Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial
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...
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| Veröffentlicht in: | Journal of the American Academy of Dermatology 2015-09, Vol.73 (3), p.400-409 |
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| creator | Thaçi, Diamant, MD Blauvelt, Andrew, MD, MBA Reich, Kristian, MD Tsai, Tsen-Fang, MD Vanaclocha, Francisco, MD Kingo, Külli, MD, PhD Ziv, Michael, MD, BSc Pinter, Andreas, MD Hugot, Sophie, MSc You, Ruquan, MSc Milutinovic, Marina, MD |
| description | 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. |
| doi_str_mv | 10.1016/j.jaad.2015.05.013 |
| format | Article |
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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.</description><identifier>ISSN: 0190-9622</identifier><identifier>EISSN: 1097-6787</identifier><identifier>DOI: 10.1016/j.jaad.2015.05.013</identifier><identifier>PMID: 26092291</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>90% or more improvement in baseline Psoriasis Area and Severity Index ; Adult ; Analysis of Variance ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - adverse effects ; clear or almost clear skin ; clinical trial ; Dermatology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Female ; Follow-Up Studies ; head to head ; Humans ; Injections, Subcutaneous ; Male ; Maximum Tolerated Dose ; Middle Aged ; plaque psoriasis ; Psoriasis - diagnosis ; Psoriasis - drug therapy ; Reference Values ; Risk Assessment ; secukinumab ; Severity of Illness Index ; superiority ; Treatment Outcome ; ustekinumab ; Ustekinumab - administration & dosage ; Ustekinumab - adverse effects</subject><ispartof>Journal of the American Academy of Dermatology, 2015-09, Vol.73 (3), p.400-409</ispartof><rights>American Academy of Dermatology, Inc.</rights><rights>2015 American Academy of Dermatology, Inc.</rights><rights>Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c525t-152437db93893caf47113c4c1afcfd2ff18af919fa798efc58f68c0166fd2b23</citedby><cites>FETCH-LOGICAL-c525t-152437db93893caf47113c4c1afcfd2ff18af919fa798efc58f68c0166fd2b23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jaad.2015.05.013$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26092291$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thaçi, Diamant, MD</creatorcontrib><creatorcontrib>Blauvelt, Andrew, MD, MBA</creatorcontrib><creatorcontrib>Reich, Kristian, MD</creatorcontrib><creatorcontrib>Tsai, Tsen-Fang, MD</creatorcontrib><creatorcontrib>Vanaclocha, Francisco, MD</creatorcontrib><creatorcontrib>Kingo, Külli, MD, PhD</creatorcontrib><creatorcontrib>Ziv, Michael, MD, BSc</creatorcontrib><creatorcontrib>Pinter, Andreas, MD</creatorcontrib><creatorcontrib>Hugot, Sophie, MSc</creatorcontrib><creatorcontrib>You, Ruquan, MSc</creatorcontrib><creatorcontrib>Milutinovic, Marina, MD</creatorcontrib><title>Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial</title><title>Journal of the American Academy of Dermatology</title><addtitle>J Am Acad Dermatol</addtitle><description>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.</description><subject>90% or more improvement in baseline Psoriasis Area and Severity Index</subject><subject>Adult</subject><subject>Analysis of Variance</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>clear or almost clear skin</subject><subject>clinical trial</subject><subject>Dermatology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>head to head</subject><subject>Humans</subject><subject>Injections, Subcutaneous</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Middle Aged</subject><subject>plaque psoriasis</subject><subject>Psoriasis - diagnosis</subject><subject>Psoriasis - drug therapy</subject><subject>Reference Values</subject><subject>Risk Assessment</subject><subject>secukinumab</subject><subject>Severity of Illness Index</subject><subject>superiority</subject><subject>Treatment Outcome</subject><subject>ustekinumab</subject><subject>Ustekinumab - administration & dosage</subject><subject>Ustekinumab - adverse