A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction
Summary Background In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated. Objectives To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept. Methods In this multicentre 24‐w...
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| Veröffentlicht in: | British journal of dermatology (1951) 2005-06, Vol.152 (6), p.1304-1312 |
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| container_title | British journal of dermatology (1951) |
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| creator | Papp, K.A. Tyring, S. Lahfa, M. Prinz, J. Griffiths, C.E.M. Nakanishi, A.M. Zitnik, R. Van De Kerkhof, P.C.M. |
| description | Summary
Background In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated.
Objectives To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept.
Methods In this multicentre 24‐week study in the U.S.A., Canada and Western Europe, patients were at least 18 years old; had active, clinically stable plaque psoriasis involving at least 10% of body surface area; had a minimum Psoriasis Area and Severity Index (PASI) of 10 at screening; and had received or were a candidate to receive systemic psoriasis therapy or phototherapy. During the first 12 weeks of the study, patients were randomly assigned to receive by subcutaneous injection etanercept twice weekly (BIW) at a dose of 50 mg or 25 mg, or placebo BIW in a double‐blind fashion. During the second 12 weeks, all patients received etanercept 25 mg BIW. The primary endpoint was a 75% or greater improvement from baseline in PASI (PASI 75) at 12 weeks.
Results Five hundred and eighty‐three subjects were randomized and received at least one dose of study drug. At week 12, a PASI 75 was achieved by 49% of patients in the etanercept 50 mg BIW group, 34% in the 25 mg BIW group, and 3% in the placebo group (P |
| doi_str_mv | 10.1111/j.1365-2133.2005.06688.x |
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Background In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated.
Objectives To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept.
Methods In this multicentre 24‐week study in the U.S.A., Canada and Western Europe, patients were at least 18 years old; had active, clinically stable plaque psoriasis involving at least 10% of body surface area; had a minimum Psoriasis Area and Severity Index (PASI) of 10 at screening; and had received or were a candidate to receive systemic psoriasis therapy or phototherapy. During the first 12 weeks of the study, patients were randomly assigned to receive by subcutaneous injection etanercept twice weekly (BIW) at a dose of 50 mg or 25 mg, or placebo BIW in a double‐blind fashion. During the second 12 weeks, all patients received etanercept 25 mg BIW. The primary endpoint was a 75% or greater improvement from baseline in PASI (PASI 75) at 12 weeks.
Results Five hundred and eighty‐three subjects were randomized and received at least one dose of study drug. At week 12, a PASI 75 was achieved by 49% of patients in the etanercept 50 mg BIW group, 34% in the 25 mg BIW group, and 3% in the placebo group (P < 0·0001 for each etanercept group compared with placebo). At week 24 (after 12 weeks of open‐label 25 mg etanercept BIW), a PASI 75 was achieved by 54% of patients whose dose was reduced from 50 mg BIW to 25 mg BIW, by 45% of patients in the continuous 25 mg BIW group, and by 28% in the group that received placebo followed by etanercept 25 mg BIW. Etanercept was well tolerated throughout the study.
Conclusions Etanercept provided clinically meaningful benefit to patients with chronic plaque psoriasis, with no apparent decrease in efficacy after dose reduction.</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/j.1365-2133.2005.06688.x</identifier><identifier>PMID: 15948997</identifier><identifier>CODEN: BJDEAZ</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biological and medical sciences ; cytokine ; Dermatology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Etanercept ; Female ; Humans ; Immunoglobulin G - administration & dosage ; Immunoglobulin G - therapeutic use ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - therapeutic use ; Injections, Subcutaneous ; Male ; Medical sciences ; Middle Aged ; phase III study ; psoriasis ; Psoriasis - drug therapy ; Psoriasis. Parapsoriasis. Lichen ; randomized controlled trial ; Receptors, Tumor Necrosis Factor - administration & dosage ; Receptors, Tumor Necrosis Factor - therapeutic use ; Recombinant Fusion Proteins - administration & dosage ; Recombinant Fusion Proteins - therapeutic use ; Statistics as Topic ; tumour necrosis factor</subject><ispartof>British journal of dermatology (1951), 2005-06, Vol.152 (6), p.1304-1312</ispartof><rights>2005 INIST-CNRS</rights><rights>Copyright Blackwell Publishing Jun 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5598-99a6a9ea4da3da2ee9be55baf7dbb7e6a2372a2a2bb7021ada7e8fdefa4043b03</citedby><cites>FETCH-LOGICAL-c5598-99a6a9ea4da3da2ee9be55baf7dbb7e6a2372a2a2bb7021ada7e8fdefa4043b03</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%2Fj.1365-2133.2005.06688.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2133.2005.06688.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16868772$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15948997$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Papp, K.A.</creatorcontrib><creatorcontrib>Tyring, S.</creatorcontrib><creatorcontrib>Lahfa, M.</creatorcontrib><creatorcontrib>Prinz, J.</creatorcontrib><creatorcontrib>Griffiths, C.E.M.</creatorcontrib><creatorcontrib>Nakanishi, A.M.</creatorcontrib><creatorcontrib>Zitnik, R.</creatorcontrib><creatorcontrib>Van De Kerkhof, P.C.M.</creatorcontrib><creatorcontrib>Etanercept Psoriasis Study Group</creatorcontrib><creatorcontrib>the Etanercept Psoriasis Study Group</creatorcontrib><title>A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated.
