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J Am Acad Dermatol. 2015 Sep;73(3):400-9. doi: 10.1016/j.jaad.2015.05.013. Epub 2015 Jun 17.

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

Author information

1
Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany. Electronic address: diamant.thaci@uksh.de.
2
Oregon Medical Research Center, Portland, Oregon.
3
Dermatologikum Hamburg and Georg-August-University Göttingen, Göttingen, Germany.
4
National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
5
Hospital 12 de Octubre, Av de Córdoba, Madrid, Spain.
6
Clinic of Dermatology, Tartu University Hospital, Department of Dermatology, University of Tartu, Tartu, Estonia.
7
Department of Dermatology, Ha'Emek Medical Center, Afula, Israel.
8
University of Frankfurt, Frankfurt, Germany.
9
Novartis Pharma AG, Basel, Switzerland.
10
Beijing Novartis Pharma Co. Ltd, Shanghai, China.

Abstract

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.

KEYWORDS:

90% or more improvement in baseline Psoriasis Area and Severity Index; clear or almost clear skin; clinical trial; head to head; plaque psoriasis; secukinumab; superiority; ustekinumab

PMID:
26092291
DOI:
10.1016/j.jaad.2015.05.013
[Indexed for MEDLINE]
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