• Kenneth B Gordon, Craig L Leonardi, Mark Lebwohl, Andrew Blauvelt, Gregory S Cameron, Daniel Braun, Janelle Erickson, and Michael Heffernan.
• Northwestern University, Feinberg School of Medicine, Chicago, Illinois. Electronic address: kenneth-gordon@northwestern.edu.
• J. Am. Acad. Dermatol. 2014 Dec 1;71(6):1176-82.

BackgroundPatients with moderate to severe plaque psoriasis demonstrated positive responses to ixekizumab, an anti-interleukin-17A monoclonal antibody, in a phase-II, randomized, placebo-controlled trial.ObjectiveWe sought to evaluate long-term efficacy and safety of ixekizumab.MethodsAfter receiving 10, 25, 75, or 150 mg of ixekizumab or placebo during randomized, placebo-controlled trial, patients with less than 75% improvement from baseline on the Psoriasis Area and Severity Index (PASI) score (PASI75) entered open-label extension (OLE); patients with PASI75 or higher entered a treatment-free period (weeks 20-32), then entered OLE after meeting response criteria. During OLE, patients received 120 mg of subcutaneous ixekizumab every 4 weeks.ResultsIn all, 120 patients entered OLE; 103 completed 52 weeks or more of treatment. Overall, 77% of patients achieved PASI75 at week 52 (nonresponder imputation). Patients who responded to treatment in the randomized, placebo-controlled trial maintained a high-level response by week 52 of OLE (PASI75 = 95%; 90% improvement from baseline on the PASI score = 94%; 100% improvement from baseline on the PASI score = 82%). Irrespective of dose in the randomized, placebo-controlled trial, each group had similar response rates at week 52 of OLE. The exposure-adjusted incidence rate for adverse events was 0.47 and for serious adverse events was 0.06 per patient-year during OLE.LimitationsNo control group, small sample sizes, and bias toward retention of patients with positive responses limit interpretation.ConclusionA high proportion of patients responded to ixekizumab therapy and maintained clinical responses over 1 year of treatment with no unexpected safety signals.Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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