Objectives To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept.
Methods In this multicentre 24‐week study in the U.S.A., Canada and Western Europe, patients were at least 18 years old; had active, clinically stable plaque psoriasis involving at least 10% of body surface area; had a minimum Psoriasis Area and Severity Index (PASI) of 10 at screening; and had received or were a candidate to receive systemic psoriasis therapy or phototherapy. During the first 12 weeks of the study, patients were randomly assigned to receive by subcutaneous injection etanercept twice weekly (BIW) at a dose of 50 mg or 25 mg, or placebo BIW in a double‐blind fashion. During the second 12 weeks, all patients received etanercept 25 mg BIW. The primary endpoint was a 75% or greater improvement from baseline in PASI (PASI 75) at 12 weeks.
Results Five hundred and eighty‐three subjects were randomized and received at least one dose of study drug. At week 12, a PASI 75 was achieved by 49% of patients in the etanercept 50 mg BIW group, 34% in the 25 mg BIW group, and 3% in the placebo group (P < 0·0001 for each etanercept group compared with placebo). At week 24 (after 12 weeks of open‐label 25 mg etanercept BIW), a PASI 75 was achieved by 54% of patients whose dose was reduced from 50 mg BIW to 25 mg BIW, by 45% of patients in the continuous 25 mg BIW group, and by 28% in the group that received placebo followed by etanercept 25 mg BIW. Etanercept was well tolerated throughout the study.
Conclusions Etanercept provided clinically meaningful benefit to patients with chronic plaque psoriasis, with no apparent decrease in efficacy after dose reduction.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>cytokine</subject><subject>Dermatology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Etanercept</subject><subject>Female</subject><subject>Humans</subject><subject>Immunoglobulin G - administration & dosage</subject><subject>Immunoglobulin G - therapeutic use</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Injections, Subcutaneous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>phase III study</subject><subject>psoriasis</subject><subject>Psoriasis - drug therapy</subject><subject>Psoriasis. Parapsoriasis. Lichen</subject><subject>randomized controlled trial</subject><subject>Receptors, Tumor Necrosis Factor - administration & dosage</subject><subject>Receptors, Tumor Necrosis Factor - therapeutic use</subject><subject>Recombinant Fusion Proteins - administration & dosage</subject><subject>Recombinant Fusion Proteins - therapeutic use</subject><subject>Statistics as Topic</subject><subject>tumour necrosis factor</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkcFu1DAQhiMEotvCKyALCU5kseN1HCP1UFooCwUuRUhcrIkzAS_ZeLETscvTM2FXrcQF7INnNN8_tufPMib4XNB6vpoLWaq8EFLOC87VnJdlVc23d7LZTeFuNuOc65ybUh5lxymtOBeSK34_OxLKLCpj9CzbnbGvXaihY5tvkJAtl0sWoW_C2v_ChrnQDzF0HYVD9ESFluEAPUaHm4H5nm1SoELy6QVL0OKwe8awbb0DRxE1mjJ0wyRsAl0QsRnd4EP_ILvXQpfw4eE8yT69fnV9_ia_-ni5PD-7yp1SpsqNgRIMwqIB2UCBaGpUqoZWN3WtsYRC6gJoU8YLAQ1orNoGW1jwhay5PMme7vtuYvgxYhrs2ieHXUe_CGOypTaiqgr5T1BoVQgtFYGP_wJXYYw9fcKSGYIbmjNB1R5yMaQUsbWb6NcQd1ZwO5loV3byyk5eTTpl_5hotyR9dOg_1mtsboUH1wh4cgAgOehaMsz5dMuVVVlpXRB3uud--g53__0A-_LtxRSRPt_rfRpwe6OH-J2mJrWynz9c2nfy2nx5X2gKfgPKNMgG</recordid><startdate>200506</startdate><enddate>200506</enddate><creator>Papp, K.A.</creator><creator>Tyring, S.</creator><creator>Lahfa, M.</creator><creator>Prinz, J.</creator><creator>Griffiths, C.E.M.</creator><creator>Nakanishi, A.M.</creator><creator>Zitnik, R.</creator><creator>Van De Kerkhof, P.C.M.</creator><general>Blackwell Science Ltd</general><general>Blackwell</general><general>Oxford University Press</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>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7T2</scope><scope>7U2</scope><scope>C1K</scope><scope>7X8</scope></search><sort><creationdate>200506</creationdate><title>A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction</title><author>Papp, K.A. ; Tyring, S. ; Lahfa, M. ; Prinz, J. ; Griffiths, C.E.M. ; Nakanishi, A.M. ; Zitnik, R. ; Van De Kerkhof, P.C.M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5598-99a6a9ea4da3da2ee9be55baf7dbb7e6a2372a2a2bb7021ada7e8fdefa4043b03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>cytokine</topic><topic>Dermatology</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Etanercept</topic><topic>Female</topic><topic>Humans</topic><topic>Immunoglobulin G - administration & dosage</topic><topic>Immunoglobulin G - therapeutic use</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Injections, Subcutaneous</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>phase III study</topic><topic>psoriasis</topic><topic>Psoriasis - drug therapy</topic><topic>Psoriasis. Parapsoriasis. Lichen</topic><topic>randomized controlled trial</topic><topic>Receptors, Tumor Necrosis Factor - administration & dosage</topic><topic>Receptors, Tumor Necrosis Factor - therapeutic use</topic><topic>Recombinant Fusion Proteins - administration & dosage</topic><topic>Recombinant Fusion Proteins - therapeutic use</topic><topic>Statistics as Topic</topic><topic>tumour necrosis factor</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Papp, K.A.