Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-year results from the randomised controlled trial IMAGE

Background In the IMAGEstudy, rituximab plus methotrexate (MTX) inhibited joint damage and improved clinical outcomes at 1 year in MTX-naïve patients with early active rheumatoid arthritis. Objective The aim of this study was to assess joint damage progression and clinical outcomes over 2 years. Met...

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Veröffentlicht in:Annals of the rheumatic diseases 2012-03, Vol.71 (3), p.351-357
Hauptverfasser: Tak, Paul P, Rigby, William, Rubbert-Roth, Andrea, Peterfy, Charles, van Vollenhoven, Ronald F, Stohl, William, Healy, Emma, Hessey, Eva, Reynard, Mark, Shaw, Tim
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container_end_page 357
container_issue 3
container_start_page 351
container_title Annals of the rheumatic diseases
container_volume 71
creator Tak, Paul P
Rigby, William
Rubbert-Roth, Andrea
Peterfy, Charles
van Vollenhoven, Ronald F
Stohl, William
Healy, Emma
Hessey, Eva
Reynard, Mark
Shaw, Tim
description Background In the IMAGEstudy, rituximab plus methotrexate (MTX) inhibited joint damage and improved clinical outcomes at 1 year in MTX-naïve patients with early active rheumatoid arthritis. Objective The aim of this study was to assess joint damage progression and clinical outcomes over 2 years. Methods Patients (n=755) were randomised to receive rituximab 2×500 mg+MTX, 2×1000 mg+MTX or placebo+MTX. The placebo-controlled period continued to week 104. Two-year end points were defined as secondary or exploratory and included change in total Genant-modified Sharp score (mTSS), total erosion score and joint space narrowing score from baseline to week 104. Clinical efficacy and physical function end points were also assessed. Results At 2 years, rituximab 2×1000 mg+MTX maintained inhibition of progressive joint damage versus MTX alone (mTSS change 0.41 vs 1.95; p
doi_str_mv 10.1136/annrheumdis-2011-200170
format Article
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Objective The aim of this study was to assess joint damage progression and clinical outcomes over 2 years. Methods Patients (n=755) were randomised to receive rituximab 2×500 mg+MTX, 2×1000 mg+MTX or placebo+MTX. The placebo-controlled period continued to week 104. Two-year end points were defined as secondary or exploratory and included change in total Genant-modified Sharp score (mTSS), total erosion score and joint space narrowing score from baseline to week 104. Clinical efficacy and physical function end points were also assessed. Results At 2 years, rituximab 2×1000 mg+MTX maintained inhibition of progressive joint damage versus MTX alone (mTSS change 0.41 vs 1.95; p&lt;0.0001 (79% inhibition)), and a higher proportion of patients receiving rituximab 2×1000 mg+MTX had no radiographic progression over 2 years compared with those receiving MTX alone (57% vs 37%; p&lt;0.0001). Contrary to 1-year results, exploratory analysis of rituximab 2×500 mg+MTX at 2 years showed that progressive joint damage was slowed by ∼61% versus placebo+MTX (mTSS, exploratory p=0.0041). Improvements in clinical signs and symptoms and physical function seen after 1 year in rituximab-treated patients versus those receiving placebo were maintained at year 2. Safety profiles were similar between groups. Conclusions Treatment with rituximab 2×1000 mg+MTX was associated with sustained improvements in radiographic, clinical and functional outcomes over 2 years. Clinical trials.gov identifier NCT00299104.