The Korean branch of Eli Lilly said it has presented the phase 4 IXORA-R study, which compared Taltz against Tremfya in people living with moderate to severe plaque psoriasis.
Lilly's psoriasis treatment Taltz
Taltz met the primary and all major secondary endpoints up to week 12 in phase 4 IXORA-R study, which evaluated the efficacy and safety of Taltz versus Tremfya in people living with moderate to severe plaque psoriasis," the company said. "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."
In the 12th week, 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.
The Taltz treatment group achieved 41.3 percent PASI 100 at week 12 and was statistically significant at improving skin compared to the Tremfya treatment group, which achieved 24.9 percent.
Taltz also 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.
"Healthcare providers and patients value speed of response when evaluating treatment options for moderate to severe plaque psoriasis," said Andrew Blauvelt, dermatologist and president of Oregon Medical Research Center. "The results from the IXORA-R study demonstrate that Taltz was effective in helping more patients achieve completely clear skin by week 12, with a 50 percent improvement in skin plaques seen as early as week 1."
Lilly's global brand development leader for immunology Rhonda Pacheco, also said, "As new medicines become available for people living with psoriasis, there's an increasing need to directly compare the efficacy and safety of these treatments to help healthcare providers and patients make informed treatment decisions."
Such results demonstrate that Taltz can provide high levels of skin clearance early in treatment for people with psoriasis, Pacheco added.
A total of 1,027 patients with moderate to severe plaque psoriasis participated in the study to evaluate the efficacy and safety of Taltz compared to Tremfya. The company randomly assigned patients to receive either Taltz or Tremfya at the approved dose for 24 weeks, with the primary analysis conducted at the 12th week.
The safety profiles of Taltz and Tremfya were also consistent with those previously reported for both treatments. As the IXORA-R study is ongoing, not all data will be presented at this meeting to prevent unblinding for investigators and participants. Lilly plans to share results on the remaining key secondary endpoint of the proportion of patients achieving PASI 100 at the 24th week in 2020.
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