Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial - 17/08/15
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.
Le texte complet de cet article est disponible en PDF.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, DLQI, HRQoL, IGA, IGA mod 2011, IL, MedDRA, PASI, PASI 75, PASI 90, PASI 100, SAE, TNF
Plan
Novartis Pharma AG (Basel, Switzerland) supported this study. |
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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. |
Vol 73 - N° 3
P. 400-409 - septembre 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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