Eli Lilly and Company presented positive data from two Phase III clinical trials at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago yesterday.
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Eli Lilly and Company presented positive data from two Phase III clinical trials at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago yesterday. The data is related to the company’s Taltz (ixekizumab) in differing populations of patients with radiographic axial spondyloarthritis (asxSpA).
Spondyloarthropathies are a group of chronic inflammatory rheumatic diseases that have features that overlap. Axial SpA affects the spine and sacroiliac joints. Axial SpA can be diagnosed as either ankylosing spondylitis (AS) or non-radiographic axial SpA (nr-axSpA), depending on the presence of radiographic sacroiliitis.
The first study, COAST-V, included 341 patients. Patients were treated with 80 mg of Taltz subcutaneously either every four weeks or every two weeks, AbbVie’s Humria (adalimumab), or placebo. Patients receiving Taltz at varying intervals hit the trial’s primary endpoints.
At 16 weeks, 48 percent who received Taltz every four weeks, 52 percent who received Taltz every two weeks, and 18 percent on placebo achieved ASAS40, the primary endpoint of the study.
ASAS40 is the Assessment of Spondyloarthritis International Society 40, representing at least a 40 percent improvement in disease signs and symptoms, including pain, inflammation and function.
“Taltz demonstrated significant improvements in disease activity, functional disability, and spinal and sacroiliac joint inflammation among patients with AS,” stated Desiree van der Heijde, professor of rheumatology at Leiden University Medical Center.
The second trial, COAST-W, looked at 316 patients with AS who had an inadequate response or were intolerant to one or two tumor necrosis factor (TNF) inhibitors. Patients were given 80 mg of Taltz subcutaneously either every four weeks or every two weeks, or placebo. At week 16, 25 percent of patients who received Taltz every four weeks, 31 percent who received Taltz every two weeks, and 13 percent of patients getting placebo, achieved ASAS40, the primary endpoint.
Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine, inhibiting its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine indicated in normal inflammatory and immune responses.
COAST-V data has been published in The Lancet. COAST-W data has been published by Arthritis & Rheumatology.
Based on the data from these two studies, Eli Lilly expects to submit to the US. Food and Drug Administration (FDA) for approval before the end of this year.
Taltz is approved for active psoriatic arthritis and plaque psoriasis.
At the same meeting on Monday, Lilly and Incyte presented findings from an updated integrated safety analysis of Olumiant (baricitinib) from an ongoing long-term extension study of rheumatoid arthritis (RA) patients treated up to six years.
“Overall, the data show that Olumiant maintained its recorded safety profile,” said Terence Rooney, senior medical director, Lilly Bio-Medicines, in a statement. “This integrated analysis reflects Lilly’s commitment to patient safety and our goal to ensure that the benefits and risks of our medicines are well-understood by the healthcare community.”
The long-term study included all patients with active RA who received the drug during eight randomized clinical trials—four Phase III, three Phase II, and one Phase Ib, and one LTE study. Dose responses were analyzed based on the four Phase II/III trials where the patients received the 2-mg or 4-mg doses of Olumiant, and included data form the LTE trial. The 4-mg dose is not approved for use in the U.S.
In total, 3,492 patients received Olumiant, with more than 75 percent treated for at least one year, half treated for at least two and a half years.
No new adverse events were observed or seem to increase with longer-term treatment.
