Phase 3 Data Show Ixekizumab Improves Non-Radiographic Axial Spondyloarthritis Symptoms

The COAST-X clinical trial program is evaluating ixekizumab across various population subsets of patients with axial spondyloarthritis.

Ixekizumab (Taltz, Eli Lilly) significantly improved the signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naive, according to new data from the phase 3 COAST-X study.

AxSpA is a chronic inflammatory disease that affects predominantly the sacroiliac joints and the axial skeleton. The COAST-X clinical trial program is evaluating ixekizumab across various population subsets of patients with axSpA.

“Non-radiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients,” clinical investigator Atul Deodhar, MD, professor of medicine at Oregon Health and Science University, said in a statement. “The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population.”

Ixekizumab, a monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine, inhibits its interaction with IL-17 receptor and the release of pro-inflammatory cytokines and chemokines, according to Lilly. It is currently 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.

In the 52-week study, which evaluated the safety and efficacy of ixekizumab in the treatment of nr-axSpA, the drug demonstrated statistically significant improvements in the signs and symptoms of the disease at both week 16 and week 52, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared with placebo. Ixekizumab also met the study’s major secondary endpoints at week 16 and week 52: significant improvement in Bath Ankylosing Spondylitis Disease Activity, proportion of patients achieving low disease activity, significant improvement in sacroiliac joint inflammation as assessed by MRI, and significant improvement in 36-Item Short Form Health Survey Physical Component Summary Score.

“We’re encouraged by the results of the COAST-X trial, which support our belief that Taltz could become the first IL-17A antagonist to be approved in the US for people with non-radiographic axSpA,” Christi Shaw, president of Lilly Bio-Medicines said in a statement. “The COAST-X data add to the growing body of evidence from our COAST program, which demonstrates that Taltz may work across the axSpA disease spectrum.”

The application for radiographic axSpA is currently under review with the FDA and regulatory action is expected later this year, according to Lilly.

Reference

Lilly Announces Positive Top-Line Results for COAST-X, a 52-Week Placebo-Controlled Study of Taltz (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis [news release]. Eli Lilly. https://investor.lilly.com/news-releases/news-release-details/lilly-announces-positive-top-line-results-coast-x-52-week. Accessed April 22, 2019.