</description><identifier>ISSN: 0003-4967</identifier><identifier>ISSN: 1468-2060</identifier><identifier>EISSN: 1468-2060</identifier><identifier>DOI: 10.1136/annrheumdis-2011-200170</identifier><identifier>PMID: 22012969</identifier><identifier>CODEN: ARDIAO</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Murine-Derived - administration &amp; dosage ; Antibodies, Monoclonal, Murine-Derived - adverse effects ; Antirheumatic Agents - administration &amp; dosage ; Antirheumatic Agents - adverse effects ; Arthritis, Rheumatoid - diagnostic imaging ; Arthritis, Rheumatoid - drug therapy ; Arthritis, Rheumatoid - physiopathology ; Biological and medical sciences ; Bones, joints and connective tissue. Antiinflammatory agents ; Clinical and Epidemiological Research ; Disease Progression ; Diseases of the osteoarticular system ; Dose-Response Relationship, Drug ; Drug dosages ; Drug Therapy, Combination ; Follow-Up Studies ; Humans ; Immunomodulators ; Inflammatory joint diseases ; Medical sciences ; Medicin och hälsovetenskap ; Methotrexate ; Methotrexate - administration &amp; dosage ; Methotrexate - adverse effects ; Middle Aged ; Mortality ; Pharmacology. Drug treatments ; Radiography ; Recovery of Function ; Rheumatism ; Rheumatoid arthritis ; Rituximab ; Severity of Illness Index ; Soil erosion ; TNF inhibitors ; Treatment Outcome ; Tumor necrosis factor-TNF ; Young Adult</subject><ispartof>Annals of the rheumatic diseases, 2012-03, Vol.71 (3), p.351-357</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>2015 INIST-CNRS</rights><rights>Copyright: 2012 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b676t-c0843ca0a1d18f20a851fcddc6563ebaaad0e7e5286d02d2a662af3b8192ee8e3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://ard.bmj.com/content/71/3/351.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://ard.bmj.com/content/71/3/351.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,552,780,784,885,3196,23571,27924,27925,77600,77631</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=26084237$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22012969$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:124026905$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Tak, Paul P</creatorcontrib><creatorcontrib>Rigby, William</creatorcontrib><creatorcontrib>Rubbert-Roth, Andrea</creatorcontrib><creatorcontrib>Peterfy, Charles</creatorcontrib><creatorcontrib>van Vollenhoven, Ronald F</creatorcontrib><creatorcontrib>Stohl, William</creatorcontrib><creatorcontrib>Healy, Emma</creatorcontrib><creatorcontrib>Hessey, Eva</creatorcontrib><creatorcontrib>Reynard, Mark</creatorcontrib><creatorcontrib>Shaw, Tim</creatorcontrib><title>Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-year results from the randomised controlled trial IMAGE</title><title>Annals of the rheumatic diseases</title><addtitle>Ann Rheum Dis</addtitle><description>Background In the IMAGEstudy, rituximab plus methotrexate (MTX) inhibited joint damage and improved clinical outcomes at 1 year in MTX-naïve patients with early active rheumatoid arthritis. Objective The aim of this study was to assess joint damage progression and clinical outcomes over 2 years. Methods Patients (n=755) were randomised to receive rituximab 2×500 mg+MTX, 2×1000 mg+MTX or placebo+MTX. The placebo-controlled period continued to week 104. Two-year end points were defined as secondary or exploratory and included change in total Genant-modified Sharp score (mTSS), total erosion score and joint space narrowing score from baseline to week 104. Clinical efficacy and physical function end points were also assessed. Results At 2 years, rituximab 2×1000 mg+MTX maintained inhibition of progressive joint damage versus MTX alone (mTSS change 0.41 vs 1.95; p&lt;0.0001 (79% inhibition)), and a higher proportion of patients receiving rituximab 2×1000 mg+MTX had no radiographic progression over 2 years compared with those receiving MTX alone (57% vs 37%; p&lt;0.0001). Contrary to 1-year results, exploratory analysis of rituximab 2×500 mg+MTX at 2 years showed that progressive joint damage was slowed by ∼61% versus placebo+MTX (mTSS, exploratory p=0.0041). Improvements in clinical signs and symptoms and physical function seen after 1 year in rituximab-treated patients versus those receiving placebo were maintained at year 2. Safety profiles were similar between groups. Conclusions Treatment with rituximab 2×1000 mg+MTX was associated with sustained improvements in radiographic, clinical and functional outcomes over 2 years. Clinical trials.gov identifier NCT00299104.