Yesterday, Eli Lilly announced that its anti–IL-17 monoclonal antibody ixekizumab (Taltz) met the primary and key secondary endpoints in the phase 3 COAST-V trial evaluating its safety and efficacy in ankylosing spondylitis.
Yesterday, Eli Lilly announced that its anti—IL-17 monoclonal antibody ixekizumab (Taltz) met the primary and key secondary endpoints in the phase 3 COAST-V trial evaluating its safety and efficacy in ankylosing spondylitis (AS), a type of spondyloarthritis that affects the pelvic joints and spine, and is characterized by chronic inflammatory back pain, stiffness, and impaired function and mobility.
The trial, conducted in biologic-treatment naïve patients, included an active control arm of patients receiving adalimumab and a placebo arm. Patients receiving ixekizumab had a statistically significant improvement in the signs and symptoms of AS, as measured by the proportion of patients who achieved the Assessment of Spondyloarthritis International Society criteria for a 40% improvement (ASAS40) at week 16 compared with patients who achieved the same response while receiving the placebo. Notably, COAST-V is the first registered trial to use ASAS40 as the primary endpoint, rather than the standard endpoint of ASAS20.
Eli Lilly reports that the incidence of treatment emergent adverse events (AEs) was comparable with ixekizumab compared with placebo in this trial, and were consistent with prior phase 3 studies of ixekizumab for the treatment of moderate to severe plaque psoriasis (PP) and active psoriatic arthritis (PA), which included injection-site reactions, upper respiratory infections, nausea, and tinea infections.
“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,” said Lotus Mallbris, MD, vice president and immunology platform leader for Lilly Bio-Medicines.
Currently, ixekizumab is approved for the treatment of PP and moderate to severe PA in adults, and in 2017, ixekizumab generated sales of $559.2 million. By potentially expanding its indication to include AS, Lilly could vie for more of the market share for inflammatory diseases against the current market leader, AbbVie’s Humira (adalimumab), and the 4 other FDA-approved anti—tumor necrosis factor therapies that treat AS: etanercerpt, infliximab, golimumab, and certolizumab. Additionally, 1 IL-17 inhibitor, secukinumab, is approved to treat AS. Lilly plans to submit data from this trial at scientific meetings and in peer-reviewed journals later in 2018. According to Lilly, pending additional data from the ongoing ixekizumab development program, Lilly will seek submission for regulatory approvals this year.