Eli Lilly announced positive Phase 3 data for Taltz (ixekizumab) supporting the safety and efficacy of the drug in the treatment of ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (axSpA).
Taltz met the primary and major secondary endpoints in COAST-V, a multicenter, randomized, double-blind, active- and placebo-controlled study. In the study, Taltz (80mg or 160mg starting dose) was compared with adalimumab (40mg) and placebo among AS patients who had never been treated with a biologic disease-modifying anti-rheumatic drugs (bDMARD).
Taltz showed a statistically significant improvement in the signs and symptoms of AS, as seen by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16 vs placebo.
Regarding safety, the incidence of treatment-emergent adverse events was similar in the Taltz and placebo arms. The most frequent events reported were consistent with those seen in the Phase 3 studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
The COAST-V study will also assess the long-term safety and efficacy of Taltz in patients with AS up to 1 year. The COAST clinical program includes three 1-year studies: COAST-V, COAST-W, and COAST-X.
Taltz, a humanized interleukin-17A antagonist, is currently approved to treat adults with active psoriatic arthritis and adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is supplied as 80mg single-dose autoinjectors or prefilled syringes in 1-, 2-, and 3-count cartons.
For more information call (800) 545-5979 or visit Taltz.com.