Results Released from Ixekizumab Phase III Trials

June 10, 2016
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.

An article published in the New England Journal of Medicine (NEJM) analyzes the results of Phase III clinical trials conducted with Eli Lilly’s psoriasis treatment, Taltz (ixekizumab). Ixekizumab, a monoclonal antibody against interleukin (IL)-17A, was recently granted FDA approval for the treatment of adults with moderate-to-severe plaque psoriasis.

The NEJM article, published on June 8, 2016, provides an overview of UNCOVER-1, UNCOVER-2, and UNCOVER-3 trials, which tested the clinical efficacy and safety of ixekizumab in patients, compared to a placebo. In UNCOVER-2 and UNCOVER-3 trials, additional cohorts were given injections of etanercept twice weekly. The studies examined the effectiveness of ixekizumab in clearing skin plaques over a 12-week and 60-week period. Patients were randomized and received doses of ixekizumab every two or four weeks.

Results indicated that the drug was superior to both placebo and etanercept in clearing skin plaques. In UNCOVER-1, 81.8% of patients treated with ixekizumab achieved static Physicians Global Assessment (sPGA) of 0 or 1 at 12 weeks. Through 60 weeks, results from UNCOVER-1 and UNCOVER-2 indicated 78.3% of patients maintained sPGA of 0 or 1. Results from UNCOVER-3 indicated 74.5% of patients achieved sPGA of 0 or 1 at the conclusion of 60 weeks.

While results from the trials showed ixekizumab was effective at clearing skin plaques, the authors indicate it is unclear how the treatment will affect patients over long periods of time. Researchers also noted, 11 patients reported inflammatory bowel disease while being treated with ixekizumab, and three reported the disease while taking a placebo. The authors note that this indicates that more research may need to be done to examine the relationship between inflammatory bowel disease and IL-17A inhibitors.

Source: Eli Lilly, NEJM