Eli Lilly announces Taltz meets primary, secondary endpoints in IXORA-R trial
Eli Lilly announced Taltz 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 in people living with moderate to severe plaque psoriasis, or PsO. The IXORA-R trial is the first completed head-to-head, or H2H, trial between an IL-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index, or 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, or 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. 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 or Tremfya for a total of 24 weeks, with the primary analysis conducted at 12 weeks. 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.