ACR 2018: Lilly Announces Positive Results for Two Phase 3 Studies of Taltz (ixekizumab) in Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
COAST-V is the first successful AS trial to use ASAS40 as the primary endpoint -- COAST-W is the first AS trial to specifically focus on patients who had failed one or two tumor necrosis factor (TNF) inhibitors or are intolerant to a TNF inhibitor and to generate data on spinal MRI inflammation in this patient population -
INDIANAPOLIS,? Eli Lilly and Company (NYSE: LLY) announced today that the company will present positive findings from two Phase 3 studies, COAST-V and COAST-W, in adults with ankylosing spondylitis (AS), also referred to as radiographic axial spondyloarthritis (axSpA), at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago on October 23. The analyses are part of a clinical development program that aims to evaluate Taltz? (ixekizumab) across various populations of patients with AS.
"Many people with AS are either untreated or still searching for an effective treatment," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "By using ASAS40 as the primary endpoint in our clinical development program, we hope to establish a higher treatment bar for AS patients."
In both studies, Taltz demonstrated a statistically significant and clinically meaningful improvement in proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) over 16 weeks compared to placebo. ASAS40 represents at least a 40-percent improvement in disease signs and symptoms such as pain, inflammation and function. COAST-V is the first successful trial in AS to use ASAS40, a stringent clinical measure indicating a high degree of clinical improvement as the primary endpoint, compared to the standard endpoint of ASAS20. COAST-W is the first AS study to specifically focus on the difficult-to-treat population of patients who had an inadequate response to one or two tumor necrosis factor (TNF) inhibitors (90 percent of enrolled patients) or intolerance to a TNF inhibitor (10 percent).
COAST-V Analysis of Study Results
COAST-V, which included 341 patients, is the first Phase 3 study of Taltz among patients with AS who had never received a biologic disease-modifying anti-rheumatic drug (bDMARD). It also is the first study to include both a placebo control arm and active reference arm (adalimumab). During the study, patients were treated with 80 mg of Taltz subcutaneously either every four weeks or every two weeks (following 80 mg or 160 mg starting dose at Week 0), adalimumab, or placebo.At 16 weeks, 48 percent of patients treated with Taltz every four weeks, 52 percent of patients treated with Taltz every two weeks and 18 percent of patients treated with placebo achieved ASAS40, the primary endpoint of the study.
Taltz also demonstrated a statistically significant improvement on the following secondary endpoints, achieving the following response rates at 16 weeks:
- ASAS20: 64 percent of patients treated with Taltz every four weeks, 69 percent of patients treated with Taltz every two weeks and 40 percent of patients treated with placebo achieved ASAS20.
- BASDAI50: 42 percent of patients treated with Taltz every four weeks, 43 percent of patients treated with Taltz every two weeks and 17 percent of patients treated with placebo achieved a Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50).
- MRI Spine SPARCC CFB: patients treated with Taltz every four weeks experienced a -11.0 change from baseline (CFB) in MRI spine SpA Research Consortium of Canada (SPARCC) score, patients treated with Taltz every two weeks experienced a -9.6 SPARCC CFB and patients treated with placebo experienced a -1.5 SPARCC CFB.
- ASAS20: 48 percent of patients treated with Taltz every four weeks, 47 percent of patients treated with Taltz every two weeks and?30 percent of patients treated with placebo achieved ASAS20.
- BASDAI CFB: patients treated with Taltz every four weeks and patients treated with Taltz every two weeks experienced a statistically significant reduction in disease activity compared to placebo as measured by BASDAI (-2.2?0.2 , -2.1?0.2 and -0.9?0.2 respectively).
- MRI SPARCC Spine CFB: patients treated with Taltz every four weeks and patients treated with Taltz every two weeks experienced a statistically significant reduction in spinal MRI inflammation compared to placebo as measured by the CFB in MRI spine SPARCC score ( -3.0, -4.0 and 3.3, respectively).
Refer to: | Jackie Shelton, sheltonj@lilly.com; 317-719-5928 (media) |
Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (investors) |
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SOURCE Eli Lilly and Company