15 February 2018 - - Indianapolis, Indiana-based global pharmaceuticals specialist Eli Lilly and Company's (NYSE: LLY) 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 company said.
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.
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.
COAST-V is a multicenter, randomized, double-blind, active and placebo-controlled 16-week study followed by long-term evaluation of efficacy and safety of ixekizumab in biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve patients with as AS.
Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.
It is approved for the treatment of adults with active psoriatic arthritis, and adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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