Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study)
Objectives In disease modifying antirheumatic drug (DMARD)-naive early rheumatoid arthritis (RA), to compare the efficacy of methotrexate (MTX) and infliximab (IFX) with MTX and intravenous corticosteroid for remission induction. Methods In a 78-week multicentre randomised controlled trial, double-b...
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| Veröffentlicht in: | Annals of the rheumatic diseases 2014-01, Vol.73 (1), p.75-85 |
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| creator | Nam, J L Villeneuve, E Hensor, E M A Conaghan, P G Keen, H I Buch, M H Gough, A K Green, M J Helliwell, P S Keenan, A M Morgan, A W Quinn, M Reece, R van der Heijde, D M Wakefield, R J Emery, P |
| description | Objectives In disease modifying antirheumatic drug (DMARD)-naive early rheumatoid arthritis (RA), to compare the efficacy of methotrexate (MTX) and infliximab (IFX) with MTX and intravenous corticosteroid for remission induction. Methods In a 78-week multicentre randomised controlled trial, double-blinded to week 26, 112 treatment-naive RA patients (1987 American College of Rheumatology classification criteria) with disease activity score 44 (DAS44)>2.4 were randomised to MTX + IFX or MTX + single dose intravenous methylprednisolone 250 mg. A treat-to-target approach was used with treatment escalation if DAS44>2.4. In the IFX group, IFX was discontinued for sustained remission (DAS44 |
| doi_str_mv | 10.1136/annrheumdis-2013-203440 |
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| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1777884372</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4008598021</sourcerecordid><originalsourceid>FETCH-LOGICAL-b384t-6f6641f9d9995a494aa256937dcd3f1ad8a1b3ee9a6ef80ff4d6af5d15ed42a43</originalsourceid><addsrcrecordid>eNqNUc1u1DAQjhCILoVXAEtcQFpDHHuTuLeqFKhUCQnBOZrE412vEnuxnZZ9VZ6GWaUgjlzsGfv7GfsrileifCeErN-D93GH82Rc4lUpJC1SqfJRsRKqbqmry8fFqixLyZWum7PiWUp7astWtE-Ls0pqUTW6XRW_vuLkUnLBM-fNPORTNYTpANH5LZ3Z0f10E_QMvGE7t91xExLSRY5whz7MiaWMMTizZjaMY7hHw_ojyxEh8xx4hrjFfMGAmTD3I_J-JKc1iyQYyBupHgLJEZmoOToYSZ55vOfBJ8zrRWtCn7kHd4fEPb0dMpkyiHkXXXaJvck7ZDcfri9poNkc3z4vnlgYE7542M-L7x-vv1195rdfPt1cXd7yXrYq89rWtRJWG631BpRWANWm1rIxg5FWgGlB9BJRQ422La1Vpga7MWKDRlWg5HnxetE9xPBjxpS7fZijJ8tONE3Ttko2FaGaBTXEkFJE2x0i_Ws8dqLsTpl2_2TanTLtlkyJ-fJBf-4nNH95f0IkQLUA-mn_36q_AXMkt0Q</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1777884372</pqid></control><display><type>article</type><title>Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study)</title><source>MEDLINE</source><source>BMJ Journals - NESLi2</source><creator>Nam, J L ; Villeneuve, E ; Hensor, E M A ; Conaghan, P G ; Keen, H I ; Buch, M H ; Gough, A K ; Green, M J ; Helliwell, P S ; Keenan, A M ; Morgan, A W ; Quinn, M ; Reece, R ; van der Heijde, D M ; Wakefield, R J ; Emery, P</creator><creatorcontrib>Nam, J L ; Villeneuve, E ; Hensor, E M A ; Conaghan, P G ; Keen, H I ; Buch, M H ; Gough, A K ; Green, M J ; Helliwell, P S ; Keenan, A M ; Morgan, A W ; Quinn, M ; Reece, R ; van der Heijde, D M ; Wakefield, R J ; Emery, P</creatorcontrib><description>Objectives In disease modifying antirheumatic drug (DMARD)-naive early rheumatoid arthritis (RA), to compare the efficacy of methotrexate (MTX) and infliximab (IFX) with MTX and intravenous corticosteroid for remission induction. Methods In a 78-week multicentre randomised controlled trial, double-blinded to week 26, 112 treatment-naive RA patients (1987 American College of Rheumatology classification criteria) with disease activity score 44 (DAS44)>2.4 were randomised to MTX + IFX or MTX + single dose intravenous methylprednisolone 250 mg. A treat-to-target approach was used with treatment escalation if DAS44>2.4. In the IFX group, IFX was discontinued for sustained remission (DAS44<1.6 for 6 months). The primary outcome was change in modified total Sharp-van der Heijde score (mTSS) at week 50. Results The mean changes in mTSS score at week 50 in the IFX and intravenous steroid groups were 1.20 units and 2.81 units, respectively (adjusted difference (95% CI) −1.45 (−3.35 to 0.45); p=0.132). Radiographic non-progression (mTSS<2.0) occurred in 81% vs 71% (OR 1.77 (0.56 to 5.61); p=0.328). DAS44 remission was achieved at week 50 in 49% and 36% (OR 2.13 (0.91 to 5.00); p=0.082), and at week 78 in 48% and 50% (OR 1.12 (0.47 to 2.68); p=0.792). Exploratory analyses suggested higher DAS28 remission at week 6 and less ultrasound synovitis at week 50 in the IFX group. Of the IFX group, 25% (14/55) achieved sustained remission and stopped IFX. No substantive differences in adverse events were seen. Conclusions In DMARD-naive early RA patients, initial therapy with MTX+high-dose intravenous steroid resulted in good disease control with little structural damage. MTX+IFX was not statistically superior to MTX+intravenous steroid when combined with a treat-to-target approach.