Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial
Objective: To evaluate the efficacy and safety of infliximab through 1 year in patients with psoriatic arthritis (PsA) enrolled in the IMPACT 2 trial. Methods: In this double blind, placebo controlled, phase III study, 200 patients with active PsA were randomised to receive infusions of infliximab 5...
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Veröffentlicht in: | Annals of the rheumatic diseases 2007-04, Vol.66 (4), p.498-505 |
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creator | Kavanaugh, A Krueger, G G Beutler, A Guzzo, C Zhou, B Dooley, L T Mease, P J Gladman, D D de Vlam, K Geusens, P P Birbara, C Halter, D G Antoni, C |
description | Objective: To evaluate the efficacy and safety of infliximab through 1 year in patients with psoriatic arthritis (PsA) enrolled in the IMPACT 2 trial. Methods: In this double blind, placebo controlled, phase III study, 200 patients with active PsA were randomised to receive infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks thereafter through 1 year. Patients with persistent disease activity could enter early escape at week 16, and all remaining placebo patients crossed over to infliximab at week 24. Patients randomised to infliximab who had no response or who lost response could escalate their dose to 10 mg/kg starting at week 38. Clinical efficacy was assessed based on the proportion of patients achieving ACR 20 and PASI 75 responses. Major clinical response (that is, maintenance of ACR 70 response for 24 continuous weeks) was assessed for the first time in PsA. Results: Through 1 year of treatment, 58.9% and 61.4% of patients in the randomised infliximab and placebo/infliximab groups, respectively, achieved ACR 20; corresponding figures for PASI 75 were 50.0% and 60.3%. At week 54, major clinical response was achieved by 12.1% of patients in the infliximab group. The safety profile of infliximab through week 54 was consistent with that seen through week 24. Two malignancies occurred: basal cell skin cancer (placebo) and stage I Hodgkin’s lymphoma (infliximab). Conclusion: Infliximab maintains a high degree of clinical efficacy and continues to be well tolerated in patients with PsA through 1 year of treatment. |
doi_str_mv | 10.1136/ard.2006.058339 |
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fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_1856065</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>70269263</sourcerecordid><originalsourceid>FETCH-LOGICAL-b522t-289f8765c2018798f1028f1c4893f6d95398243940c817af469dea6c2369555d3</originalsourceid><addsrcrecordid>eNqFkUtv1DAUhSMEokNhzQ5ZQrBAytR24hcLpGp4jVQKQgWxszyOM-MhiYPtlPbf8FO5oxm1wIaFfWXd7x6d61MUjwmeE1LxExObOcWYzzGTVaXuFDNSc1lSzPHdYoYxrspacXFUPEhpC08sibxfHBFBSE2knBW_lkPb-SvfmxXqjR8ynIQM2vj1BjVuHZ1DoUW284O3pkPRpTEMySE_oNFk74ac0E-fN8jY7C8dGlOIHhoWmZg30WefENQwgR5B187EnV6OzuQehl_uFKcORNoYeiAdWn74dLq4QBQgb7qHxb3WdMk9OtTj4svbNxeL9-XZx3fLxelZuWKU5pJK1UrBmaWYSKFkSzCFy9ZSVS1vFKuUpHWlamwlEaatuWqc4ZZWXDHGmuq4eLXXHadV7xoL3qLp9Bjha-K1DsbrvzuD3-h1uNREMo45A4HnB4EYfkwuZd37ZF3XmcGFKWmBKVeUVwA-_QfchikOsJwmQgjJMKUCqJM9ZWNIKbr2xgrBepe9huz1Lnu9zx4mnvy5wS1_CBuAZwfAJMiyjWawPt1ykkmqBAGu3HM-ZXd10zfxu-aiEkyff11o9fqciM_fqMbAv9jzq377X5e_AW3b1I8</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1777850227</pqid></control><display><type>article</type><title>Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial</title><source>MEDLINE</source><source>BMJ Journals - NESLi2</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Kavanaugh, A ; Krueger, G G ; Beutler, A ; Guzzo, C ; Zhou, B ; Dooley, L T ; Mease, P J ; Gladman, D D ; de Vlam, K ; Geusens, P P ; Birbara, C ; Halter, D G ; Antoni, C</creator><creatorcontrib>Kavanaugh, A ; Krueger, G G ; Beutler, A ; Guzzo, C ; Zhou, B ; Dooley, L T ; Mease, P J ; Gladman, D D ; de Vlam, K ; Geusens, P P ; Birbara, C ; Halter, D G ; Antoni, C ; IMPACT 2 Study Group ; for the IMPACT 2 Study Group</creatorcontrib><description>Objective: To evaluate the efficacy and safety of infliximab through 1 year in patients with psoriatic arthritis (PsA) enrolled in the IMPACT 2 trial. Methods: In this double blind, placebo controlled, phase III study, 200 patients with active PsA were