TY  - JOUR
A1  - Thaçi, Diamant
A1  - Blauvelt, Andrew
A1  - Reichelt, Kristian
A1  - Tsai, Tsen-Fang
A1  - Vanaclocha, Francisco
A1  - Kingo, Külli
A1  - Ziv, Michael
A1  - Pinter, Andreas
A1  - Hugot, Sophie
A1  - You, Ruquan
A1  - Milutinovic, Marina
T1  - Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial
T2  - Journal of the American Academy of Dermatology
N2  - BACKGROUND: 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).
OBJECTIVE: We sought to directly compare efficacy and safety of secukinumab versus ustekinumab.
METHODS: 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.
RESULTS: 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.
LIMITATIONS: The study was not placebo-controlled and of short-term duration.
CONCLUSIONS: 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.
KW  - 90% or more improvement in baseline Psoriasis Area and Severity Index
KW  - clear or almost clear skin
KW  - clinical trial
KW  - head to head
KW  - plaque psoriasis
KW  - secukinumab
KW  - superiority
KW  - ustekinumab
Y1  - 2015
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/41814
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-418146
SN  - 0190-9622
N1  - (c) 2015 by the American Academy of Dermatology, Inc. Published by Elsevier, Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncn-d/4.0/).
VL  - 73
IS  - 3
SP  - 400
EP  - 409
ER  -