Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial

Background User satisfaction is an important factor associated with treatment adherence in chronic diseases including moderate‐to‐severe psoriasis. Objective To evaluate the efficacy, safety and patient acceptability of 300 and 150 mg secukinumab – a fully human anti‐interleukin‐17A monoclonal antib...

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Veröffentlicht in:Journal of the European Academy of Dermatology and Venereology 2017-05, Vol.31 (5), p.847-856
Hauptverfasser: Lacour, J.‐P., Paul, C., Jazayeri, S., Papanastasiou, P., Xu, C., Nyirady, J., Fox, T., Papavassilis, C.
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container_end_page 856
container_issue 5
container_start_page 847
container_title Journal of the European Academy of Dermatology and Venereology
container_volume 31
creator Lacour, J.‐P.
Paul, C.
Jazayeri, S.
Papanastasiou, P.
Xu, C.
Nyirady, J.
Fox, T.
Papavassilis, C.
description Background User satisfaction is an important factor associated with treatment adherence in chronic diseases including moderate‐to‐severe psoriasis. Objective To evaluate the efficacy, safety and patient acceptability of 300 and 150 mg secukinumab – a fully human anti‐interleukin‐17A monoclonal antibody that has demonstrated efficacy in the treatment of patients with moderate‐to‐severe plaque psoriasis – self‐administered by autoinjection. Methods Patients with moderate‐to‐severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg or placebo self‐administered by autoinjection at baseline, Weeks 1, 2 and 3 and then every 4 weeks from Week 4 to Week 48. Efficacy responses [≥75/90/100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100) and clear/almost clear skin by Investigator's Global Assessment 2011 modified version (IGA mod 2011 0/1)] were measured at Week 52. Patient‐reported usability of the autoinjector was evaluated by the self‐injection assessment questionnaire to Week 48. Results At Week 52 with secukinumab 300 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 81.4/64.1/38.8% and 69.6% of patients, respectively, by multiple imputation. At Week 52 with secukinumab 150 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 75.2/57.4/33.1% and 60.2% of patients, respectively, by multiple imputation. Patient‐assessed acceptability of the autoinjector remained high to Week 48. The proportion of patients experiencing adverse events was greater with secukinumab 300 mg (88.6%) than with secukinumab 150 mg (78.7%). Conclusion Self‐administration of secukinumab using an autoinjector was associated with robust and sustained efficacy, a good safety profile and high acceptability.
doi_str_mv 10.1111/jdv.14073
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Objective To evaluate the efficacy, safety and patient acceptability of 300 and 150 mg secukinumab – a fully human anti‐interleukin‐17A monoclonal antibody that has demonstrated efficacy in the treatment of patients with moderate‐to‐severe plaque psoriasis – self‐administered by autoinjection. Methods Patients with moderate‐to‐severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg or placebo self‐administered by autoinjection at baseline, Weeks 1, 2 and 3 and then every 4 weeks from Week 4 to Week 48. Efficacy responses [≥75/90/100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100) and clear/almost clear skin by Investigator's Global Assessment 2011 modified version (IGA mod 2011 0/1)] were measured at Week 52. Patient‐reported usability of the autoinjector was evaluated by the self‐injection assessment questionnaire to Week 48. Results At Week 52 with secukinumab 300 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 81.4/64.1/38.8% and 69.6% of patients, respectively, by multiple imputation. At Week 52 with secukinumab 150 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 75.2/57.4/33.1% and 60.2% of patients, respectively, by multiple imputation. Patient‐assessed acceptability of the autoinjector remained high to Week 48. The proportion of patients experiencing adverse events was greater with secukinumab 300 mg (88.6%) than with secukinumab 150 mg (78.7%). Conclusion Self‐administration of secukinumab using an autoinjector was associated with robust and sustained efficacy, a good safety profile and high acceptability.