Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial

Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has shown superior efficacy to etanercept with similar safety in moderate to severe plaque psoriasis (FIXTURE study). We sought to directly compare efficacy and safety of secukinumab versus ustekinumab. In this 52-week, double-blin...

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Vydáno v:	Journal of the American Academy of Dermatology Ročník 73; číslo 3; s. 400 - 409
Hlavní autoři:	Thaçi, Diamant, Blauvelt, Andrew, Reich, Kristian, Tsai, Tsen-Fang, Vanaclocha, Francisco, Kingo, Külli, Ziv, Michael, Pinter, Andreas, Hugot, Sophie, You, Ruquan, Milutinovic, Marina
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States Elsevier Inc 01.09.2015
Témata:	90% or more improvement in baseline Psoriasis Area and Severity Index Adult Analysis of Variance Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects clear or almost clear skin clinical trial Dermatology Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Follow-Up Studies head to head Humans Injections, Subcutaneous Male Maximum Tolerated Dose Middle Aged plaque psoriasis Psoriasis - diagnosis Psoriasis - drug therapy Reference Values Risk Assessment secukinumab Severity of Illness Index superiority Treatment Outcome ustekinumab Ustekinumab - administration & dosage Ustekinumab - adverse effects clinical trial DLQI PASI 90 IGA PASI IL superiority AE IGA mod 2011 MedDRA secukinumab PASI 75 clear or almost clear skin TNF head to head PASI 100 ustekinumab SAE plaque psoriasis HRQoL 90% or more improvement in baseline Psoriasis Area and Severity Index investigator global assessment 2011 modified version Psoriasis Area and Severity Index Medical Dictionary for Regulatory Activities serious adverse event 75% or more improvement from baseline Psoriasis Area and Severity Index score interleukin 100% improvement from baseline Psoriasis Area and Severity Index score adverse event health-related quality of life 90% or more improvement from baseline Psoriasis Area and Severity Index score investigator global assessment tumor necrosis factor Dermatology Life Quality Index
ISSN:	0190-9622, 1097-6787
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Shrnutí:	Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has shown superior efficacy to etanercept with similar safety in moderate to severe plaque psoriasis (FIXTURE study). We sought to directly compare efficacy and safety of secukinumab versus ustekinumab. In this 52-week, double-blind study (NCT02074982), 676 subjects were randomized 1:1 to subcutaneous injection of secukinumab 300 mg or ustekinumab per label. Primary end point was 90% or more improvement from baseline Psoriasis Area and Severity Index (PASI) score (PASI 90) at week 16. Secukinumab (79.0%) was superior to ustekinumab (57.6%) as assessed by PASI 90 response at week 16 (P < .0001). The 100% improvement from baseline PASI score at week 16 was also significantly greater with secukinumab (44.3%) than ustekinumab (28.4%) (P < .0001). The 75% or more improvement from baseline PASI score at week 4 was superior for secukinumab (50.0%) versus ustekinumab (20.6%) (P < .0001). Percentage of subjects with the Dermatology Life Quality Index score 0/1 (week 16) was significantly higher with secukinumab (71.9%) than ustekinumab (57.4%) (P < .0001). The safety profile of secukinumab was comparable with ustekinumab and consistent with pivotal phase III secukinumab studies. The study was not placebo-controlled and of short-term duration. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe psoriasis and improving health-related quality of life with a comparable safety profile over 16 weeks.
Bibliografie:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3
ISSN:	0190-9622 1097-6787
DOI:	10.1016/j.jaad.2015.05.013