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

https://doi.org/10.1016/j.jaad.2015.05.013Get rights and content
Under a Creative Commons license
open access

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.

Key words

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

Abbreviations used

AE
adverse event
DLQI
Dermatology Life Quality Index
HRQoL
health-related quality of life
IGA
investigator global assessment
IGA mod 2011
investigator global assessment 2011 modified version
IL
interleukin
MedDRA
Medical Dictionary for Regulatory Activities
PASI
Psoriasis Area and Severity Index
PASI 75
75% or more improvement from baseline Psoriasis Area and Severity Index score
PASI 90
90% or more improvement from baseline Psoriasis Area and Severity Index score
PASI 100
100% improvement from baseline Psoriasis Area and Severity Index score
SAE
serious adverse event
TNF
tumor necrosis factor

Cited by (0)

Novartis Pharma AG (Basel, Switzerland) supported this study.

Disclosure: Dr Thaçi has served as a consultant, served as an advisory board member, and/or received honoraria for lecturing for AbbVie, Amgen, Biogen-Idec, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, MSD, Novartis, Pfizer, Regeneron, and Sanofi. Dr Blauvelt has served as a scientific consultant and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Ortho Biotech, Merck, Novartis, Pfizer, and Sandoz. Dr Reich has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Eli Lilly, Forward Pharma, GSK, Janssen-Cilag, Leo Pharma, Medac, MSD, Novartis, Pfizer, Vertex, Takeda, and Xenoport. Dr Tsai has served as consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, Galderma, Novartis, and Pfizer. Dr Kingo has served as a principal investigator in clinical studies sponsored by Celgene, Mitsubishi Pharma Corporation, Novartis, and Sandoz. Dr Pinter has served as a clinical study investigator and/or scientific consultant and/or paid speaker for AbbVie, Amgen, Biogen-Idec, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen-Cilag, Leo Pharma, Merck, Novartis, Pfizer, and Regeneron. Dr Ziv has served as a paid speaker/consultant/clinical trials investigator for AbbVie, Coherus Biosciences, Janssen-Cilag, Novartis, and Pfizer. Dr Vanaclocha has served as a principal investigator in clinical studies sponsored by Celgene, Janssen, Merck, and Novartis. Ms Hugot, Mr You, and Dr Milutinovic are employees of and/or own stock in Novartis.