Eli Lilly and Company has announced that Taltz (ixekizumab) met the primary and all key secondary endpoints in COAST-V, a Phase three study evaluating the safety and efficacy of Taltz for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (axSpA). The trial included a placebo arm and an active control arm (adalimumab) for comparison with placebo, and studied patients who had never received a biologic disease-modifying anti-rheumatic drug (bDMARD).
Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks, when compared to placebo. COAST-V is the first registration trial to use ASAS40 as the primary endpoint, compared to the standard endpoint of ASAS20.
AS is one type of spondyloarthritis that affects the pelvic joints and spine, and can be characterised by chronic inflammatory back pain, stiffness and impaired function and mobility. Of those affected by AS, approximately 80 percent will experience symptoms before the age of 30.
Dr. Lotus Mallbris, vice president and immunology platform leader at Lilly Bio-Medicines, comments: “Many people with this chronic, debilitating disease are still searching for an effective treatment. These initial results suggest that Taltz, if approved for this indication, may have the potential to help people with this challenging disease. At Lilly, the unmet needs of people living with autoimmune diseases drive our commitment to continue investing in novel science, developing medicines that may reduce the burden of disease and aim to raise the bar for treatment expectations.”
COAST-V is a multicentre, randomised, double blind, 16-week study, followed by long-term evaluation of efficacy and safety of ixekizumab in biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve patients with AS. Patients were required to have an established diagnosis of AS with active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Numeric Rating Scale (NRS) score more than or equal to four, and a total back pain NRS score also more than or equal to four.
During the study, ixekizumab -treated patients received a starting dose of 80mg or 160mg, followed by one of two dosing regimens: either 80mg administered subcutaneously once every two weeks or 80mg administered subcutaneously once every four weeks. Adalimumab at the approved dose of 40mg, administered subcutaneously every two weeks, was selected as the active control for comparison with placebo. The COAST-V study will also evaluate the long-term efficacy and safety of ixekizumab in patients with AS up to one year.
In COAST-V, the incidence of treatment-emergent adverse events was similar with Taltz compared with placebo. The most common adverse events observed were consistent with the Phase three studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Lilly plans to submit detailed data from COAST-V for disclosure at scientific meetings and in peer-reviewed journals later this year. The company plans to submit for regulatory approvals pending additional data from the ongoing Taltz development program later this year.
Taltz is currently approved for the treatment of adults with active psoriatic arthritis, and for those with moderate to severe plaque psoriasis that are candidates for systemic therapy or phototherapy. Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.