Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial - 17/08/15
, Andrew Blauvelt, MD, MBA b, Kristian Reich, MD c, Tsen-Fang Tsai, MD d, Francisco Vanaclocha, MD e, Külli Kingo, MD, PhD f, Michael Ziv, MD, BSc g, Andreas Pinter, MD h, Sophie Hugot, MSc i, Ruquan You, MSc j, Marina Milutinovic, MD iAbstract |
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 numéro
Article précédent
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