A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis
Summary Background Nail psoriasis is common in patients with psoriasis and can seriously affect their quality of life. Current treatments are limited and there is no standard course of therapy. Objectives To assess the efficacy and safety of etanercept (ETN) on nail psoriasis in patients with mode...
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| Veröffentlicht in: | British journal of dermatology (1951) 2013-05, Vol.168 (5), p.1080-1087 |
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| container_title | British journal of dermatology (1951) |
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| creator | Ortonne, J.P. Paul, C. Berardesca, E. Marino, V. Gallo, G. Brault, Y. Germain, J.M. |
| description | Summary
Background Nail psoriasis is common in patients with psoriasis and can seriously affect their quality of life. Current treatments are limited and there is no standard course of therapy.
Objectives To assess the efficacy and safety of etanercept (ETN) on nail psoriasis in patients with moderate‐to‐severe psoriasis.
Methods Patients with moderate‐to‐severe plaque psoriasis, who had previously failed at least one form of systemic therapy for nail psoriasis, were randomized to receive open‐label ETN 50 mg twice weekly (BIW) for 12 weeks followed by once weekly (QW) for 12 weeks (BIW/QW group) or ETN 50 mg QW for 24 weeks (QW/QW group). The primary endpoint was the mean improvement in the Nail Psoriasis Severity Index (NAPSI; score range 0–8) over 24 weeks in the target fingernail with the most severe abnormalities.
Results Seventy‐two patients received one or more doses of ETN (38 BIW/QW; 34 QW/QW) and 69 patients were included in the modified intent‐to‐treat population. At baseline, mean (standard error) target fingernail NAPSI score was 6·0 (0·3) in the BIW/QW group and 5·8 (0·3) in the QW/QW group. At week 24, mean target fingernail NAPSI score had decreased significantly by −4·3 [95% confidence interval (CI) −4·9 to −3·7; P |
| doi_str_mv | 10.1111/bjd.12060 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_1346582125</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1346582125</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3590-a79db4692db796519bb686d2a4d0cd54aacb30e1ea8c33f7b90f5a6f8f726f8d3</originalsourceid><addsrcrecordid>eNpFkU1THCEQhqlUUrpRD_6BFJdUeRltYICdo9Fkk5TGQ768UQw0Bp2dWQfWzebXB92N4dA01c_7VtNNyCGDY1bOSXvrjxkHBS_IhAklK86EeEkmAKAraJTYJa9TugVgAiTskF0uSspBT8jDKeV1tUK8o6Pt_TCPf9BT18U-OtvRPMYSY_-AKccbm2N_Q_MvpBhCqbs1LRqabMC8pkOgeTVQPyRMjw_MtsfR4SIXA9rb2NFFGophimmfvAq2S3iwvffI9w_vv519rC6uZp_OTi8qJ2QDldWNb2vVcN_qRknWtK2aKs9t7cF5WVvrWgHI0E6dEEG3DQRpVZgGzUv0Yo8cbXwX43C_LJ8w85gcdl1pbVgmw0St5JQzLgv6Zosu2zl6sxjj3I5r829WBXi7BWwqswllXi6m_5wWstYgCney4Vaxw_VznYF5XJYpyzJPyzLvPp8_JUVRbRQxZfz9rLDjnVFaaGl-fpmZyx9fzy_l7NqA-Avnk5YN</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1346582125</pqid></control><display><type>article</type><title>A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Oxford University Press Journals All Titles (1996-Current)</source><creator>Ortonne, J.P. ; Paul, C. ; Berardesca, E. ; Marino, V. ; Gallo, G. ; Brault, Y. ; Germain, J.M.</creator><creatorcontrib>Ortonne, J.P. ; Paul, C. ; Berardesca, E. ; Marino, V. ; Gallo, G. ; Brault, Y. ; Germain, J.M.</creatorcontrib><description>Summary
Background Nail psoriasis is common in patients with psoriasis and can seriously affect their quality of life. Current treatments are limited and there is no standard course of therapy.
Objectives To assess the efficacy and safety of etanercept (ETN) on nail psoriasis in patients with moderate‐to‐severe psoriasis.
