Ixekizumab (IXE) is an appropriate long-term therapy for patients with psoriasis, with a high level of skin clearance and a consistent safety profile through 3 years, according to the results of the phase 3, randomized, double-blind, multicenter, UNCOVER-3 study (ClinicalTrials.gov identifier: NCT01646177) published in the Journal of the American Academy of Dermatology.
The investigators sought to evaluate the efficacy and safety of IXE through 156 weeks in patients who were randomly assigned to receive IXE 80 mg every 2 weeks (Q2W), IXE 80 mg every 4 weeks (Q4W), etanercept 50 mg twice weekly, or placebo. Both IXE groups received a 160-mg IXE dose at baseline. At week 12, all patients were switched to IXE Q4W for the long-term extension. After week 60, at the investigator’s discretion, patients could receive a dose adjustment to IXE Q2W. The current study focused on findings from patients who received the clinically recommended dosing regimen (ie, initial dose of IXE 160 mg, followed by IXE 80 mg Q2W up to week 12, then IXE 80 mg Q4W thereafter).
Efficacy data were summarized with the use of as-observed, multiple imputation (MI), and modified nonresponder imputation (mNRI) methods. At week 156, response rates were 80.5%, 66.0%, and 45.1% for Psoriasis Area and Severity Index (PASI) 75 (); PASI 90; and PASI 100 scores, respectively, using the mNRI method. Scores on PASI 75 were 97.2% and 86.2% using the as-observed and MI methods, respectively.
Similar response rates were observed in patients with baseline scalp, nail, or palmoplantar involvement. There were no new safety concerns identified through year 3.
Limitations of the study include the absence of a placebo or active comparison group after week 12. The investigators concluded that IXE treatment was associated with sustained high responses with clearance of skin and nail lesions, with no new safety concerns reported through 3 years of study. In fact, after 3 years of IXE therapy, a majority of patients sustained a PASI 90 response, and more than 50% had PASI 100. Thus, IXE can be considered a reasonable long-term treatment option for patients with moderate to severe plaque psoriasis.
Leonardi C, Maari C, Philipp S, et al. Maintenance of skin clearance with ixekizumab treatment of psoriasis: three-year results from the UNCOVER-3 study [published online May 24, 2018]. J Am Acad Dermatol. doi:10.1016/j.jaad.2018.05.032.