Craig Leonardi1, Catherine Maari2, Sandra Philipp3, Orin Goldblum4, Lu Zhang4, Nicole Burkhardt4, Susan Ball4, Lotus Mallbris4, Pablo Gonzalez5, Pablo Fernández-Peñas6, Luis Puig7. 1. Central Dermatology, St. Louis, Missouri. Electronic address: Craig.Leonardi@centralderm.com. 2. Innovaderm Research Inc, Montreal, Quebec, Canada; Medical University of Graz, Graz, Austria. 3. Charité Universitätsmedizin Berlin, Berlin, Germany. 4. Eli Lilly and Company, Indianapolis, Indiana. 5. Buenos Aires Skin SA, Buenos Aires, Argentina. 6. Department of Dermatology, Westmead Hospital Dermatology Service, The University of Sydney, Westmead, Australia. 7. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Abstract
BACKGROUND: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. OBJECTIVE: To 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 ofIXE at week 0, 80 mg every 2 weeks up to week 12, and 80 mg every 4 weeks thereafter). METHODS: Patients 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. RESULTS: 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. LIMITATIONS: No placebo or active comparison after week 12. CONCLUSION:IXE sustained high responses with clearance of skin and nail lesions, with no new safety concerns through 3 years.
RCT Entities:
BACKGROUND: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. OBJECTIVE: To 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). METHODS:Patients 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. RESULTS: 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. LIMITATIONS: No placebo or active comparison after week 12. CONCLUSION: IXE sustained high responses with clearance of skin and nail lesions, with no new safety concerns through 3 years.
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Authors: Craig Leonardi; Kristian Reich; Peter Foley; Hideshi Torii; Sascha Gerdes; Lyn Guenther; Melinda Gooderham; Laura K Ferris; Christopher E M Griffiths; Hany ElMaraghy; Heidi Crane; Himanshu Patel; Russel Burge; Gaia Gallo; David Shrom; Ann Leung; Chen-Yen Lin; Kim Papp Journal: Dermatol Ther (Heidelb) Date: 2020-03-21