Ixekizumab demonstrated a statistically significant improvement in the signs and symptoms of ankylosing spondylitis compared with placebo, according to an Eli Lilly press release.
The findings are the result of the phase 3 COAST-W study, a multicenter, randomized, double-blind 16-week trial that evaluated the safety and efficacy of ixekizumab (Taltz, Eli Lilly) for the treatment of AS, the company said. The study included patients who have an intolerance of, or had an inadequate response to, TNF inhibitors.
“These positive results, in combination with previous results from the phase 3 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,” Lotus Mallbris, MD, PhD, vice president of immunology development for Eli Lilly, said in the release. “By using [Assessment of Spondyloarthritis International Society 40 (ASAS40)] as the primary endpoint in our clinical development program, we hope to establish a higher treatment target goal for AS patients.”
Ixekizumab demonstrated a statistically significant improvement in the signs and symptoms of AS compared with placebo, according to a press release.
According to Eli Lilly, COAST-W is part of those clinical development program for ixekizumab for the treatment of AS, and is the first study in that program to use ASAS40 as the primary endpoint, rather than the more common ASAS20.
In the study, researchers compared the efficacy and incidence of serious adverse events between patients treated with 80 mg of ixekizumab or placebo. According to the researchers, the occurrence of adverse events was similar between the two groups.
Eli Lilly plans to release data from the COAST-W trial for peer-reviewed publications and for discourse at scientific meetings later this year, according to the release. It also plans to submit the drug’s use in the treatment of AS for regulatory approval later this year.
Ixekizumab is currently approved for the treatment of adults with psoriatic arthritis, as well as those with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
“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,” Mallbris said in the release. – by Jason Laday
Disclosure: Mallbris reports employment with Eli Lilly.