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal, Murine-Derived - administration &amp; dosage</subject><subject>Antibodies, Monoclonal, Murine-Derived - adverse effects</subject><subject>Antirheumatic Agents - administration &amp; dosage</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Arthritis, Rheumatoid - diagnostic imaging</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Arthritis, Rheumatoid - physiopathology</subject><subject>Biological and medical sciences</subject><subject>Bones, joints and connective tissue. Antiinflammatory agents</subject><subject>Clinical and Epidemiological Research</subject><subject>Disease Progression</subject><subject>Diseases of the osteoarticular system</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug dosages</subject><subject>Drug Therapy, Combination</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Immunomodulators</subject><subject>Inflammatory joint diseases</subject><subject>Medical sciences</subject><subject>Medicin och hälsovetenskap</subject><subject>Methotrexate</subject><subject>Methotrexate - administration &amp; dosage</subject><subject>Methotrexate - adverse effects</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Pharmacology. Drug treatments</subject><subject>Radiography</subject><subject>Recovery of Function</subject><subject>Rheumatism</subject><subject>Rheumatoid arthritis</subject><subject>Rituximab</subject><subject>Severity of Illness Index</subject><subject>Soil erosion</subject><subject>TNF inhibitors</subject><subject>Treatment Outcome</subject><subject>Tumor necrosis factor-TNF</subject><subject>Young Adult</subject><issn>0003-4967</issn><issn>1468-2060</issn><issn>1468-2060</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>D8T</sourceid><recordid>eNqNkstu1DAUhiMEoqXwCmAJIbEJ2M7ESVggVVVbKhVYFChiY53EJ42nSTzYTi-PxRtyhplOWyQkNr7E3__n3JLkheBvhMjUWxhH3-E0GBtSyYWghYuCP0i2xUyVdFP8YbLNOc_SWaWKreRJCHO68lKUj5MtSRpZqWo7-XUyhQh2RMPs2NnaRutG5lq28O7MYwj2Atnc2TEyAwOcIbu0sWPexunKDlCzRT8FNmDsXPR4BRHJhyH4_ppBE5fqP4FCdNYw8LEjqQ3vmEyviWL0i6mPgbXeDSx2RMNo3GADBdS4MXrX93SM3kLPjj7uHu4_TR610Ad8tt53kq8H-1_2PqTHnw-P9naP01oVKqYNL2dZAxyEEWUrOZS5aBtjGpWrDGsAMBwLzGWpDJdGglIS2qwuRSURS8x2knTlGy5xMdV64Slff60dWL3-dE4n1PlMyDwnvvonT8U0t6IboZAzLlXFl9r3Ky0BA5oGKXHo71vcexltp8_chc5kURQyI4PXawPvfk4YoqYSNtj3MKKbghbU-XKWK6UIffkXOneTH6mUWpBZWZQUEFHFimq8C8FjuwlGcL0cQX1nBPVyBPVqBEn5_G4uG93NzBHwag1AaKBvqeMNeWw4RZ2TWXHbABsiXm3ewZ9rVWRFrj9929PfTw--nJz-qPQyMbni62H-39H-BoS2D2c</recordid><startdate>20120301</startdate><enddate>20120301</enddate><creator>Tak, Paul P</creator><creator>Rigby, William</creator><creator>Rubbert-Roth, Andrea</creator><creator>Peterfy, Charles</creator><creator>van Vollenhoven, Ronald F</creator><creator>Stohl, William</creator><creator>Healy, Emma</creator><creator>Hessey, Eva</creator><creator>Reynard, Mark</creator><creator>Shaw, Tim</creator><general>BMJ Publishing Group Ltd and European League Against Rheumatism</general><general>BMJ Publishing Group</general><general>BMJ Publishing Group LTD</general><general>BMJ Group</general><scope>9YT</scope><scope>ACMMV</scope><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>7T5</scope><scope>H94</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope></search><sort><creationdate>20120301</creationdate><title>Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-year results from the randomised controlled trial IMAGE</title><author>Tak, Paul