randomised to receive infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks thereafter through 1 year. Patients with persistent disease activity could enter early escape at week 16, and all remaining placebo patients crossed over to infliximab at week 24. Patients randomised to infliximab who had no response or who lost response could escalate their dose to 10 mg/kg starting at week 38. Clinical efficacy was assessed based on the proportion of patients achieving ACR 20 and PASI 75 responses. Major clinical response (that is, maintenance of ACR 70 response for 24 continuous weeks) was assessed for the first time in PsA. Results: Through 1 year of treatment, 58.9% and 61.4% of patients in the randomised infliximab and placebo/infliximab groups, respectively, achieved ACR 20; corresponding figures for PASI 75 were 50.0% and 60.3%. At week 54, major clinical response was achieved by 12.1% of patients in the infliximab group. The safety profile of infliximab through week 54 was consistent with that seen through week 24. Two malignancies occurred: basal cell skin cancer (placebo) and stage I Hodgkin’s lymphoma (infliximab). Conclusion: Infliximab maintains a high degree of clinical efficacy and continues to be well tolerated in patients with PsA through 1 year of treatment.</description><identifier>ISSN: 0003-4967</identifier><identifier>EISSN: 1468-2060</identifier><identifier>DOI: 10.1136/ard.2006.058339</identifier><identifier>PMID: 17114188</identifier><identifier>CODEN: ARDIAO</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><subject>ACR ; ACR 20 ; Adult ; adverse event ; alanine aminotransferase ; ALT ; American College of Rheumatology ; ANAs ; anti dsDNA ; antibodies to double stranded DNA ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; antinuclear antibodies ; Antirheumatic Agents - adverse effects ; Antirheumatic Agents - therapeutic use ; Arthritis ; Arthritis, Psoriatic - drug therapy ; Arthritis, Psoriatic - physiopathology ; Arthritis, Psoriatic - rehabilitation ; aspartate aminotransferase ; AST ; Biological and medical sciences ; body surface area ; BSA ; Dermatology ; Diseases of the osteoarticular system ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug dosages ; Extended Report ; Female ; Follow-Up Studies ; HAQ ; Health Assessment Questionnaire ; Humans ; Immunoglobulins ; Immunomodulators ; Inflammatory joint diseases ; Infliximab ; Male ; Medical sciences ; methotrexate ; Middle Aged ; Mortality ; MTX ; non-steroidal anti-inflammatory drugs ; NSAIDs ; PASI ; PASI 75 ; Pharmacology. Drug treatments ; PsA ; PsARC ; Psoriasis ; Psoriasis - drug therapy ; Psoriasis Area and Severity Index ; Psoriasis. Parapsoriasis. Lichen ; psoriatic arthritis ; Psoriatic Arthritis Response Criteria ; Quality of Life ; SAE ; serious adverse effect ; Severity of Illness Index ; SF-36 ; Short Form-36 ; Skin ; TNFα ; tumour necrosis factor α</subject><ispartof>Annals of the rheumatic diseases, 2007-04, Vol.66 (4), p.498-505</ispartof><rights>Copyright 2007 by Annals of the Rheumatic Diseases</rights><rights>2007 INIST-CNRS</rights><rights>Copyright: 2007 Copyright 2007 by Annals of the Rheumatic Diseases</rights><rights>Copyright © 2007 BMJ Publishing Group and European League Against Rheumatism</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b522t-289f8765c2018798f1028f1c4893f6d95398243940c817af469dea6c2369555d3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://ard.bmj.com/content/66/4/498.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://ard.bmj.com/content/66/4/498.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,230,314,727,780,784,885,3196,23571,27924,27925,53791,53793,77600,77631</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18582971$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17114188$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kavanaugh, A</creatorcontrib><creatorcontrib>Krueger, G G</creatorcontrib><creatorcontrib>Beutler, A</creatorcontrib><creatorcontrib>Guzzo, C</creatorcontrib><creatorcontrib>Zhou, B</creatorcontrib><creatorcontrib>Dooley, L T</creatorcontrib><creatorcontrib>Mease, P J</creatorcontrib><creatorcontrib>Gladman, D D</creatorcontrib><creatorcontrib>de Vlam, K</creatorcontrib><creatorcontrib>Geusens, P