Eli Lilly and Company announced Taltz® (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a Phase 3 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 3 studies of Taltz. No new safety signals were detected.
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"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," said Atul Deodhar, M.D., professor of medicine, Oregon Health & Science University and clinical investigator for the COAST program. "The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population."
Axial spondyloarthritis (axSpA) 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. The COAST-X study is part of a clinical development program that aims to evaluate the efficacy and safety of Taltz across various population subsets of patients with axSpA. Results from COAST-V and COAST-W, which evaluated Taltz in AS, were reported in 2018.
"We're encouraged by the results of the COAST-X trial, which support our belief that Taltz could become the first IL-17A antagonist to be approved in the U.S. for people with non-radiographic axSpA," said Christi Shaw, president, Lilly Bio-Medicines. "The COAST-X data add to the growing body of evidence from our COAST program, which demonstrates that Taltz may work across the axSpA disease spectrum."
Lilly plans to submit detailed data from COAST-X for disclosure at scientific meetings and in peer-reviewed journals later this year. Based on these positive data, Lilly plans to submit to regulatory authorities in 2019 for approval for nr-axSpA.
Lilly's application for radiographic axSpA is currently under review with the U.S. Food and Drug Administration (FDA) and regulatory action is expected later this year.