Eli Lilly is planning to seek another regulatory approval for Taltz after the medication hit the primary and secondary endpoints in a Phase III study for the treatment of non-radiographic axial spondyloarthritis.
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Eli Lilly is planning to seek another regulatory approval for Taltz after the medication hit the primary and secondary endpoints in a Phase III study for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA).
Indianapolis-based Eli Lilly said Taltz (ixekizumab) hit the mark with all primary and secondary endpoints in the COAST-X trial in nr-axSpA patients with objective signs of inflammation who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. Data from the trial is being presented at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals Annual Meeting in Atlanta.
Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the spine skeleton. It is estimated that the disease affects 4.5 million adults worldwide, Eli Lilly said. The two subsets of the disease, r-axSpA and nr-axSpA, share similar clinical features but the biologic treatment options for nr-axSpA are more limited, the company added.
Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. In inflammatory-related issues, IL-17A is a common target. If approved for this latest indication, Taltz would become the first IL-17A antagonist approved for non-radiographic axSpA, Rhonda Pacheco, global brand development leader for immunology at Lilly said in a statement.
In August, Taltz won approval for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). That market the third approval for the medication. Taltz was first approved for treating psoriasis in 2016. In December 2017, Taltz was approved for the treatment of adults with psoriatic arthritis, a type of arthritis that attacks adults who have psoriasis.
In the placebo-controlled Phase III COAST-X study, Taltz improved the signs and symptoms of non-radiographic axSpA as measured by ASAS40, as well as reduced inflammation on MRI, an important objective measure of disease activity, Eli Lilly said.
In the COAST-X trial, 35% of Taltz-treated patient treated every four weeks and 40% of Taltz patients treated every two weeks achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response, compared to 19 percent of patients treated with placebo. These results were considered statistically significant, Eli Lilly said. At 52 weeks, 30% of patients treated with Taltz every four weeks and 31% of patients treated with Taltz every two weeks achieved ASAS40 response, compared to 13% of patients treated with placebo.
The overall safety profile of Taltz was consistent with previously reported results, with no new or unexpected safety findings, the company noted.
