Maintenance of skin clearance with ixekizumab treatment of psoriasis: Three-year results from the UNCOVER-3 study

Abstract

Psoriasis is a chronic disease that may require long-term treatment. Ixekizumab (IXE), which is a high-affinity monoclonal antibody that selectively targets interleukin 17A, is an approved therapy for patients with moderate-to-severe plaque psoriasis. To evaluate the efficacy and safety of IXE through 156weeks from the UNCOVER-3 study in patients who were treated with the recommended dose regimen (160mg of IXE at week 0, 80mg every 2weeks up to week 12, and 80mg every 4weeks thereafter). Patients randomized to IXE every 2weeks, IXE every 4weeks, etanercept twice weekly, or placebo were switched to IXE every 4weeks during the long-term extension period. Efficacy data were summarized by using the as-observed, multiple imputation, and modified nonresponder imputation methods. At week 156, 80.5% of patients had achieved at least a 75% improvement from baseline in their Psoriasis Area Severity Index (PASI) score, 66.0% had achived at least a 90% improvement from baseline in their PASI score, and 45.1% had achieved a 100% improvement from baseline in their PASI score with use of the modified nonresponder imputation method, and 97.2% and 86.2% of patients had achived at least a 75% improvement from baseline in their PASI score with use of the as-observed and multiple imputation methods, respectively. Similar response rates were observed in patients with baseline scalp, nail, or palmoplantar involvement. No new safety signals were identified through year 3. No placebo or active comparison after week 12. IXE sustained high responses with clearance of skin and nail lesions, with no new safety concerns through 3years.