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

2018; Elsevier BV; Volume: 79; Issue: 5 Linguagem: Inglês

10.1016/j.jaad.2018.05.032

1097-6787

Craig L. Leonardi, Catherine Maari, Sandra Philipp, Orin M. Goldblum, Lu Zhang, Nicole Y. Burkhardt, Susan Ball, Lotus Mallbris, Pablo Gonzalez, Pablo Fernández‐Peñas, L. Puig,

Antifungal resistance and susceptibility

BackgroundPsoriasis 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.ObjectiveTo evaluate the efficacy and safety of IXE through 156 weeks from the UNCOVER-3 study in patients who were treated with the recommended dose regimen (160 mg of IXE at week 0, 80 mg every 2 weeks up to week 12, and 80 mg every 4 weeks thereafter).MethodsPatients randomized to IXE every 2 weeks, IXE every 4 weeks, etanercept twice weekly, or placebo were switched to IXE every 4 weeks during the long-term extension period. Efficacy data were summarized by using the as-observed, multiple imputation, and modified nonresponder imputation methods.ResultsAt 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.LimitationsNo placebo or active comparison after week 12.ConclusionIXE sustained high responses with clearance of skin and nail lesions, with no new safety concerns through 3 years.