Published 14 February 2018
Eli Lilly announced that Taltz (ixekizumab) has 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
Lilly Bio-Medicines immunology platform team leader and vice president Dr Lotus Mallbris said: “Many people with this chronic, debilitating disease are still searching for an effective treatment. These initial results suggest that Taltz, if approved for this indication, may have the potential to help people with this challenging disease.”
“At Lilly, the unmet needs of people living with autoimmune diseases drive our commitment to continue investing in novel science, developing medicines that may reduce the burden of disease and aim to raise the bar for treatment expectations.”
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.
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 Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (axSpA). Patients were required to have an established diagnosis of AS with active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Numeric Rating Scale (NRS) score ≥4 and a total back pain NRS score ≥4.
Source: Company Press Release