Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study.
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.


CONCLUSIONS
There was no placebo arm.


CONCLUSIONS
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.
Oregon Medical Research Center, Portland, Oregon. Electronic address: ablauvelt@oregonmedicalresearch.com.
Andrew
A
Blauvelt
Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany.
Kristian
K
Reich
National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Tsen-Fang
TF
Tsai
University of Texas Health Science Center at Houston, Center for Clinical Studies, Houston, Texas.
Stephen
S
Tyring
Hospital Universitario 12 de Octubre, Madrid, Spain.
Francisco
F
Vanaclocha
Dermatology Clinic, Tartu University Hospital, Tartu, Estonia.
Külli
K
Kingo
Emek Medical Center, Afula, Israel.
Michael
M
Ziv
Goethe Universität Frankfurt am Main, Frankfurt, Germany.
Andreas
A
Pinter
McMaster University, Hamilton, Ontario, Canada.
Ronald
R
Vender
Novartis Pharma AG, Basel, Switzerland.
Sophie
S
Hugot
Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China.
Ruquan
R
You
Novartis Pharma AG, Basel, Switzerland.
Marina
M
Milutinovic
Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany.
Diamant
D
Thaçi
D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D000069549:Ustekinumab / Q000009:adverse effects / Q000627:therapeutic use*
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; C555450:secukinumab; D000069549:Ustekinumab
Psoriasis Area and Severity Index (PASI); clinical trial; efficacy; psoriasis; safety; secukinumab; ustekinumab