Methods Patients with moderate‐to‐severe plaque psoriasis, who had previously failed at least one form of systemic therapy for nail psoriasis, were randomized to receive open‐label ETN 50 mg twice weekly (BIW) for 12 weeks followed by once weekly (QW) for 12 weeks (BIW/QW group) or ETN 50 mg QW for 24 weeks (QW/QW group). The primary endpoint was the mean improvement in the Nail Psoriasis Severity Index (NAPSI; score range 0–8) over 24 weeks in the target fingernail with the most severe abnormalities.
Results Seventy‐two patients received one or more doses of ETN (38 BIW/QW; 34 QW/QW) and 69 patients were included in the modified intent‐to‐treat population. At baseline, mean (standard error) target fingernail NAPSI score was 6·0 (0·3) in the BIW/QW group and 5·8 (0·3) in the QW/QW group. At week 24, mean target fingernail NAPSI score had decreased significantly by −4·3 [95% confidence interval (CI) −4·9 to −3·7; P < 0·0001] in the BIW/QW group and by −4·4 (95% CI −5·0 to −3·7; P < 0·0001) in the QW/QW group. Improvement in NAPSI showed significant correlation with Psoriasis Area and Severity Index improvement. ETN was well tolerated with no unexpected safety findings.
Conclusions Both ETN regimens were effective at treating nail psoriasis in this patient population.
What’s already known about this topic?
•
Nail psoriasis can be painful and severely debilitating.
•
Current treatments of nail psoriasis are limited.
•
Very few studies have specifically investigated the efficacy and safety of systemic antipsoriatic agents in nail psoriasis.
What does this study add?
•
This is the first randomized study specifically designed to investigate the effects of etanercept on nail psoriasis in patients with moderate‐to‐severe psoriasis.
•
The results of this study show nail psoriasis can be treated effectively with both treatment regimens of 50 mg etanercept twice weekly for 12 weeks followed by once weekly for 12 weeks and 50 mg etanercept once weekly for 24 weeks.</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/bjd.12060</identifier><identifier>PMID: 23013207</identifier><identifier>CODEN: BJDEAZ</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Biological and medical sciences ; Dermatology ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Etanercept ; Female ; Humans ; Immunoglobulin G - administration & dosage ; Immunoglobulin G - adverse effects ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - adverse effects ; Male ; Medical sciences ; Middle Aged ; Nail Diseases - drug therapy ; Nails ; Psoriasis - drug therapy ; Psoriasis. Parapsoriasis. Lichen ; Receptors, Tumor Necrosis Factor - administration & dosage ; Severity of Illness Index ; Time Factors ; Treatment Outcome ; Tumor Necrosis Factor-alpha - antagonists & inhibitors</subject><ispartof>British journal of dermatology (1951), 2013-05, Vol.168 (5), p.1080-1087</ispartof><rights>2013 The Authors. BJD © 2013 British Association of Dermatologists</rights><rights>2014 INIST-CNRS</rights><rights>2013 The Authors. BJD © 2013 British Association of Dermatologists.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3590-a79db4692db796519bb686d2a4d0cd54aacb30e1ea8c33f7b90f5a6f8f726f8d3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjd.12060$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjd.12060$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,777,781,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27354703$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23013207$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ortonne, J.P.</creatorcontrib><creatorcontrib>Paul, C.</creatorcontrib><creatorcontrib>Berardesca, E.</creatorcontrib><creatorcontrib>Marino, V.</creatorcontrib><creatorcontrib>Gallo, G.</creatorcontrib><creatorcontrib>Brault, Y.</creatorcontrib><creatorcontrib>Germain, J.M.</creatorcontrib><title>A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background Nail psoriasis is common in patients with psoriasis and can seriously affect their quality of life. Current treatments are limited and there is no standard course of therapy.
Objectives To assess the efficacy and safety of etanercept (ETN) on nail psoriasis in patients with moderate‐to‐severe psoriasis.
Methods Patients with moderate‐to‐severe plaque psoriasis, who had previously failed at least one form of systemic therapy for nail psoriasis, were randomized to receive open‐label ETN 50 mg twice weekly (BIW) for 12 weeks followed by once weekly (QW) for 12 weeks (BIW/QW group) or ETN 50 mg QW for 24 weeks (QW/QW group). The primary endpoint was the mean improvement in the Nail Psoriasis Severity Index (NAPSI; score range 0–8) over 24 weeks in the target fingernail with the most severe abnormalities.
