Efficacy and Safety of Ixekizumab Over 4 Years of Open-Label Treatment in a Phase 2 Study in Chronic Plaque Psoriasis

Publication date: Available online 10 April 2018
Source:Journal of the American Academy of Dermatology
Author(s): Claus Zachariae, Kenneth Gordon, Alexandra Kimball, Mark Lebwohl, Andrew Blauvelt, Craig Leonardi, Daniel Braun, Missy McKean-Matthews, Russel Burge, Gregory Cameron
BackgroundIxekizumab has demonstrated improvement in moderate-to-severe psoriasis patients by selectively targeting interleukin-17A, a pro-inflammatory cytokine important in psoriasis pathogenesis.ObjectiveTo report 4-year efficacy and safety results from the open-label extension (OLE) of this phase 2 trial.MethodsAnalysis was by last observation carried forward. Patients received ixekizumab 120 mg then 80 mg subcutaneously once every 4 weeks.ResultsNinety-three percent of patients who completed the randomized placebo-controlled trial entered the OLE. A 75% reduction on the Psoriasis Area Severity Index was reported in 82% of patients at OLE Week 208. A static Physician's Global Assessment score of 0 or1 was reported in 64% and a score of 0 was reported in 45% at Week 208. Dermatology Life Quality Index and Itch Visual Analog Scale scores decreased when compared to baseline. Improvements were observed in other efficacy and health outcome measures. Serious adverse events were observed in 16.7% of patients, and 87% had ≥1 treatment-emergent adverse event. Three patients had serious infections. One patient reported 2 major cardiovascular events.LimitationsThe study was unblinded and lacked a placebo or active comparator.ConclusionsEfficacy was shown to be maintained for up to 4 years of ixekizumab treatment.

Teaser

Interleukin-17A is a critical cytokine involved in psoriasis pathogenesis., The efficacy of ixekizumab, an interleukin-17A monoclonal antibody, was maintained for up to 4 years without apparent increases in health risks or safety issues in moderate-to-severe psoriasis patients., Long-term ixekizumab treatment is an option for moderate-to-severe psoriasis patients.