P</creatorcontrib><creatorcontrib>Birbara, C</creatorcontrib><creatorcontrib>Halter, D G</creatorcontrib><creatorcontrib>Antoni, C</creatorcontrib><creatorcontrib>IMPACT 2 Study Group</creatorcontrib><creatorcontrib>for the IMPACT 2 Study Group</creatorcontrib><title>Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial</title><title>Annals of the rheumatic diseases</title><addtitle>Ann Rheum Dis</addtitle><description>Objective: To evaluate the efficacy and safety of infliximab through 1 year in patients with psoriatic arthritis (PsA) enrolled in the IMPACT 2 trial. Methods: In this double blind, placebo controlled, phase III study, 200 patients with active PsA were randomised to receive infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks thereafter through 1 year. Patients with persistent disease activity could enter early escape at week 16, and all remaining placebo patients crossed over to infliximab at week 24. Patients randomised to infliximab who had no response or who lost response could escalate their dose to 10 mg/kg starting at week 38. Clinical efficacy was assessed based on the proportion of patients achieving ACR 20 and PASI 75 responses. Major clinical response (that is, maintenance of ACR 70 response for 24 continuous weeks) was assessed for the first time in PsA. Results: Through 1 year of treatment, 58.9% and 61.4% of patients in the randomised infliximab and placebo/infliximab groups, respectively, achieved ACR 20; corresponding figures for PASI 75 were 50.0% and 60.3%. At week 54, major clinical response was achieved by 12.1% of patients in the infliximab group. The safety profile of infliximab through week 54 was consistent with that seen through week 24. Two malignancies occurred: basal cell skin cancer (placebo) and stage I Hodgkin’s lymphoma (infliximab). Conclusion: Infliximab maintains a high degree of clinical efficacy and continues to be well tolerated in patients with PsA through 1 year of treatment.</description><subject>ACR</subject><subject>ACR 20</subject><subject>Adult</subject><subject>adverse event</subject><subject>alanine aminotransferase</subject><subject>ALT</subject><subject>American College of Rheumatology</subject><subject>ANAs</subject><subject>anti dsDNA</subject><subject>antibodies to double stranded DNA</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>antinuclear antibodies</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Arthritis</subject><subject>Arthritis, Psoriatic - drug therapy</subject><subject>Arthritis, Psoriatic - physiopathology</subject><subject>Arthritis, Psoriatic - rehabilitation</subject><subject>aspartate aminotransferase</subject><subject>AST</subject><subject>Biological and medical sciences</subject><subject>body surface area</subject><subject>BSA</subject><subject>Dermatology</subject><subject>Diseases of the osteoarticular system</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug dosages</subject><subject>Extended Report</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>HAQ</subject><subject>Health Assessment Questionnaire</subject><subject>Humans</subject><subject>Immunoglobulins</subject><subject>Immunomodulators</subject><subject>Inflammatory joint diseases</subject><subject>Infliximab</subject><subject>Male</subject><subject>Medical sciences</subject><subject>methotrexate</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>MTX</subject><subject>non-steroidal anti-inflammatory drugs</subject><subject>NSAIDs</subject><subject>PASI</subject><subject>PASI 75</subject><subject>Pharmacology. Drug treatments</subject><subject>PsA</subject><subject>PsARC</subject><subject>Psoriasis</subject><subject>Psoriasis - drug therapy</subject><subject>Psoriasis Area and Severity Index</subject><subject>Psoriasis. Parapsoriasis. Lichen</subject><subject>psoriatic arthritis</subject><subject>Psoriatic Arthritis Response Criteria</subject><subject>Quality of Life</subject><subject>SAE</subject><subject>serious adverse effect</subject><subject>Severity of Illness Index</subject><subject>SF-36</subject><subject>Short Form-36</subject><subject>Skin</subject><subject>TNFα</subject><subject>tumour necrosis factor