Patients with moderate- to severe plaque psoriasis who continued to receive Taltz® (ixekizumab) maintained high levels of skin clearance with no unexpected safety outcomes for up to five years of treatment, according to new data Eli Lilly and Company is presenting at the World Congress of Dermatology (WCD) in Milan, Italy.
"Of patients who continued to take Taltz through five years in the extension period of this study, more than 90 percent maintained significant skin clearance as measured by PASI 75 and almost half of patients maintained completely clear skin," says Craig Leonardi, MD, lead investigator of the study and adjunct professor of dermatology at St. Louis University School of Medicine. "These results demonstrate that patients taking Taltz can achieve sustained skin clearance over the five-year treatment period."
Patients who were static Physician's Global Assessment (sPGA) 0/1 responders at Week 12 and who completed 60 weeks of treatment could enter the open-label extension period of UNCOVER-1 (n=110). In the extension period of the study, Taltz demonstrated sustained response from Week 60 through Week 264 in patients who continuously received on-label dosing (160 mg starting dose, 80 mg every two weeks [Q2W] through Week 12, and every four weeks [Q4W] thereafter). Response rates were maintained over the five-year period, with Psoriasis Area and Severity Index (PASI) 75, 90 and 100 response rates of 94.3 percent, 81.8 percent and 46.6 percent, respectively at week 264.
During Weeks 60-264, treatment-emergent adverse events were consistent with previous studies of Taltz from the UNCOVER program. Additionally, there were no new or unexpected safety findings during the extension period. Four-year data from UNCOVER-3 will also be presented at the WCD.
The Taltz safety profile has been studied in 13 clinical trials in moderate- to severe plaque psoriasis with a total exposure of more than 17,000 patient-years as part of the Taltz clinical trial program.