</creatorcontrib><creatorcontrib>Tyring, S.</creatorcontrib><creatorcontrib>Lahfa, M.</creatorcontrib><creatorcontrib>Prinz, J.</creatorcontrib><creatorcontrib>Griffiths, C.E.M.</creatorcontrib><creatorcontrib>Nakanishi, A.M.</creatorcontrib><creatorcontrib>Zitnik, R.</creatorcontrib><creatorcontrib>Van De Kerkhof, P.C.M.</creatorcontrib><creatorcontrib>Etanercept Psoriasis Study Group</creatorcontrib><creatorcontrib>the Etanercept Psoriasis Study Group</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>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Safety Science and Risk</collection><collection>Environmental Sciences and Pollution Management</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>Papp, K.A.</au><au>Tyring, S.</au><au>Lahfa, M.</au><au>Prinz, J.</au><au>Griffiths, C.E.M.</au><au>Nakanishi, A.M.</au><au>Zitnik, R.</au><au>Van De Kerkhof, P.C.M.</au><aucorp>Etanercept Psoriasis Study Group</aucorp><aucorp>the Etanercept Psoriasis Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2005-06</date><risdate>2005</risdate><volume>152</volume><issue>6</issue><spage>1304</spage><epage>1312</epage><pages>1304-1312</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><coden>BJDEAZ</coden><abstract>Summary
Background In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated.
Objectives To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept.
Methods In this multicentre 24‐week study in the U.S.A., Canada and Western Europe, patients were at least 18 years old; had active, clinically stable plaque psoriasis involving at least 10% of body surface area; had a minimum Psoriasis Area and Severity Index (PASI) of 10 at screening; and had received or were a candidate to receive systemic psoriasis therapy or phototherapy. During the first 12 weeks of the study, patients were randomly assigned to receive by subcutaneous injection etanercept twice weekly (BIW) at a dose of 50 mg or 25 mg, or placebo BIW in a double‐blind fashion. During the second 12 weeks, all patients received etanercept 25 mg BIW. The primary endpoint was a 75% or greater improvement from baseline in PASI (PASI 75) at 12 weeks.
Results Five hundred and eighty‐three subjects were randomized and received at least one dose of study drug. At week 12, a PASI 75 was achieved by 49% of patients in the etanercept 50 mg BIW group, 34% in the 25 mg BIW group, and 3% in the placebo group (P < 0·0001 for each etanercept group compared with placebo). At week 24 (after 12 weeks of open‐label 25 mg etanercept BIW), a PASI 75 was achieved by 54% of patients whose dose was reduced from 50 mg BIW to 25 mg BIW, by 45% of patients in the continuous 25 mg BIW group, and by 28% in the group that received placebo followed by etanercept 25 mg BIW. Etanercept was well tolerated throughout the study.
Conclusions Etanercept provided clinically meaningful benefit to patients with chronic plaque psoriasis, with no apparent decrease in efficacy after dose reduction.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>15948997</pmid><doi>10.1111/j.1365-2133.2005.06688.x</doi><tpages>9</tpages></addata></record> |
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| ispartof | British journal of dermatology (1951), 2005-06, Vol.152 (6), p.1304-1312 |
| issn | 0007-0963 1365-2133 |
| language | eng |
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| source | Oxford University Press Journals All Titles (1996-Current); Wiley Online Library - AutoHoldings Journals; MEDLINE |
| subjects | Adolescent Adult Aged Aged, 80 and over Biological and medical sciences cytokine Dermatology Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Etanercept Female Humans Immunoglobulin G - administration & dosage Immunoglobulin G - therapeutic use Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - therapeutic use Injections, Subcutaneous Male Medical sciences Middle Aged phase III study psoriasis Psoriasis - drug therapy Psoriasis. Parapsoriasis. Lichen randomized controlled trial Receptors, Tumor Necrosis Factor - administration & dosage Receptors, Tumor Necrosis Factor - therapeutic use Recombinant Fusion Proteins - administration & dosage Recombinant Fusion Proteins - therapeutic use Statistics as Topic tumour necrosis factor |
| title | A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction |
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