α</subject><issn>0003-4967</issn><issn>1468-2060</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqFkUtv1DAUhSMEokNhzQ5ZQrBAytR24hcLpGp4jVQKQgWxszyOM-MhiYPtlPbf8FO5oxm1wIaFfWXd7x6d61MUjwmeE1LxExObOcWYzzGTVaXuFDNSc1lSzPHdYoYxrspacXFUPEhpC08sibxfHBFBSE2knBW_lkPb-SvfmxXqjR8ynIQM2vj1BjVuHZ1DoUW284O3pkPRpTEMySE_oNFk74ac0E-fN8jY7C8dGlOIHhoWmZg30WefENQwgR5B187EnV6OzuQehl_uFKcORNoYeiAdWn74dLq4QBQgb7qHxb3WdMk9OtTj4svbNxeL9-XZx3fLxelZuWKU5pJK1UrBmaWYSKFkSzCFy9ZSVS1vFKuUpHWlamwlEaatuWqc4ZZWXDHGmuq4eLXXHadV7xoL3qLp9Bjha-K1DsbrvzuD3-h1uNREMo45A4HnB4EYfkwuZd37ZF3XmcGFKWmBKVeUVwA-_QfchikOsJwmQgjJMKUCqJM9ZWNIKbr2xgrBepe9huz1Lnu9zx4mnvy5wS1_CBuAZwfAJMiyjWawPt1ykkmqBAGu3HM-ZXd10zfxu-aiEkyff11o9fqciM_fqMbAv9jzq377X5e_AW3b1I8</recordid><startdate>20070401</startdate><enddate>20070401</enddate><creator>Kavanaugh, A</creator><creator>Krueger, G G</creator><creator>Beutler, A</creator><creator>Guzzo, C</creator><creator>Zhou, B</creator><creator>Dooley, L T</creator><creator>Mease, P J</creator><creator>Gladman, D D</creator><creator>de Vlam, K</creator><creator>Geusens, P P</creator><creator>Birbara, C</creator><creator>Halter, D G</creator><creator>Antoni, C</creator><general>BMJ Publishing Group Ltd and European League Against Rheumatism</general><general>BMJ</general><general>BMJ Publishing Group LTD</general><general>BMJ Group</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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20070401</creationdate><title>Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial</title><author>Kavanaugh, A ; Krueger, G G ; Beutler, A ; Guzzo, C ; Zhou, B ; Dooley, L T ; Mease, P J ; Gladman, D D ; de Vlam, K ; Geusens, P P ; Birbara, C ; Halter, D G ; Antoni, C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b522t-289f8765c2018798f1028f1c4893f6d95398243940c817af469dea6c2369555d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>ACR</topic><topic>ACR 20</topic><topic>Adult</topic><topic>adverse event</topic><topic>alanine aminotransferase</topic><topic>ALT</topic><topic>American College of Rheumatology</topic><topic>ANAs</topic><topic>anti dsDNA</topic><topic>antibodies to double stranded DNA</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>antinuclear antibodies</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis</topic><topic>Arthritis, Psoriatic - drug therapy</topic><topic>Arthritis, Psoriatic - physiopathology</topic><topic>Arthritis, Psoriatic - rehabilitation</topic><topic>aspartate aminotransferase</topic><topic>AST</topic><topic>Biological and medical sciences</topic><topic>body surface area</topic><topic>BSA</topic><topic>Dermatology</topic><topic>Diseases of the osteoarticular system</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug dosages</topic><topic>Extended Report</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>HAQ</topic><topic>Health Assessment Questionnaire</topic><topic>Humans</topic><topic>Immunoglobulins</topic><topic>Immunomodulators</topic><topic>Inflammatory joint diseases</topic><topic>Infliximab</topic><topic>Male</topic><topic>Medical sciences</topic><topic>methotrexate</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>MTX</topic><topic>non-steroidal anti-inflammatory drugs</topic><topic>NSAIDs</topic><topic>PASI</topic><topic>PASI 75</topic><topic>Pharmacology. Drug treatments</topic><topic>PsA</topic><topic>PsARC</topic><topic>Psoriasis</topic><topic>Psoriasis - drug therapy</topic><topic>Psoriasis Area and Severity Index</topic><topic>Psoriasis. Parapsoriasis. Lichen</topic><topic>psoriatic arthritis</topic><topic>Psoriatic Arthritis Response Criteria</topic><topic>Quality of Life</topic><topic>SAE</topic><topic>serious adverse effect</topic><topic>Severity of Illness Index</topic><topic>SF-36</topic><topic>Short Form-36</topic><topic>Skin</topic><topic>TNFα</topic><topic>tumour necrosis factor α</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kavanaugh, A</creatorcontrib><creatorcontrib>Krueger, G G</creatorcontrib><creatorcontrib>Beutler, A</creatorcontrib><creatorcontrib>Guzzo, C</creatorcontrib><creatorcontrib>Zhou, B</creatorcontrib><creatorcontrib>Dooley, L T</creatorcontrib><creatorcontrib>Mease, P J</creatorcontrib><creatorcontrib>Gladman, D D</creatorcontrib><creatorcontrib>de Vlam, K</creatorcontrib><creatorcontrib>Geusens, P