A randomized, double-blind, placebo-controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis
Summary Background Etanercept plus methotrexate combination therapy has not been adequately investigated in psoriasis. Objectives To evaluate etanercept plus methotrexate vs. etanercept monotherapy in patients with moderate to severe plaque psoriasis who had not failed prior methotrexate or tumour...
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| Veröffentlicht in: | British journal of dermatology (1951) 2012-09, Vol.167 (3), p.649-657 |
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| container_title | British journal of dermatology (1951) |
| container_volume | 167 |
| creator | Gottlieb, A.B. Langley, R.G. Strober, B.E. Papp, K.A. Klekotka, P. Creamer, K. Thompson, E.H.Z. Hooper, M. Kricorian, G. |
| description | Summary
Background Etanercept plus methotrexate combination therapy has not been adequately investigated in psoriasis.
Objectives To evaluate etanercept plus methotrexate vs. etanercept monotherapy in patients with moderate to severe plaque psoriasis who had not failed prior methotrexate or tumour necrosis factor‐inhibitor therapy.
Methods Patients received etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks and were randomized 1 : 1 to receive methotrexate (7·5–15 mg weekly) or placebo. The primary endpoint was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 24.
Results In total, 239 patients were enrolled in each arm. PASI 75 was significantly higher at week 24 for the combination therapy group compared with the monotherapy group (77·3% vs. 60·3%; P |
| doi_str_mv | 10.1111/j.1365-2133.2012.11015.x |
| format | Article |
| fullrecord | <record><control><sourceid>istex_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3504074</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>ark_67375_WNG_J3MR89Z6_V</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5435-298e6e899204a5c79345bad7a1100b2d8c045ae2e41aba873f747c4ea798e0783</originalsourceid><addsrcrecordid>eNqNUU2P0zAQjRCILQt_AfnCjRQnduLkgrQssLBaQEJ8SFysiT2hLmmctZ1uy6_hp-K0pQs3fBmP5703M35JQjI6z-J5tpxnrCzSPGNsntMsj680K-abO8nsWLibzCilIqV1yU6SB94vKc0YLej95CTPC8Y4F7Pk1xlx0Gu7Mj9RPyXajk2HadOZPmZDBwobmyrbB2e7DjXxYdRbEizBNXQjBCRhgQS0NsHYntiWrDAsbHC42RUjMECPTuEQiOnJAMFgHzy5MWFBVlajO-A8rtHh1PN6jMFbZ8Ab_zC510Ln8dEhniafX7_6dP4mvfpw8fb87CpVBWdx47rCEqu6zimHQoma8aIBLSD-DG1yXSnKC8AceQYNVIK1ggvFEUQkUlGx0-T5XncYmxVqFYd00MnBmRW4rbRg5L-V3izkd7uWrKCcCh4Fqr2ActZ7h-2Rm1E5uSaXcjJHTubIyTW5c01uIvXx372PxD82RcCTAwC8gq6Nlinjb3ElE7zO2e0SN6bD7X8PIF9cvtxdo0C6FzA-4OYoAO6HLAUThfz6_kJesncfq_pbKb-w3w2exwY</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>A randomized, double-blind, placebo-controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Oxford University Press Journals All Titles (1996-Current)</source><creator>Gottlieb, A.B. ; Langley, R.G. ; Strober, B.E. ; Papp, K.A. ; Klekotka, P. ; Creamer, K. ; Thompson, E.H.Z. ; Hooper, M. ; Kricorian, G.</creator><creatorcontrib>Gottlieb, A.B. ; Langley, R.G. ; Strober, B.E. ; Papp, K.A. ; Klekotka, P. ; Creamer, K. ; Thompson, E.H.Z. ; Hooper, M. ; Kricorian, G.</creatorcontrib><description>Summary
Background Etanercept plus methotrexate combination therapy has not been adequately investigated in psoriasis.
Objectives To evaluate etanercept plus methotrexate vs. etanercept monotherapy in patients with moderate to severe plaque psoriasis who had not failed prior methotrexate or tumour necrosis factor‐inhibitor therapy.
