COAST-X phase III trial of Taltz meets primary and secondary endpoints in axial spondyloarthritis.- Eli Lilly

Eli Lilly presented detailed results demonstrating Taltz (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a 52-week placebo-controlled Phase III 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)-na�ve.

At Week 16, 35 percent of patients treated with Taltz every four weeks and 40 percent of patients treated with Taltz every two weeks achieved ASAS40 response, compared to 19 percent of patients treated with placebo. At Week 52, 30 percent of patients treated with Taltz every four weeks and 31 percent of patients treated with Taltz every two weeks achieved ASAS40 response, compared to 13 percent of patients treated with placebo. Taltz also met the major secondary endpoints in the study 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 as assessed by mri week 16 and significant improvement in 36-item short form health survey sf-36 physical component summary pcs score.>

The overall safety profile of Taltz was consistent with previously reported results, with no new or unexpected safety findings.The data are being presented at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting.