Eli Lilly has announced top-line results from a phase 3 trial evaluating ixekizumab for the treatment of non-radiographic axial spondyloarthritis (nr-SpA).
The COAST-X trial was conducted in 305 biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients with nr-axSpA. The primary outcome measure of the study was the proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at week 16 and week 52.
Results showed that treatment with ixekizumab led to a statistically significant improvement in the signs and symptoms of nr-axSpA when compared with placebo. In addition, ixekizumab was associated with significant improvements in major secondary endpoints including Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity (BASDAI), sacroiliac joint inflammation (SIJ) as assessed by MRI (week 16) and the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score. Full findings will be presented at a future scientific meeting and published in a peer-reviewed journal.
“The COAST-X results offer compelling evidence that [ixekizumab] could provide a much-needed new alternative if approved for this patient population,” said clinical investigator for the program, Atul Deodhar, MD, professor of medicine at Oregon Health & Science University
Based on these results, the Company plans to submit an abbreviated New Drug Application for the nr-axSpA indication to the Food and Drug Administration in 2019; an application for approval in radiographic axSpA is currently under review.
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