Data from Pharmawand - Curated by EPG Health - Date added 12 June 2019
Eli Lilly and Company announced the company will present positive, five-year Phase III data for Taltz (ixekizumab). Patients with moderate- to- severe plaque psoriasis who continued to receive Taltz maintained high levels of skin clearance with no unexpected safety outcomes for up to five years of treatment. These data will be presented at the World Congress of Dermatology (WCD) in Milan, Italy on June 11.
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. Later this year, Lilly plans to announce the results from IXORA-R, a clinical trial designed to evaluate superiority between Taltz and Tremfya (guselkumab) in adult patients with moderate- to severe plaque psoriasis.