effects</subject><issn>0190-9622</issn><issn>1097-6787</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9Uk2LFDEQDaK4s6t_wIPk6MEeU-npj4gsLMOuCgOCu_eQSVc0venOmOpeWX-Gv9g0s-7Bg1BQIfXeo-pVMfYKxBoE1O_6dW9Mt5YCqrXIAeUTtgKhmqJu2uYpWwlQolC1lCfslKgXQqhN2TxnJ7IWSkoFK_b7Gu1868d5MHvuidN8wORj4lPkM034WBq5DWiSH79xyp88uozd92gn4j_99J0PscNkJlyYhHeYkB-C-THnRDF5Q57e8-3u8uLrW254MmMXB_8LO27jOKUYQn5OGRdesGfOBMKXD_mM3Vxd3mw_FbsvHz9vL3aFrWQ1FVDJPEy3V2WrSmvcpgEo7caCcdZ10jlojVOgnGlUi85Wratbm32rc3UvyzP25ih7SDF3SZMePFkMwYwYZ9LQiGrT1AraDJVHqE2RKKHTh-QHk-41CL2sQvd6WYVeVqFFDigz6fWD_rwfsHuk_PU-Az4cAZiHvPOYNFmPo8XOp2yr7qL_v_75P3Qb_OitCbd4j9THOY3ZPg2apBb6ejmG5RagyoJt2ZR_AH9Zsgk</recordid><startdate>20150901</startdate><enddate>20150901</enddate><creator>Thaçi, Diamant, MD</creator><creator>Blauvelt, Andrew, MD, MBA</creator><creator>Reich, Kristian, MD</creator><creator>Tsai, Tsen-Fang, MD</creator><creator>Vanaclocha, Francisco, MD</creator><creator>Kingo, Külli, MD, PhD</creator><creator>Ziv, Michael, MD, BSc</creator><creator>Pinter, Andreas, MD</creator><creator>Hugot, Sophie, MSc</creator><creator>You, Ruquan, MSc</creator><creator>Milutinovic, Marina, MD</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20150901</creationdate><title>Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial</title><author>Thaçi, Diamant, MD ; Blauvelt, Andrew, MD, MBA ; Reich, Kristian, MD ; Tsai, Tsen-Fang, MD ; Vanaclocha, Francisco, MD ; Kingo, Külli, MD, PhD ; Ziv, Michael, MD, BSc ; Pinter, Andreas, MD ; Hugot, Sophie, MSc ; You, Ruquan, MSc ; Milutinovic, Marina, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c525t-152437db93893caf47113c4c1afcfd2ff18af919fa798efc58f68c0166fd2b23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>90% or more improvement in baseline Psoriasis Area and Severity Index</topic><topic>Adult</topic><topic>Analysis of Variance</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>clear or almost clear skin</topic><topic>clinical trial</topic><topic>Dermatology</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>head to head</topic><topic>Humans</topic><topic>Injections, Subcutaneous</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Middle Aged</topic><topic>plaque psoriasis</topic><topic>Psoriasis - diagnosis</topic><topic>Psoriasis - drug therapy</topic><topic>Reference Values</topic><topic>Risk Assessment</topic><topic>secukinumab</topic><topic>Severity of Illness Index</topic><topic>superiority</topic><topic>Treatment Outcome</topic><topic>ustekinumab</topic><topic>Ustekinumab - administration & dosage</topic><topic>Ustekinumab - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Thaçi, Diamant, MD</creatorcontrib><creatorcontrib>Blauvelt, Andrew, MD, MBA</creatorcontrib><creatorcontrib>Reich, Kristian, MD</creatorcontrib><creatorcontrib>Tsai, Tsen-Fang, MD</creatorcontrib><creatorcontrib>Vanaclocha, Francisco, MD</creatorcontrib><creatorcontrib>Kingo, Külli, MD, PhD</creatorcontrib><creatorcontrib>Ziv, Michael, MD, BSc</creatorcontrib><creatorcontrib>Pinter, Andreas, MD</creatorcontrib><creatorcontrib>Hugot, Sophie, MSc</creatorcontrib><creatorcontrib>You, Ruquan, MSc</creatorcontrib><creatorcontrib>Milutinovic, Marina, MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American Academy of Dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Thaçi, Diamant, MD</au><au>Blauvelt, Andrew, MD, MBA</au><au>Reich, Kristian, MD</au><au>Tsai, Tsen-Fang, MD</au><au>Vanaclocha, Francisco, MD</au><au>Kingo, Külli, MD, PhD</au><au>Ziv, Michael, MD, BSc</au><au>Pinter, Andreas, MD</au><au>Hugot, Sophie, MSc</au><au>You, Ruquan, MSc</au><au>Milutinovic, Marina, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial</atitle><jtitle>Journal of the American Academy of Dermatology</jtitle><addtitle>J Am Acad Dermatol</addtitle><date>2015-09-01</date><risdate>2015</risdate><volume>73</volume><issue>3</issue><spage>400</spage><epage>409</epage><pages>400-409</pages><issn>0190-9622</issn><eissn>1097-6787</eissn><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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26092291</pmid><doi>10.1016/j.jaad.2015.05.013</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | 90% or more improvement in baseline Psoriasis Area and Severity Index Adult Analysis of Variance Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects clear or almost clear skin clinical trial Dermatology Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Follow-Up Studies head to head Humans Injections, Subcutaneous Male Maximum Tolerated Dose Middle Aged plaque psoriasis Psoriasis - diagnosis Psoriasis - drug therapy Reference Values Risk Assessment secukinumab Severity of Illness Index superiority Treatment Outcome ustekinumab Ustekinumab - administration & dosage Ustekinumab - adverse effects |
| title | Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial |
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