Lilly announces positive top-line Phase 3 results for Taltz (ixekizumab) in ankylosing spondylitis (radiographic axial spondyloarthritis).
Eli Lilly’s Taltz (ixekizumab) met the primary and all key secondary endpoints in COAST-V, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (axSpA).
The trial included a placebo arm and an active control arm (adalimumab) for comparison with placebo, and studied patients who had never received a biologic disease-modifying anti-rheumatic drug (bDMARD).
Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks, when compared to placebo. COAST-V is the first registration trial to use ASAS40 as the primary endpoint, compared to the standard endpoint of ASAS20.
AS is one type of spondyloarthritis that affects the pelvic joints and spine, and can be characterized by chronic inflammatory back pain, stiffness and impaired function and mobility.1 Of those affected by AS, approximately 80 percent will experience symptoms before age 30.2
“Many people with this chronic, debilitating disease are still searching for an effective treatment,” said Dr. Lotus Mallbris, vice president and immunology platform team leader, Lilly Bio-Medicines. “These initial results suggest that Taltz, if approved for this indication, may have the potential to help people with this challenging disease.”
In COAST-V, the incidence of treatment-emergent adverse events was similar with Taltz compared with placebo. The most common adverse events observed were consistent with the Phase 3 studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Lilly plans to submit detailed data from COAST-V for disclosure at scientific meetings and in peer-reviewed journals later this year. The company plans to submit for regulatory approvals pending additional data from the ongoing Taltz development program later this year.
Taltz is approved for the treatment of adults with active psoriatic arthritis. Taltz is also approved to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
(Source: Eli Lilly and Co.)
Filed Under: Drug Discovery