</description><identifier>ISSN: 0926-9959</identifier><identifier>EISSN: 1468-3083</identifier><identifier>DOI: 10.1111/jdv.14073</identifier><identifier>PMID: 28111801</identifier><language>eng</language><publisher>England</publisher><subject>Antibodies, Monoclonal - administration &amp; dosage ; Double-Blind Method ; Humans ; Placebos ; Psoriasis - drug therapy ; Psoriasis - pathology ; Self Administration ; Severity of Illness Index ; Treatment Outcome</subject><ispartof>Journal of the European Academy of Dermatology and Venereology, 2017-05, Vol.31 (5), p.847-856</ispartof><rights>2017 European Academy of Dermatology and Venereology</rights><rights>2017 European Academy of Dermatology and Venereology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3253-13248b6e81b92e73f10d174779c4c41453f8c15c4f4b34e5c513eebe5c2b49f03</citedby><cites>FETCH-LOGICAL-c3253-13248b6e81b92e73f10d174779c4c41453f8c15c4f4b34e5c513eebe5c2b49f03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjdv.14073$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjdv.14073$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28111801$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lacour, J.‐P.</creatorcontrib><creatorcontrib>Paul, C.</creatorcontrib><creatorcontrib>Jazayeri, S.</creatorcontrib><creatorcontrib>Papanastasiou, P.</creatorcontrib><creatorcontrib>Xu, C.</creatorcontrib><creatorcontrib>Nyirady, J.</creatorcontrib><creatorcontrib>Fox, T.</creatorcontrib><creatorcontrib>Papavassilis, C.</creatorcontrib><title>Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial</title><title>Journal of the European Academy of Dermatology and Venereology</title><addtitle>J Eur Acad Dermatol Venereol</addtitle><description>Background User satisfaction is an important factor associated with treatment adherence in chronic diseases including moderate‐to‐severe psoriasis. Objective To evaluate the efficacy, safety and patient acceptability of 300 and 150 mg secukinumab – a fully human anti‐interleukin‐17A monoclonal antibody that has demonstrated efficacy in the treatment of patients with moderate‐to‐severe plaque psoriasis – self‐administered by autoinjection. Methods Patients with moderate‐to‐severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg or placebo self‐administered by autoinjection at baseline, Weeks 1, 2 and 3 and then every 4 weeks from Week 4 to Week 48. Efficacy responses [≥75/90/100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100) and clear/almost clear skin by Investigator's Global Assessment 2011 modified version (IGA mod 2011 0/1)] were measured at Week 52. Patient‐reported usability of the autoinjector was evaluated by the self‐injection assessment questionnaire to Week 48. Results At Week 52 with secukinumab 300 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 81.4/64.1/38.8% and 69.6% of patients, respectively, by multiple imputation. At Week 52 with secukinumab 150 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 75.2/57.4/33.1% and 60.2% of patients, respectively, by multiple imputation. Patient‐assessed acceptability of the autoinjector remained high to Week 48. The proportion of patients experiencing adverse events was greater with secukinumab 300 mg (88.6%) than with secukinumab 150 mg (78.7%). Conclusion Self‐administration of secukinumab using an autoinjector was associated with robust and sustained efficacy, a good safety profile and high acceptability.</description><subject>Antibodies, Monoclonal - administration &amp; dosage</subject><subject>Double-Blind Method</subject><subject>Humans</subject><subject>Placebos</subject><subject>Psoriasis - drug therapy</subject><subject>Psoriasis - pathology</subject><subject>Self Administration</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><issn>0926-9959</issn><issn>1468-3083</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1u1DAURi1ERYfCghdAXsIirX8nDjs0FGhVFQk6bCPHuRGeOvHU12k1PAzPitsp7GrJundxviPZHyFvODvm5Zxs-ttjrlgtn5EFV0tTSWbkc7JgjVhWTaObQ_ISccMY41ybF-RQmBIzjC_Inx_g5ms_zaPtqO1HP3nMyWYfJ9rtqJ1z9NMGXI6JjtZPuVykCfrZPTBxoNtgb2agW4zJW_RIEW4h-byjsUyqBb0DuMYPJYVzyHifyb-AJjv1cfS_oacuTjnFEMp6vr5cXa2_n9JcbOEVORhsQHj9OI_I-vPp1eprdfHty9nq40XlpNCy4lIo0y3B8K4RUMuBs57Xqq4bp5ziSsvBOK6dGlQnFWinuQToyiI61QxMHpF3e-82xfIYzO3o0UEIdoI4Y8vNkutG1kIU9P0edSkiJhjabfKjTbuWs_a-jrbU0T7UUdi3j9q5G6H_T_77_wKc7IE7H2D3tKk9__Rzr_wLHC-XUw</recordid><startdate>201705</startdate><enddate>201705</enddate><creator>Lacour, J.