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Eli Lilly has announced positive results from COAST-X, a 52-week, placebo-controlled, phase 3 trial evaluating ixekizumab (Taltz) in biologic disease-modifying antirheumatic drug–naive patients with nonradiographic axial spondyloarthritis (nr-axSpA).
Ixekizumab met the primary endpoint of statistically significant improvement in nr-axSpA symptoms as measured by Assessment of Spondyloarthritis International Society 40 response at both week 16 and week 52, compared with patients who received placebo. The drug also met all secondary endpoints, including significant improvement in Ankylosing Spondylitis Disease Activity Score, significant improvement in Bath Ankylosing Spondylitis Disease Activity, proportion of patients achieving low disease activity, significant improvement in sacroiliac joint inflammation as assessed by MRI, and significant improvement in 36-Item Short Form Health Survey Physical Component Summary score.
The safety profile of ixekizumab was broadly similar to what has been seen in previous phase 3 trials; the most common adverse events include injection site reactions, upper respiratory tract infections, nausea, and tinea infections, the company said.
“Nonradiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients. The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population,” Atul A. Deodhar, MD, professor of medicine at Oregon Health & Science University, Portland, and clinical investigator for the COAST program, said in the press release.
Find the full press release on the Eli Lilly website.
Eli Lilly has announced positive results from COAST-X, a 52-week, placebo-controlled, phase 3 trial evaluating ixekizumab (Taltz) in biologic disease-modifying antirheumatic drug–naive patients with nonradiographic axial spondyloarthritis (nr-axSpA).
Ixekizumab met the primary endpoint of statistically significant improvement in nr-axSpA symptoms as measured by Assessment of Spondyloarthritis International Society 40 response at both week 16 and week 52, compared with patients who received placebo. The drug also met all secondary endpoints, including significant improvement in Ankylosing Spondylitis Disease Activity Score, significant improvement in Bath Ankylosing Spondylitis Disease Activity, proportion of patients achieving low disease activity, significant improvement in sacroiliac joint inflammation as assessed by MRI, and significant improvement in 36-Item Short Form Health Survey Physical Component Summary score.
The safety profile of ixekizumab was broadly similar to what has been seen in previous phase 3 trials; the most common adverse events include injection site reactions, upper respiratory tract infections, nausea, and tinea infections, the company said.
“Nonradiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients. The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population,” Atul A. Deodhar, MD, professor of medicine at Oregon Health & Science University, Portland, and clinical investigator for the COAST program, said in the press release.
Find the full press release on the Eli Lilly website.
Eli Lilly has announced positive results from COAST-X, a 52-week, placebo-controlled, phase 3 trial evaluating ixekizumab (Taltz) in biologic disease-modifying antirheumatic drug–naive patients with nonradiographic axial spondyloarthritis (nr-axSpA).
Ixekizumab met the primary endpoint of statistically significant improvement in nr-axSpA symptoms as measured by Assessment of Spondyloarthritis International Society 40 response at both week 16 and week 52, compared with patients who received placebo. The drug also met all secondary endpoints, including significant improvement in Ankylosing Spondylitis Disease Activity Score, significant improvement in Bath Ankylosing Spondylitis Disease Activity, proportion of patients achieving low disease activity, significant improvement in sacroiliac joint inflammation as assessed by MRI, and significant improvement in 36-Item Short Form Health Survey Physical Component Summary score.
The safety profile of ixekizumab was broadly similar to what has been seen in previous phase 3 trials; the most common adverse events include injection site reactions, upper respiratory tract infections, nausea, and tinea infections, the company said.
“Nonradiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients. The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population,” Atul A. Deodhar, MD, professor of medicine at Oregon Health & Science University, Portland, and clinical investigator for the COAST program, said in the press release.
Find the full press release on the Eli Lilly website.