P</creatorcontrib><creatorcontrib>Birbara, C</creatorcontrib><creatorcontrib>Halter, D G</creatorcontrib><creatorcontrib>Antoni, C</creatorcontrib><creatorcontrib>IMPACT 2 Study Group</creatorcontrib><creatorcontrib>for the IMPACT 2 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>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Annals of the rheumatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kavanaugh, A</au><au>Krueger, G G</au><au>Beutler, A</au><au>Guzzo, C</au><au>Zhou, B</au><au>Dooley, L T</au><au>Mease, P J</au><au>Gladman, D D</au><au>de Vlam, K</au><au>Geusens, P P</au><au>Birbara, C</au><au>Halter, D G</au><au>Antoni, C</au><aucorp>IMPACT 2 Study Group</aucorp><aucorp>for the IMPACT 2 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial</atitle><jtitle>Annals of the rheumatic diseases</jtitle><addtitle>Ann Rheum Dis</addtitle><date>2007-04-01</date><risdate>2007</risdate><volume>66</volume><issue>4</issue><spage>498</spage><epage>505</epage><pages>498-505</pages><issn>0003-4967</issn><eissn>1468-2060</eissn><coden>ARDIAO</coden><abstract>Objective: To evaluate the efficacy and safety of infliximab through 1 year in patients with psoriatic arthritis (PsA) enrolled in the IMPACT 2 trial. Methods: In this double blind, placebo controlled, phase III study, 200 patients with active PsA were randomised to receive infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks thereafter through 1 year. Patients with persistent disease activity could enter early escape at week 16, and all remaining placebo patients crossed over to infliximab at week 24. Patients randomised to infliximab who had no response or who lost response could escalate their dose to 10 mg/kg starting at week 38. Clinical efficacy was assessed based on the proportion of patients achieving ACR 20 and PASI 75 responses. Major clinical response (that is, maintenance of ACR 70 response for 24 continuous weeks) was assessed for the first time in PsA. Results: Through 1 year of treatment, 58.9% and 61.4% of patients in the randomised infliximab and placebo/infliximab groups, respectively, achieved ACR 20; corresponding figures for PASI 75 were 50.0% and 60.3%. At week 54, major clinical response was achieved by 12.1% of patients in the infliximab group. The safety profile of infliximab through week 54 was consistent with that seen through week 24. Two malignancies occurred: basal cell skin cancer (placebo) and stage I Hodgkin’s lymphoma (infliximab). Conclusion: Infliximab maintains a high degree of clinical efficacy and continues to be well tolerated in patients with PsA through 1 year of treatment.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and European League Against Rheumatism</pub><pmid>17114188</pmid><doi>10.1136/ard.2006.058339</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_1856065 |
source | MEDLINE; BMJ Journals - NESLi2; EZB-FREE-00999 freely available EZB journals; PubMed Central |
subjects | ACR ACR 20 Adult adverse event alanine aminotransferase ALT American College of Rheumatology ANAs anti dsDNA antibodies to double stranded DNA Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use antinuclear antibodies Antirheumatic Agents - adverse effects Antirheumatic Agents - therapeutic use Arthritis Arthritis, Psoriatic - drug therapy Arthritis, Psoriatic - physiopathology Arthritis, Psoriatic - rehabilitation aspartate aminotransferase AST Biological and medical sciences body surface area BSA Dermatology Diseases of the osteoarticular system Dose-Response Relationship, Drug Double-Blind Method Drug dosages Extended Report Female Follow-Up Studies HAQ Health Assessment Questionnaire Humans Immunoglobulins Immunomodulators Inflammatory joint diseases Infliximab Male Medical sciences methotrexate Middle Aged Mortality MTX non-steroidal anti-inflammatory drugs NSAIDs PASI PASI 75 Pharmacology. Drug treatments PsA PsARC Psoriasis Psoriasis - drug therapy Psoriasis Area and Severity Index Psoriasis. Parapsoriasis. Lichen psoriatic arthritis Psoriatic Arthritis Response Criteria Quality of Life SAE serious adverse effect Severity of Illness Index SF-36 Short Form-36 Skin TNFα tumour necrosis factor α |
title | Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial |
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