Lilly’s Taltz Hit Primary and Secondary Endpoints in Ankylosing Spondylitis Trial
By Mark Terry
Eli Lilly and Company announced the results of its COAST-W Phase III clinical trial of Taltz (ixekizumab) to treat Ankylosing Spondylitis (AS). The trial met both primary and major secondary endpoints.
AS is a type of arthritis that primarily affects the spine, although it can affect other joints as well. It causes inflammation of the vertebra and can lead to severe and chronic pain and discomfort. In its most advanced cases, the inflammation can lead to ankylosis, new bone formation in the spine, which causes segments of the spine to fuse in a fixed, immobile position. It can also cause inflammation, pain and stiffness in the shoulders, hips, ribs, heels and small joints of the hands and feet. Sometimes the eyes are involved and in rare cases, the heart or lungs. Patients typically have symptoms before the age of 30.
Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine. It inhibits IL-17A’s interaction with the IL-17 receptor. IL-17A is a naturally occurring molecule involved in normal inflammatory and immune responses. Taltz prevents the release of pro-inflammatory cytokines and chemokines.
Taltz showed a statistically significant improvement in the symptoms of AS. It was measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks compared to placebo. The COAST-W program is the first to use ASAS40 across the program as the primary endpoint to define treatment success, instead of the traditional endpoint of ASAS20.
Serious adverse events were similar with Taltz compared to placebo. The most common side effects were consistent with other Phase III trials of the drug.
Lilly tested Taltz versus placebo in 300 patients with AS who didn’t respond to one or two TNF inhibitors, which was a standard treatment for inflammation.
“These positive results, in combination with previous results from the Phase III COAST-V study, provide further support for Taltz as a potential treatment option for patients with AS, including those who have had an inadequate response to treatment with TNF inhibitors, a difficult-to-treat population,” said Lotus Mallbris, vice president, Immunology Development at Lilly, in a statement. “By using ASAS40 as the primary endpoint in our clinical development program, we hope to establish a higher treatment target goal for AS patients. We look forward to sharing additional clinically meaningful data from this study, and remain committed to continuing our research to evaluate potential treatment options that deliver better outcomes for patients living with this disease.”
Taltz is currently approved for adults with active psoriatic arthritis, and for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It was approved for psoriatic arthritis in December 2017.
Lilly expects to submit detailed data from this trail at future scientific meetings and in peer-reviewed journals this year. It plans to submit to the U.S. Food and Drug Administration (FDA) for AS later this year.
Sales have been dropping for the drug, and faces stiff competition from Novartis’ first-to-market blockbuster Cosentyx.