Eli Lilly and Company (NYSE: LLY) announced today Taltz (ixekizumab) met the primary and all major secondary endpoints up to week 12 in the Phase 4 IXORA-R study, which evaluated the efficacy and safety of Taltz versus TREMFYA (guselkumab) in people living with moderate to severe plaque psoriasis (PsO).
The IXORA-R trial is the first completed head-to-head (H2H) trial between an IL-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint.
At 12 weeks, Taltz met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to TREMFYA as measured by PASI 100. In addition, Taltz met all major secondary endpoints up to week 12, which include superiority over TREMFYA in the proportion of patients achieving PASI 75 at Week 2, PASI 90 at Weeks 4 and 8, PASI 100 at Weeks 4 and 8, static Physician’s Global Assessment (sPGA) 0 at Week 12 and PASI 50 at Week 1. Lilly plans to share results on the remaining key secondary endpoint of proportion of patients achieving PASI 100 at 24 weeks in 2020.
“Completely clear skin and rapid relief of symptoms are possible for many people living with moderate to severe plaque psoriasis, and should be two topics dermatologists discuss with their patients,” said Andrew Blauvelt, M.D., M.B.A., dermatologist and president of Oregon Medical Research Center in Portland, OR. “Head-to-head data like these are important and will help inform individual treatment goal discussions between healthcare providers and their patients.”
A total of 1,027 patients with moderate to severe plaque psoriasis were enrolled in the study to evaluate the efficacy and safety of Taltz compared to TREMFYA. Participants were randomized to receive Taltz (160 mg at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks) or TREMFYA (100 mg administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter) for a total of 24 weeks, with the primary analysis conducted at 12 weeks.
“Lilly’s goal is to raise the treatment bar for people living with psoriasis,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “And research shows that patients want clear skin and rapid improvements. We’re pleased to see that Taltz helped more people achieve 100 percent skin clearance compared to TREMFYA at week 12. These positive results reinforce that Taltz is an important treatment option for people with this disease.”
In IXORA-R, the safety profile of Taltz was consistent with previously reported results. No new safety signals were detected.
Lilly plans to submit detailed data from the IXORA-R study for disclosure at scientific meetings and in peer-reviewed journals.
Source: Company Press Release