Data were presented at the 5th Annual Maui Derm NP+PA Fall meeting from the phase 4 IXORA-R study, the first head-to-head ( H2H ) study between an IL-17A inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index ( PASI ) 100 score as the primary endpoint.
Ixekizumab ( Taltz ) met the primary endpoint of superiority versus Guselkumab ( Tremfya ) in the proportion of patients with moderate to severe plaque psoriasis achieving complete skin clearance as measured by PASI 100 at week 12, as well as key secondary endpoints. The study is ongoing through week 24.
The primary endpoint of the study was superiority for Ixekizumab compared to Guselkumab in the proportion of patients achieving complete skin clearance as measured by PASI 100 at week 12.
Key secondary endpoints included superiority over Guselkumab in the proportion of patients achieving PASI 75 at week 2, PASI 90 at weeks 4 and 8, PASI 100 at weeks 4, 8 and 24, static Physician's Global Assessment ( sPGA ) 0 at week 12 and PASI 50 at week 1.
Patients treated with Ixekizumab have demonstrated statistically significantly higher improvements than those treated with Guselkumab as measured by PASI 100 at week 12 ( 41.3% versus 24.9%, P less than 0.001 ).
Additionally, all major secondary endpoints up to week 12 were achieved ( P less than 0.001 ).
A total of 1,027 patients with moderate to severe plaque psoriasis were enrolled in the study to evaluate the efficacy and safety of Ixekizumab compared to Guselkumab.
Participants were randomized to receive Ixekizumab or Guselkumab at the approved dose for a total of 24 weeks, with the primary analysis conducted at 12 weeks.
In IXORA-R, the safety profiles of Ixekizumab and Guselkumab were consistent with those previously reported for both treatments.
The IXORA-R study has demonstrated that Ixekizumab was effective in helping more patients achieve completely clear skin by week 12, with a 50% improvement in skin plaques seen as early as week 1. ( Xagena )
Source: Eli Lilly, 2019