Diamant Thaçi, Andrew Blauvelt, Kristian Reichelt, Tsen-Fang Tsai, Francisco Vanaclocha, Külli Kingo, Michael Ziv, Andreas Pinter, Sophie Hugot, Ruquan You, Marina Milutinovic
- 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.
MetadatenVerfasserangaben: | Diamant ThaçiORCiD, Andrew Blauvelt, Kristian Reichelt, Tsen-Fang Tsai, Francisco Vanaclocha, Külli Kingo, Michael Ziv, Andreas PinterORCiDGND, Sophie Hugot, Ruquan You, Marina Milutinovic |
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URN: | urn:nbn:de:hebis:30:3-418146 |
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DOI: | https://doi.org/10.1016/j.jaad.2015.05.013 |
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ISSN: | 0190-9622 |
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Pubmed-Id: | https://pubmed.ncbi.nlm.nih.gov/26092291 |
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Titel des übergeordneten Werkes (Englisch): | Journal of the American Academy of Dermatology |
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Dokumentart: | Wissenschaftlicher Artikel |
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Sprache: | Englisch |
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Jahr der Fertigstellung: | 2015 |
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Datum der Erstveröffentlichung: | 06.06.2015 |
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Veröffentlichende Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Datum der Freischaltung: | 28.10.2016 |
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Freies Schlagwort / Tag: | 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 |
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Jahrgang: | 73 |
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Ausgabe / Heft: | 3 |
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Seitenzahl: | 10 |
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Erste Seite: | 400 |
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Letzte Seite: | 409 |
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Bemerkung: | (c) 2015 by the American Academy of Dermatology, Inc. Published by Elsevier, Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-ncn-d/4.0/). |
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HeBIS-PPN: | 423733656 |
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Institute: | Medizin / Medizin |
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DDC-Klassifikation: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Lizenz (Deutsch): | Creative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0 |
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