Results from a phase 3 study show that ixekizumab improved signs and symptoms of ankylosing spondylitis (AS) at 16 weeks in patients who had an inadequate response to 1 or 2 tumor necrosis factor (TNF) inhibitors.
The COAST-W study (ClinicalTrials.gov identifier: NCT02696798) is a multicenter, randomized, double-blind, placebo-controlled 16-week study examining the efficacy and safety of ixekizumab in patients who had an inadequate response or were intolerant to 1 or 2 TNF inhibitors.
Participants were treated with subcutaneous ixekizumab 80 mg every 2 or 4 weeks or placebo. Participants had an established diagnosis of AS with active disease defined with a Bath Ankylosing Spondylitis Disease Activity Index score ≥4 and a total back pain score ≥4.
Ixekizumab met the primary efficacy end point of improved signs and symptoms at 16 weeks compared with placebo, measured by the proportion of patients who achieved a 40% improvement in Assessment of Spondyloarthritis International Society criteria (ASAS40).
“As we’re pursuing therapeutic development for AS, we’re aiming to hold our treatment to a higher standard, which is why we designed our COAST clinical development program to be the first to use ASAS40 as the primary endpoint to define treatment success,” Lotus Mallbris, MD, vice president, Immunology Development, Eli Lilly and Company, told Rheumatology Advisor.
In addition, the incidence of serious adverse events was similar with ixekizumab compared with placebo.
“These positive results, in combination with previous results from the phase 3 COAST-V study, provide further support for [ixekizumab] as a potential treatment option for patients with AS, including those who have had an inadequate response to treatment with TNF inhibitors, a difficult-to-treat population,” Dr Mallbris stated.
Based on positive results from the COAST-W and COAST-V studies, Eli Lilly and Company plans to submit ixekizumab for US regulatory approval in AS later this year.
Lilly announces positive top-line results for second phase 3 study of Taltz® (ixekizumab) in ankylosing spondylitis (radiographic axial spondyloarthritis) for TNF inhibitor-experienced patients [press release]. Indianapolis, Indiana: Eli Lilly and Company. https://investor.lilly.com/news-releases/news-release-details/lilly-announces-positive-top-line-results-second-phase-3-study. June 28, 2018. Accessed June 28, 2018.