Methods Patients received etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks and were randomized 1 : 1 to receive methotrexate (7·5–15 mg weekly) or placebo. The primary endpoint was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 24.
Results In total, 239 patients were enrolled in each arm. PASI 75 was significantly higher at week 24 for the combination therapy group compared with the monotherapy group (77·3% vs. 60·3%; P < 0·0001). Other PASI improvement scores at week 12 [PASI 75, 70·2% vs. 54·3% (P = 0·01); PASI 50, 92·4% vs. 83·8% (P = 0·01); and PASI 90, 34·0% vs. 23·1% (P = 0·03)] showed similar results as did week 24 PASI 50 (91·6% vs. 84·6%; P = 0·01) and PASI 90 (53·8% vs. 34·2%; P = 0·01). Significantly more patients receiving combination therapy than monotherapy had static Physician’s Global Assessment of clear/almost clear at week 12 (65·5% vs. 47·0%; P = 0·01) and week 24 (71·8% vs. 54·3%; P = 0·01). Adverse events (AEs) were reported in 74·9% and 59·8% of combination therapy and monotherapy groups, respectively; three serious AEs were reported in each arm.
Conclusions Combination therapy with etanercept plus methotrexate had acceptable tolerability and increased efficacy compared with etanercept monotherapy in patients with moderate to severe psoriasis.</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/j.1365-2133.2012.11015.x</identifier><identifier>PMID: 22533447</identifier><identifier>CODEN: BJDEAZ</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Administration, Cutaneous ; Biological and medical sciences ; Dermatologic Agents - administration & dosage ; Dermatologic Agents - adverse effects ; Dermatology ; Double-Blind Method ; Drug Therapy, Combination - methods ; Etanercept ; Female ; Humans ; Immunoglobulin G - administration & dosage ; Immunoglobulin G - adverse effects ; Male ; Medical sciences ; Methotrexate - administration & dosage ; Methotrexate - adverse effects ; Middle Aged ; Original ; Psoriasis - drug therapy ; Psoriasis. Parapsoriasis. Lichen ; Receptors, Tumor Necrosis Factor - administration & dosage ; Treatment Outcome</subject><ispartof>British journal of dermatology (1951), 2012-09, Vol.167 (3), p.649-657</ispartof><rights>2012 The Authors. BJD © 2012 British Association of Dermatologists</rights><rights>2015 INIST-CNRS</rights><rights>2012 The Authors. BJD © 2012 British Association of Dermatologists.</rights><rights>2012 The Authors. BJD © 2012 British Association of Dermatologists 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5435-298e6e899204a5c79345bad7a1100b2d8c045ae2e41aba873f747c4ea798e0783</citedby><cites>FETCH-LOGICAL-c5435-298e6e899204a5c79345bad7a1100b2d8c045ae2e41aba873f747c4ea798e0783</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.1365-2133.2012.11015.x$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2133.2012.11015.x$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,777,781,882,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26374923$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22533447$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gottlieb, A.B.</creatorcontrib><creatorcontrib>Langley, R.G.</creatorcontrib><creatorcontrib>Strober, B.E.</creatorcontrib><creatorcontrib>Papp, K.A.</creatorcontrib><creatorcontrib>Klekotka, P.</creatorcontrib><creatorcontrib>Creamer, K.</creatorcontrib><creatorcontrib>Thompson, E.H.Z.</creatorcontrib><creatorcontrib>Hooper, M.</creatorcontrib><creatorcontrib>Kricorian, G.</creatorcontrib><title>A randomized, double-blind, placebo-controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background Etanercept plus methotrexate combination therapy has not been adequately investigated in psoriasis.
Objectives To evaluate etanercept plus methotrexate vs. etanercept monotherapy in patients with moderate to severe plaque psoriasis who had not failed prior methotrexate or tumour necrosis factor‐inhibitor therapy.
Methods Patients received etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks and were randomized 1 : 1 to receive methotrexate (7·5–15 mg weekly) or placebo. The primary endpoint was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 24.
