Andrew Blauvelt1, Kristian Reich2, Tsen-Fang Tsai3, Stephen Tyring4, Francisco Vanaclocha5, Külli Kingo6, Michael Ziv7, Andreas Pinter8, Ronald Vender9, Sophie Hugot10, Ruquan You11, Marina Milutinovic10, Diamant Thaçi12. 1. Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com. 2. Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany. 3. National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. 4. University of Texas Health Science Center at Houston, Center for Clinical Studies, Houston, Texas. 5. Hospital Universitario 12 de Octubre, Madrid, Spain. 6. Dermatology Clinic, Tartu University Hospital, Tartu, Estonia. 7. Emek Medical Center, Afula, Israel. 8. Goethe Universität Frankfurt am Main, Frankfurt, Germany. 9. McMaster University, Hamilton, Ontario, Canada. 10. Novartis Pharma AG, Basel, Switzerland. 11. Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China. 12. Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany.
Abstract
BACKGROUND:Secukinumab demonstrated superior efficacy to ustekinumab at week 4 and week 16 of the CLEAR study, with comparable safety, in subjects with moderate-to-severe plaque psoriasis. OBJECTIVE: To compare the efficacy and safety of secukinumab and ustekinumab use over 52 weeks. METHODS: Analysis of 52-week data from CLEAR, a randomized, double-blind, phase 3b study. RESULTS: Among 676 randomized subjects, secukinumab demonstrated superiority to ustekinumab at week 52 in the proportion of subjects with ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) (76% vs 61% [P < .0001]); PASI 100 responses were 46% versus 36% (P = .0103) and Investigator's Global Assessment responses of clear/almost clear skin were 80% versus 65% (P < .0001). Subjects on secukinumab reported greater reductions in psoriasis-related pain, itching, and scaling, and greater improvement across all quality-of-life measures evaluated (Dermatology Life Quality Index [DLQI], EuroQoL5-Dimension Health Questionnaire, Work Productivity and Activity Impairment Questionnaire-Psoriasis, and Health Assessment Questionnaire-Disability Index). At week 52, 72% of subjects on secukinumab versus 59% on ustekinumab (P = .0008) reported no impact of skin disease on their lives (DLQI 0/1 response). Safety and tolerability was comparable. LIMITATIONS: There was no placebo arm. CONCLUSION: In this head-to-head, double-blind study, secukinumab demonstrated sustained superior efficacy in comparison with ustekinumab in clearing skin through week 52, greater improvement in quality of life, and a favorable and comparable safety profile.
RCT Entities:
BACKGROUND:Secukinumab demonstrated superior efficacy to ustekinumab at week 4 and week 16 of the CLEAR study, with comparable safety, in subjects with moderate-to-severe plaque psoriasis. OBJECTIVE: To compare the efficacy and safety of secukinumab and ustekinumab use over 52 weeks. METHODS: Analysis of 52-week data from CLEAR, a randomized, double-blind, phase 3b study. RESULTS: Among 676 randomized subjects, secukinumab demonstrated superiority to ustekinumab at week 52 in the proportion of subjects with ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) (76% vs 61% [P < .0001]); PASI 100 responses were 46% versus 36% (P = .0103) and Investigator's Global Assessment responses of clear/almost clear skin were 80% versus 65% (P < .0001). Subjects on secukinumab reported greater reductions in psoriasis-related pain, itching, and scaling, and greater improvement across all quality-of-life measures evaluated (Dermatology Life Quality Index [DLQI], EuroQoL 5-Dimension Health Questionnaire, Work Productivity and Activity Impairment Questionnaire-Psoriasis, and Health Assessment Questionnaire-Disability Index). At week 52, 72% of subjects on secukinumab versus 59% on ustekinumab (P = .0008) reported no impact of skin disease on their lives (DLQI 0/1 response). Safety and tolerability was comparable. LIMITATIONS: There was no placebo arm. CONCLUSION: In this head-to-head, double-blind study, secukinumab demonstrated sustained superior efficacy in comparison with ustekinumab in clearing skin through week 52, greater improvement in quality of life, and a favorable and comparable safety profile.
Authors: Vineet S Rolston; Jessica Kimmel; Violeta Popov; Brian P Bosworth; David Hudesman; Lisa B Malter; Simon Hong; Shannon Chang Journal: Dig Dis Sci Date: 2020-05-22 Impact factor: 3.199
Authors: Xintong Li; Kathleen M Andersen; Hsien-Yen Chang; Jeffrey R Curtis; G Caleb Alexander Journal: Ann Rheum Dis Date: 2019-10-31 Impact factor: 19.103