</description><identifier>ISSN: 0003-4967</identifier><identifier>EISSN: 1468-2060</identifier><identifier>DOI: 10.1136/annrheumdis-2013-203440</identifier><identifier>PMID: 23912798</identifier><identifier>CODEN: ARDIAO</identifier><language>eng</language><publisher>England: Elsevier Limited</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - administration & dosage ; Antibodies, Monoclonal - adverse effects ; Antirheumatic Agents - administration & dosage ; Antirheumatic Agents - adverse effects ; Arthritis, Rheumatoid - diagnosis ; Arthritis, Rheumatoid - drug therapy ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; HIV ; Human immunodeficiency virus ; Humans ; Infliximab ; Injections, Intravenous ; Male ; Middle Aged ; Osteoporosis ; Remission Induction ; Rheumatoid arthritis ; Steroids - administration & dosage ; TNF inhibitors ; Treatment Outcome ; Tumor necrosis factor-TNF ; Young Adult</subject><ispartof>Annals of the rheumatic diseases, 2014-01, Vol.73 (1), p.75-85</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>Copyright: 2014 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><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b384t-6f6641f9d9995a494aa256937dcd3f1ad8a1b3ee9a6ef80ff4d6af5d15ed42a43</citedby><cites>FETCH-LOGICAL-b384t-6f6641f9d9995a494aa256937dcd3f1ad8a1b3ee9a6ef80ff4d6af5d15ed42a43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://ard.bmj.com/content/73/1/75.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://ard.bmj.com/content/73/1/75.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,314,776,780,3183,23550,27901,27902,77569,77600</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23912798$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nam, J L</creatorcontrib><creatorcontrib>Villeneuve, E</creatorcontrib><creatorcontrib>Hensor, E M A</creatorcontrib><creatorcontrib>Conaghan, P G</creatorcontrib><creatorcontrib>Keen, H I</creatorcontrib><creatorcontrib>Buch, M H</creatorcontrib><creatorcontrib>Gough, A K</creatorcontrib><creatorcontrib>Green, M J</creatorcontrib><creatorcontrib>Helliwell, P S</creatorcontrib><creatorcontrib>Keenan, A M</creatorcontrib><creatorcontrib>Morgan, A W</creatorcontrib><creatorcontrib>Quinn, M</creatorcontrib><creatorcontrib>Reece, R</creatorcontrib><creatorcontrib>van der Heijde, D M</creatorcontrib><creatorcontrib>Wakefield, R J</creatorcontrib><creatorcontrib>Emery, P</creatorcontrib><title>Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study)</title><title>Annals of the rheumatic diseases</title><addtitle>Ann Rheum Dis</addtitle><description>Objectives In disease modifying antirheumatic drug (DMARD)-naive early rheumatoid arthritis (RA), to compare the efficacy of methotrexate (MTX) and infliximab (IFX) with MTX and intravenous corticosteroid for remission induction. Methods In a 78-week multicentre randomised controlled trial, double-blinded to week 26, 112 treatment-naive RA patients (1987 American College of Rheumatology classification criteria) with disease activity score 44 (DAS44)>2.4 were randomised to MTX + IFX or MTX + single dose intravenous methylprednisolone 250 mg. A treat-to-target approach was used with treatment escalation if DAS44>2.4. In the IFX group, IFX was discontinued for sustained remission (DAS44<1.6 for 6 months). The primary outcome was change in modified total Sharp-van der Heijde score (mTSS) at week 50. Results The mean changes in mTSS score at week 50 in the IFX and intravenous steroid groups were 1.20 units and 2.81 units, respectively (adjusted difference (95% CI) −1.45 (−3.35 to 0.45); p=0.132). Radiographic non-progression (mTSS<2.0) occurred in 81% vs 71% (OR 1.77 (0.56 to 5.61); p=0.328). DAS44 remission was achieved at week 50 in 49% and 36% (OR 2.13 (0.91 to 5.00); p=0.082), and at week 78 in 48% and 50% (OR 1.12 (0.47 to 2.68); p=0.792). Exploratory analyses suggested higher DAS28 remission at week 6 and less ultrasound synovitis at week 50 in the IFX group. Of the IFX group, 25% (14/55) achieved sustained remission and stopped IFX. No substantive differences in adverse events were seen. Conclusions In DMARD-naive early RA patients, initial therapy with MTX+high-dose intravenous steroid resulted in good disease control with little structural damage. MTX+IFX was not statistically superior to MTX+intravenous steroid when combined with a treat-to-target approach.