Results In total, 239 patients were enrolled in each arm. PASI 75 was significantly higher at week 24 for the combination therapy group compared with the monotherapy group (77·3% vs. 60·3%; P < 0·0001). Other PASI improvement scores at week 12 [PASI 75, 70·2% vs. 54·3% (P = 0·01); PASI 50, 92·4% vs. 83·8% (P = 0·01); and PASI 90, 34·0% vs. 23·1% (P = 0·03)] showed similar results as did week 24 PASI 50 (91·6% vs. 84·6%; P = 0·01) and PASI 90 (53·8% vs. 34·2%; P = 0·01). Significantly more patients receiving combination therapy than monotherapy had static Physician’s Global Assessment of clear/almost clear at week 12 (65·5% vs. 47·0%; P = 0·01) and week 24 (71·8% vs. 54·3%; P = 0·01). Adverse events (AEs) were reported in 74·9% and 59·8% of combination therapy and monotherapy groups, respectively; three serious AEs were reported in each arm.
Conclusions Combination therapy with etanercept plus methotrexate had acceptable tolerability and increased efficacy compared with etanercept monotherapy in patients with moderate to severe psoriasis.</description><subject>Administration, Cutaneous</subject><subject>Biological and medical sciences</subject><subject>Dermatologic Agents - administration & dosage</subject><subject>Dermatologic Agents - adverse effects</subject><subject>Dermatology</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination - methods</subject><subject>Etanercept</subject><subject>Female</subject><subject>Humans</subject><subject>Immunoglobulin G - administration & dosage</subject><subject>Immunoglobulin G - adverse effects</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Methotrexate - administration & dosage</subject><subject>Methotrexate - adverse effects</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Psoriasis - drug therapy</subject><subject>Psoriasis. Parapsoriasis. Lichen</subject><subject>Receptors, Tumor Necrosis Factor - administration & dosage</subject><subject>Treatment Outcome</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNqNUU2P0zAQjRCILQt_AfnCjRQnduLkgrQssLBaQEJ8SFysiT2hLmmctZ1uy6_hp-K0pQs3fBmP5703M35JQjI6z-J5tpxnrCzSPGNsntMsj680K-abO8nsWLibzCilIqV1yU6SB94vKc0YLej95CTPC8Y4F7Pk1xlx0Gu7Mj9RPyXajk2HadOZPmZDBwobmyrbB2e7DjXxYdRbEizBNXQjBCRhgQS0NsHYntiWrDAsbHC42RUjMECPTuEQiOnJAMFgHzy5MWFBVlajO-A8rtHh1PN6jMFbZ8Ab_zC510Ln8dEhniafX7_6dP4mvfpw8fb87CpVBWdx47rCEqu6zimHQoma8aIBLSD-DG1yXSnKC8AceQYNVIK1ggvFEUQkUlGx0-T5XncYmxVqFYd00MnBmRW4rbRg5L-V3izkd7uWrKCcCh4Fqr2ActZ7h-2Rm1E5uSaXcjJHTubIyTW5c01uIvXx372PxD82RcCTAwC8gq6Nlinjb3ElE7zO2e0SN6bD7X8PIF9cvtxdo0C6FzA-4OYoAO6HLAUThfz6_kJesncfq_pbKb-w3w2exwY</recordid><startdate>201209</startdate><enddate>201209</enddate><creator>Gottlieb, A.B.</creator><creator>Langley, R.G.</creator><creator>Strober, B.E.</creator><creator>Papp, K.A.</creator><creator>Klekotka, P.</creator><creator>Creamer, K.</creator><creator>Thompson, E.H.Z.</creator><creator>Hooper, M.</creator><creator>Kricorian, G.</creator><general>Blackwell Publishing Ltd</general><general>Wiley-Blackwell</general><scope>BSCLL</scope><scope>24P</scope><scope>WIN</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>5PM</scope></search><sort><creationdate>201209</creationdate><title>A randomized, double-blind, placebo-controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis</title><author>Gottlieb, A.B. ; Langley, R.G. ; Strober, B.E. ; Papp, K.A. ; Klekotka, P. ; Creamer, K. ; Thompson, E.H.Z. ; Hooper, M. ; Kricorian, G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5435-298e6e899204a5c79345bad7a1100b2d8c045ae2e41aba873f747c4ea798e0783</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Administration, Cutaneous</topic><topic>Biological and medical sciences</topic><topic>Dermatologic Agents - administration & dosage</topic><topic>Dermatologic Agents - adverse effects</topic><topic>Dermatology</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination - methods</topic><topic>Etanercept</topic><topic>Female</topic><topic>Humans</topic><topic>Immunoglobulin G - administration & dosage</topic><topic>Immunoglobulin G - adverse effects</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Methotrexate - administration & dosage</topic><topic>Methotrexate - adverse effects</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Psoriasis - drug therapy</topic><topic>Psoriasis. Parapsoriasis. Lichen</topic><topic>Receptors, Tumor Necrosis Factor - administration & dosage</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gottlieb, A.B.