Eli Lilly's Taltz (ixekizumab) med has met the primary and all major secondary endpoints up to week 12 in the Phase 4 IXORA-R study. The study evaluated the efficacy and safety of Taltz versus Johnson & Johnson's Tremfya (guselkumab) in people living with moderate to severe plaque psoriasis (PsO). The trial is the first completed head-to-head 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.
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.
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