Results Seventy‐two patients received one or more doses of ETN (38 BIW/QW; 34 QW/QW) and 69 patients were included in the modified intent‐to‐treat population. At baseline, mean (standard error) target fingernail NAPSI score was 6·0 (0·3) in the BIW/QW group and 5·8 (0·3) in the QW/QW group. At week 24, mean target fingernail NAPSI score had decreased significantly by −4·3 [95% confidence interval (CI) −4·9 to −3·7; P < 0·0001] in the BIW/QW group and by −4·4 (95% CI −5·0 to −3·7; P < 0·0001) in the QW/QW group. Improvement in NAPSI showed significant correlation with Psoriasis Area and Severity Index improvement. ETN was well tolerated with no unexpected safety findings.
Conclusions Both ETN regimens were effective at treating nail psoriasis in this patient population.
What’s already known about this topic?
•
Nail psoriasis can be painful and severely debilitating.
•
Current treatments of nail psoriasis are limited.
•
Very few studies have specifically investigated the efficacy and safety of systemic antipsoriatic agents in nail psoriasis.
What does this study add?
•
This is the first randomized study specifically designed to investigate the effects of etanercept on nail psoriasis in patients with moderate‐to‐severe psoriasis.
•
The results of this study show nail psoriasis can be treated effectively with both treatment regimens of 50 mg etanercept twice weekly for 12 weeks followed by once weekly for 12 weeks and 50 mg etanercept once weekly for 24 weeks.</description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Dermatology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Etanercept</subject><subject>Female</subject><subject>Humans</subject><subject>Immunoglobulin G - administration & dosage</subject><subject>Immunoglobulin G - adverse effects</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nail Diseases - drug therapy</subject><subject>Nails</subject><subject>Psoriasis - drug therapy</subject><subject>Psoriasis. Parapsoriasis. Lichen</subject><subject>Receptors, Tumor Necrosis Factor - administration & dosage</subject><subject>Severity of Illness Index</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Tumor Necrosis Factor-alpha - antagonists & inhibitors</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkU1THCEQhqlUUrpRD_6BFJdUeRltYICdo9Fkk5TGQ768UQw0Bp2dWQfWzebXB92N4dA01c_7VtNNyCGDY1bOSXvrjxkHBS_IhAklK86EeEkmAKAraJTYJa9TugVgAiTskF0uSspBT8jDKeV1tUK8o6Pt_TCPf9BT18U-OtvRPMYSY_-AKccbm2N_Q_MvpBhCqbs1LRqabMC8pkOgeTVQPyRMjw_MtsfR4SIXA9rb2NFFGophimmfvAq2S3iwvffI9w_vv519rC6uZp_OTi8qJ2QDldWNb2vVcN_qRknWtK2aKs9t7cF5WVvrWgHI0E6dEEG3DQRpVZgGzUv0Yo8cbXwX43C_LJ8w85gcdl1pbVgmw0St5JQzLgv6Zosu2zl6sxjj3I5r829WBXi7BWwqswllXi6m_5wWstYgCney4Vaxw_VznYF5XJYpyzJPyzLvPp8_JUVRbRQxZfz9rLDjnVFaaGl-fpmZyx9fzy_l7NqA-Avnk5YN</recordid><startdate>201305</startdate><enddate>201305</enddate><creator>Ortonne, J.P.</creator><creator>Paul, C.</creator><creator>Berardesca, E.</creator><creator>Marino, V.</creator><creator>Gallo, G.</creator><creator>Brault, Y.</creator><creator>Germain, J.M.</creator><general>Blackwell Publishing Ltd</general><general>Wiley-Blackwell</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201305</creationdate><title>A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis</title><author>Ortonne, J.P. ; Paul, C. ; Berardesca, E. ; Marino, V. ; Gallo, G. ; Brault, Y. ; Germain, J.M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3590-a79db4692db796519bb686d2a4d0cd54aacb30e1ea8c33f7b90f5a6f8f726f8d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Dermatology</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Etanercept</topic><topic>Female</topic><topic>Humans</topic><topic>Immunoglobulin G - administration & dosage</topic><topic>Immunoglobulin G - adverse effects</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nail Diseases - drug therapy</topic><topic>Nails</topic><topic>Psoriasis - drug therapy</topic><topic>Psoriasis. Parapsoriasis. Lichen</topic><topic>Receptors, Tumor Necrosis Factor - administration & dosage</topic><topic>Severity of Illness Index</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Tumor Necrosis Factor-alpha - antagonists & inhibitors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ortonne, J.P.</creatorcontrib><creatorcontrib>Paul, C.</creatorcontrib><creatorcontrib>Berardesca, E.</creatorcontrib><creatorcontrib>Marino, V.</creatorcontrib><creatorcontrib>Gallo, G.</creatorcontrib><creatorcontrib>Brault, Y.</creatorcontrib><creatorcontrib>Germain, J.M.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>British journal of dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ortonne, J.P.</au><au>Paul, C.</au><au>Berardesca, E.</au><au>Marino, V.</au><au>Gallo, G.</au><au>Brault, Y.</au><au>Germain, J.M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2013-05</date><risdate>2013</risdate><volume>168</volume><issue>5</issue><spage>1080</spage><epage>1087</epage><pages>1080-1087</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><coden>BJDEAZ</coden><abstract>Summary
Background Nail psoriasis is common in patients with psoriasis and can seriously affect their quality of life. Current treatments are limited and there is no standard course of therapy.
