New 12-week findings from a head-to-head phase 4 trial showed the Eli Lilly product's benefit for plaque psoriasis clearance.
Andrew Blauvelt, MD, MBA
New data comparing ixekizumab (Taltz) to guselkumab (Tremfya) showed former’s superiority to the latter in treating patients to achieved complete skin clearance in 12 weeks, in a trial assessing the competitor drugs’ efficacy in patients with moderate to severe plaque psoriasis.
In this first-ever head-to-head comparison of an interleukin 17A (IL-17A) and IL-23/p19 inhibitor for patients with plaque psoriasis—conducted by Eli Lilly and Company—ixekizumab reported superiority in its rate of treated patients achieving complete skin clearance as per Psoriasis Area Severity Index (PASI) 100 scores at week 12.
The phase 4 IXORA-R trial, which is ongoing through week 24, also showed the therapy’s superiority in several secondary endpoints.
Investigators assessed 1027 enrolled patients with moderate to severe plaque psoriasis in the comparative trial. Patients were randomized to either ixekizumab or guselkumab at the approved dose for 24 weeks.
The primary endpoint of superiority for ixekizumab compared to guselkumab in proportion of patients to achieve complete skin clearance per PASI 100 was measured at 12 weeks. Investigators also assessed for key secondary endpoints of superiority over guselkumab in proportion of patients achieving PASI 75 at week 2, PASI 90 at weeks 4 and 8, PASI 100 at weeks 4, 8, and 24, PASI 50 at week 1, and static Physician’s Global Assessment (sPGA) score of 0 at week 12.
At week 12, patients on ixekizumab reported statistically significant higher improvements than those on guselkumab per PASI 100 (41.3% vs 24.9%; P <.001). Patients had also achieved all major secondary endpoints up to week 12 (P <.001).
In the trial data observed thus far, the 2 drugs’ safety profiles were consistent with those previously reported. Lilly intends to share results of the trial’s key remaining secondary endpoints at 24 weeks in 2020.
Lead study investigator Andrew Blauvelt, MD, MBA, a dermatologist and president of Oregon Medical Research Center in Portland, OR, explained the significance of the 12-week findings—as well as the promising findings reported as early as week 1 of the phase 4 trial.
“"Healthcare providers and patients value speed of response when evaluating treatment options for moderate to severe plaque psoriasis," Blauvelt said in a statement.
Rhonda Pacheco, PharmD, global brand development leader of immunology at Lilly, expressed confidence in the findings indicating that ixekizumab can provide significant levels of skin clearance early into the treatment of psoriasis.
“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," Pacheco said.