P ; Rigby, William ; Rubbert-Roth, Andrea ; Peterfy, Charles ; van Vollenhoven, Ronald F ; Stohl, William ; Healy, Emma ; Hessey, Eva ; Reynard, Mark ; Shaw, Tim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b676t-c0843ca0a1d18f20a851fcddc6563ebaaad0e7e5286d02d2a662af3b8192ee8e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal, Murine-Derived - administration &amp; dosage</topic><topic>Antibodies, Monoclonal, Murine-Derived - adverse effects</topic><topic>Antirheumatic Agents - administration &amp; dosage</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Arthritis, Rheumatoid - diagnostic imaging</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthritis, Rheumatoid - physiopathology</topic><topic>Biological and medical sciences</topic><topic>Bones, joints and connective tissue. 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Objective The aim of this study was to assess joint damage progression and clinical outcomes over 2 years. Methods Patients (n=755) were randomised to receive rituximab 2×500 mg+MTX, 2×1000 mg+MTX or placebo+MTX. The placebo-controlled period continued to week 104. Two-year end points were defined as secondary or exploratory and included change in total Genant-modified Sharp score (mTSS), total erosion score and joint space narrowing score from baseline to week 104. Clinical efficacy and physical function end points were also assessed. Results At 2 years, rituximab 2×1000 mg+MTX maintained inhibition of progressive joint damage versus MTX alone (mTSS change 0.41 vs 1.95; p&lt;0.0001 (79% inhibition)), and a higher proportion of patients receiving rituximab 2×1000 mg+MTX had no radiographic progression over 2 years compared with those receiving MTX alone (57% vs 37%; p&lt;0.0001). Contrary to 1-year results, exploratory analysis of rituximab 2×500 mg+MTX at 2 years showed that progressive joint damage was slowed by ∼61% versus placebo+MTX (mTSS, exploratory p=0.0041). Improvements in clinical signs and symptoms and physical function seen after 1 year in rituximab-treated patients versus those receiving placebo were maintained at year 2. Safety profiles were similar between groups. Conclusions Treatment with rituximab 2×1000 mg+MTX was associated with sustained improvements in radiographic, clinical and functional outcomes over 2 years. Clinical trials.gov identifier NCT00299104.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and European League Against Rheumatism</pub><pmid>22012969</pmid><doi>10.1136/annrheumdis-2011-200170</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; BMJ Journals - NESLi2; SWEPUB Freely available online
subjects Adolescent
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Murine-Derived - administration & dosage
Antibodies, Monoclonal, Murine-Derived - adverse effects
Antirheumatic Agents - administration & dosage
Antirheumatic Agents - adverse effects
Arthritis, Rheumatoid - diagnostic imaging
Arthritis, Rheumatoid - drug therapy
Arthritis, Rheumatoid - physiopathology
Biological and medical sciences
Bones, joints and connective tissue. Antiinflammatory agents
Clinical and Epidemiological Research
Disease Progression
Diseases of the osteoarticular system
Dose-Response Relationship, Drug
Drug dosages
Drug Therapy, Combination
Follow-Up Studies
Humans
Immunomodulators
Inflammatory joint diseases
Medical sciences
Medicin och hälsovetenskap
Methotrexate
Methotrexate - administration & dosage
Methotrexate - adverse effects
Middle Aged
Mortality
Pharmacology. Drug treatments
Radiography
Recovery of Function
Rheumatism
Rheumatoid arthritis
Rituximab
Severity of Illness Index
Soil erosion
TNF inhibitors
Treatment Outcome
Tumor necrosis factor-TNF
Young Adult
title Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-year results from the randomised controlled trial IMAGE
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