Objectives To assess the efficacy and safety of etanercept (ETN) on nail psoriasis in patients with moderate‐to‐severe psoriasis.
Methods Patients with moderate‐to‐severe plaque psoriasis, who had previously failed at least one form of systemic therapy for nail psoriasis, were randomized to receive open‐label ETN 50 mg twice weekly (BIW) for 12 weeks followed by once weekly (QW) for 12 weeks (BIW/QW group) or ETN 50 mg QW for 24 weeks (QW/QW group). The primary endpoint was the mean improvement in the Nail Psoriasis Severity Index (NAPSI; score range 0–8) over 24 weeks in the target fingernail with the most severe abnormalities.
Results Seventy‐two patients received one or more doses of ETN (38 BIW/QW; 34 QW/QW) and 69 patients were included in the modified intent‐to‐treat population. At baseline, mean (standard error) target fingernail NAPSI score was 6·0 (0·3) in the BIW/QW group and 5·8 (0·3) in the QW/QW group. At week 24, mean target fingernail NAPSI score had decreased significantly by −4·3 [95% confidence interval (CI) −4·9 to −3·7; P < 0·0001] in the BIW/QW group and by −4·4 (95% CI −5·0 to −3·7; P < 0·0001) in the QW/QW group. Improvement in NAPSI showed significant correlation with Psoriasis Area and Severity Index improvement. ETN was well tolerated with no unexpected safety findings.
Conclusions Both ETN regimens were effective at treating nail psoriasis in this patient population.
What’s already known about this topic?
•
Nail psoriasis can be painful and severely debilitating.
•
Current treatments of nail psoriasis are limited.
•
Very few studies have specifically investigated the efficacy and safety of systemic antipsoriatic agents in nail psoriasis.
What does this study add?
•
This is the first randomized study specifically designed to investigate the effects of etanercept on nail psoriasis in patients with moderate‐to‐severe psoriasis.
•
The results of this study show nail psoriasis can be treated effectively with both treatment regimens of 50 mg etanercept twice weekly for 12 weeks followed by once weekly for 12 weeks and 50 mg etanercept once weekly for 24 weeks.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>23013207</pmid><doi>10.1111/bjd.12060</doi><tpages>8</tpages></addata></record> |
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| ispartof | British journal of dermatology (1951), 2013-05, Vol.168 (5), p.1080-1087 |
| issn | 0007-0963 1365-2133 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adult Biological and medical sciences Dermatology Dose-Response Relationship, Drug Drug Administration Schedule Etanercept Female Humans Immunoglobulin G - administration & dosage Immunoglobulin G - adverse effects Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - adverse effects Male Medical sciences Middle Aged Nail Diseases - drug therapy Nails Psoriasis - drug therapy Psoriasis. Parapsoriasis. Lichen Receptors, Tumor Necrosis Factor - administration & dosage Severity of Illness Index Time Factors Treatment Outcome Tumor Necrosis Factor-alpha - antagonists & inhibitors |
| title | A 24-week randomized clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis |
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