axSpA were randomized to receive TALTZ 80 mg subcutaneously every 4 weeks or every 2 weeks (following 80 mg or 160 mg starting dose at Week 0) or placebo. The proportion of patients achieving the primary endpoint of improvement in the signs and symptoms of nr-axSpA as measured by Assessment of Spondyloarthritis International Society 40 (ASAS40) response was superior for TALTZ compared to placebo with statistically significant difference (P