Successful COAST-X Phase III study of Taltz for the treatment of non-radiographic axial spondyloarthritis

Eli Lilly and Company announced that Taltz (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a Phase III study evaluating the safety and efficacy of Taltz for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve.

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 (ASAS40) response compared to placebo. Taltz also met the major secondary endpoints at week 16 and week 52, including significant improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), significant improvement in Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of patients achieving low disease activity (ASDAS <2.1), significant improvement in sacroiliac joint inflammation (SIJ) as assessed by MRI (week 16) and significant improvement in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score. In COAST-X, the safety profile of Taltz was consistent with previously reported Phase III studies of Taltz. No new safety signals were detected.