‐P.</creator><creator>Paul, C.</creator><creator>Jazayeri, S.</creator><creator>Papanastasiou, P.</creator><creator>Xu, C.</creator><creator>Nyirady, J.</creator><creator>Fox, T.</creator><creator>Papavassilis, C.</creator><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>201705</creationdate><title>Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial</title><author>Lacour, J.‐P. ; Paul, C. ; Jazayeri, S. ; Papanastasiou, P. ; Xu, C. ; Nyirady, J. ; Fox, T. ; Papavassilis, C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3253-13248b6e81b92e73f10d174779c4c41453f8c15c4f4b34e5c513eebe5c2b49f03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Antibodies, Monoclonal - administration &amp; dosage</topic><topic>Double-Blind Method</topic><topic>Humans</topic><topic>Placebos</topic><topic>Psoriasis - drug therapy</topic><topic>Psoriasis - pathology</topic><topic>Self Administration</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lacour, J.‐P.</creatorcontrib><creatorcontrib>Paul, C.</creatorcontrib><creatorcontrib>Jazayeri, S.</creatorcontrib><creatorcontrib>Papanastasiou, P.</creatorcontrib><creatorcontrib>Xu, C.</creatorcontrib><creatorcontrib>Nyirady, J.</creatorcontrib><creatorcontrib>Fox, T.</creatorcontrib><creatorcontrib>Papavassilis, C.</creatorcontrib><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 European Academy of Dermatology and Venereology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lacour, J.‐P.</au><au>Paul, C.</au><au>Jazayeri, S.</au><au>Papanastasiou, P.</au><au>Xu, C.</au><au>Nyirady, J.</au><au>Fox, T.</au><au>Papavassilis, C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial</atitle><jtitle>Journal of the European Academy of Dermatology and Venereology</jtitle><addtitle>J Eur Acad Dermatol Venereol</addtitle><date>2017-05</date><risdate>2017</risdate><volume>31</volume><issue>5</issue><spage>847</spage><epage>856</epage><pages>847-856</pages><issn>0926-9959</issn><eissn>1468-3083</eissn><abstract>Background User satisfaction is an important factor associated with treatment adherence in chronic diseases including moderate‐to‐severe psoriasis. Objective To evaluate the efficacy, safety and patient acceptability of 300 and 150 mg secukinumab – a fully human anti‐interleukin‐17A monoclonal antibody that has demonstrated efficacy in the treatment of patients with moderate‐to‐severe plaque psoriasis – self‐administered by autoinjection. Methods Patients with moderate‐to‐severe plaque psoriasis were randomized to secukinumab 300 mg, secukinumab 150 mg or placebo self‐administered by autoinjection at baseline, Weeks 1, 2 and 3 and then every 4 weeks from Week 4 to Week 48. Efficacy responses [≥75/90/100% improvement in Psoriasis Area and Severity Index (PASI 75/90/100) and clear/almost clear skin by Investigator's Global Assessment 2011 modified version (IGA mod 2011 0/1)] were measured at Week 52. Patient‐reported usability of the autoinjector was evaluated by the self‐injection assessment questionnaire to Week 48. Results At Week 52 with secukinumab 300 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 81.4/64.1/38.8% and 69.6% of patients, respectively, by multiple imputation. At Week 52 with secukinumab 150 mg, PASI 75/90/100 and IGA mod 2011 0/1 responses were achieved by 75.2/57.4/33.1% and 60.2% of patients, respectively, by multiple imputation. Patient‐assessed acceptability of the autoinjector remained high to Week 48. The proportion of patients experiencing adverse events was greater with secukinumab 300 mg (88.6%) than with secukinumab 150 mg (78.7%). Conclusion Self‐administration of secukinumab using an autoinjector was associated with robust and sustained efficacy, a good safety profile and high acceptability.</abstract><cop>England</cop><pmid>28111801</pmid><doi>10.1111/jdv.14073</doi><tpages>10</tpages></addata></record>
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subjects Antibodies, Monoclonal - administration & dosage
Double-Blind Method
Humans
Placebos
Psoriasis - drug therapy
Psoriasis - pathology
Self Administration
Severity of Illness Index
Treatment Outcome
title Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial
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