Ixekizumab (Taltz ) has met the primary and all major secondary endpoints in COAST-X, a phase 3 study evaluating the safety and efficacy of Ixekizumab 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 Ixekizumab in the treatment of nr-axSpA patients.
Ixekizumab 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 ASAS40 ( Assessment of Spondyloarthritis International Society 40 ) response compared to placebo.
Ixekizumab has also met the major secondary endpoints at week 16 and week 52, including significant improvement in ASDAS ( Ankylosing Spondylitis Disease Activity Score ), significant improvement in BASDAI ( Bath Ankylosing Spondylitis Disease Activity ), proportion of patients achieving low disease activity ( ASDAS less than 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 Ixekizumab was consistent with previously reported phase 3 studies of Ixekizumab.
No new safety signals were detected.
Non-radiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients.
Axial spondyloarthritis is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the axial skeleton and is estimated to affect 4.5 million adults worldwide.
AxSpA is recognized as a single disease entity, with a patient subset defined by the presence of radiographically defined structural damage of the sacroiliac joints ( radiographic axSpA or ankylosing spondylitis [ AS ] ) and a patient subset without clear structural damage radiographically ( nr-axSpA ). These two patient subsets share a similar burden of disease and similar clinical features, such as spinal inflammation and chronic inflammatory back pain.
Ixekizumab binds to interleukin 17 ( IL-17 ), a pro-inflammatory cytokine, and blocks its action. The antibody has affinity to the homodimer IL-17A and the heterodimer IL-17A/F. ( Xagena )
Source: Lilly, 2019