</creatorcontrib><creatorcontrib>Langley, R.G.</creatorcontrib><creatorcontrib>Strober, B.E.</creatorcontrib><creatorcontrib>Papp, K.A.</creatorcontrib><creatorcontrib>Klekotka, P.</creatorcontrib><creatorcontrib>Creamer, K.</creatorcontrib><creatorcontrib>Thompson, E.H.Z.</creatorcontrib><creatorcontrib>Hooper, M.</creatorcontrib><creatorcontrib>Kricorian, G.</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Wiley Free Content</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>PubMed Central (Full Participant titles)</collection><jtitle>British journal of dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gottlieb, A.B.</au><au>Langley, R.G.</au><au>Strober, B.E.</au><au>Papp, K.A.</au><au>Klekotka, P.</au><au>Creamer, K.</au><au>Thompson, E.H.Z.</au><au>Hooper, M.</au><au>Kricorian, G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized, double-blind, placebo-controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2012-09</date><risdate>2012</risdate><volume>167</volume><issue>3</issue><spage>649</spage><epage>657</epage><pages>649-657</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><coden>BJDEAZ</coden><abstract>Summary
Background Etanercept plus methotrexate combination therapy has not been adequately investigated in psoriasis.
Objectives To evaluate etanercept plus methotrexate vs. etanercept monotherapy in patients with moderate to severe plaque psoriasis who had not failed prior methotrexate or tumour necrosis factor‐inhibitor therapy.
Methods Patients received etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks and were randomized 1 : 1 to receive methotrexate (7·5–15 mg weekly) or placebo. The primary endpoint was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 24.
Results In total, 239 patients were enrolled in each arm. PASI 75 was significantly higher at week 24 for the combination therapy group compared with the monotherapy group (77·3% vs. 60·3%; P < 0·0001). Other PASI improvement scores at week 12 [PASI 75, 70·2% vs. 54·3% (P = 0·01); PASI 50, 92·4% vs. 83·8% (P = 0·01); and PASI 90, 34·0% vs. 23·1% (P = 0·03)] showed similar results as did week 24 PASI 50 (91·6% vs. 84·6%; P = 0·01) and PASI 90 (53·8% vs. 34·2%; P = 0·01). Significantly more patients receiving combination therapy than monotherapy had static Physician’s Global Assessment of clear/almost clear at week 12 (65·5% vs. 47·0%; P = 0·01) and week 24 (71·8% vs. 54·3%; P = 0·01). Adverse events (AEs) were reported in 74·9% and 59·8% of combination therapy and monotherapy groups, respectively; three serious AEs were reported in each arm.
Conclusions Combination therapy with etanercept plus methotrexate had acceptable tolerability and increased efficacy compared with etanercept monotherapy in patients with moderate to severe psoriasis.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>22533447</pmid><doi>10.1111/j.1365-2133.2012.11015.x</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Administration, Cutaneous Biological and medical sciences Dermatologic Agents - administration & dosage Dermatologic Agents - adverse effects Dermatology Double-Blind Method Drug Therapy, Combination - methods Etanercept Female Humans Immunoglobulin G - administration & dosage Immunoglobulin G - adverse effects Male Medical sciences Methotrexate - administration & dosage Methotrexate - adverse effects Middle Aged Original Psoriasis - drug therapy Psoriasis. Parapsoriasis. Lichen Receptors, Tumor Necrosis Factor - administration & dosage Treatment Outcome |
| title | A randomized, double-blind, placebo-controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis |
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