Eli Lilly and Co., presented positive results from two phase 3 studies of ixekizumab for ankylosing spondylitis treatment at the American College of Rheumatology/Association of Rheumatology Health Professionals 2018 Annual Meeting in Chicago, Oct. 23.
In both studies, ixekizumab significantly improved the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 over 16 weeks compared to placebo. ASAS40 represents at least a 40 percent improvement in disease symptoms, such as pain and inflammation.
Coast-V is the first successful AS trial to use ASAS40 compared to the standard ASAS20 endpoint. The study comprised 341 patients who had never received a biologic disease-modifying anti-rheumatic drug. Patients were treated with 80 milligrams of ixekizumab subcutaneously either every four weeks or every two weeks, adalimumab or placebo.
At 16 weeks:
- 48 percent of patients treated with ixekizumab every four weeks achieved ASA40
- 52 percent of patients treated with ixekizumab every two weeks achieved ASA40
- 18 percent of patients treated with placebo achieved ASAS40
Coast-W comprised 316 AS patients who had an inadequate response or were intolerant to one or two tumor necrosis factor inhibitors. Patients were treated with 80 milligrams of ixekizumab subcutaneously either every four weeks or every two weeks or placebo.
At 16 weeks:
- 25 percent of patients treated with ixekizumab every four weeks achieved ASA40
- 31 percent of patients treated with ixekizumab two weeks achieved ASA40
- 13 percent of patients treated with placebo achieved ASAS40
Based on the positive results of these studies, Eli Lilly plans to submit for U.S. regulatory approval in AS/radiographic axial spondyloarthritis.