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - administration & dosage</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antirheumatic Agents - administration & dosage</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Arthritis, Rheumatoid - diagnosis</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Infliximab</subject><subject>Injections, Intravenous</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Osteoporosis</subject><subject>Remission Induction</subject><subject>Rheumatoid arthritis</subject><subject>Steroids - administration & dosage</subject><subject>TNF inhibitors</subject><subject>Treatment Outcome</subject><subject>Tumor necrosis factor-TNF</subject><subject>Young 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induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study)</title><author>Nam, J L ; Villeneuve, E ; Hensor, E M A ; Conaghan, P G ; Keen, H I ; Buch, M H ; Gough, A K ; Green, M J ; Helliwell, P S ; Keenan, A M ; Morgan, A W ; Quinn, M ; Reece, R ; van der Heijde, D M ; Wakefield, R J ; Emery, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b384t-6f6641f9d9995a494aa256937dcd3f1ad8a1b3ee9a6ef80ff4d6af5d15ed42a43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antibodies, Monoclonal - administration & dosage</topic><topic>Antibodies, Monoclonal - adverse effects</topic><topic>Antirheumatic Agents - administration & dosage</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Arthritis, Rheumatoid - diagnosis</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>HIV</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Infliximab</topic><topic>Injections, Intravenous</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Osteoporosis</topic><topic>Remission Induction</topic><topic>Rheumatoid arthritis</topic><topic>Steroids - administration & dosage</topic><topic>TNF inhibitors</topic><topic>Treatment Outcome</topic><topic>Tumor necrosis factor-TNF</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nam, J L</creatorcontrib><creatorcontrib>Villeneuve, E</creatorcontrib><creatorcontrib>Hensor, E M A</creatorcontrib><creatorcontrib>Conaghan, P 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Sciences</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><jtitle>Annals of the rheumatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nam, J L</au><au>Villeneuve, E</au><au>Hensor, E M A</au><au>Conaghan, P G</au><au>Keen, H I</au><au>Buch, M H</au><au>Gough, A K</au><au>Green, M J</au><au>Helliwell, P S</au><au>Keenan, A M</au><au>Morgan, A W</au><au>Quinn, M</au><au>Reece, R</au><au>van der Heijde, D M</au><au>Wakefield, R J</au><au>Emery, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study)</atitle><jtitle>Annals of the rheumatic diseases</jtitle><addtitle>Ann Rheum Dis</addtitle><date>2014-01</date><risdate>2014</risdate><volume>73</volume><issue>1</issue><spage>75</spage><epage>85</epage><pages>75-85</pages><issn>0003-4967</issn><eissn>1468-2060</eissn><coden>ARDIAO</coden><abstract>Objectives In disease modifying antirheumatic drug (DMARD)-naive early rheumatoid arthritis (RA), to compare the efficacy of methotrexate (MTX) and infliximab (IFX) with MTX and intravenous corticosteroid for remission induction. Methods In a 78-week multicentre randomised controlled trial, double-blinded to week 26, 112 treatment-naive RA patients (1987 American College of Rheumatology classification criteria) with disease activity score 44 (DAS44)>2.4 were randomised to MTX + IFX or MTX + single dose intravenous methylprednisolone 250 mg. A treat-to-target approach was used with treatment escalation if DAS44>2.4. In the IFX group, IFX was discontinued for sustained remission (DAS44<1.6 for 6 months). The primary outcome was change in modified total Sharp-van der Heijde score (mTSS) at week 50. Results The mean changes in mTSS score at week 50 in the IFX and intravenous steroid groups were 1.20 units and 2.81 units, respectively (adjusted difference (95% CI) −1.45 (−3.35 to 0.45); p=0.132). Radiographic non-progression (mTSS<2.0) occurred in 81% vs 71% (OR 1.77 (0.56 to 5.61); p=0.328). DAS44 remission was achieved at week 50 in 49% and 36% (OR 2.13 (0.91 to 5.00); p=0.082), and at week 78 in 48% and 50% (OR 1.12 (0.47 to 2.68); p=0.792). Exploratory analyses suggested higher DAS28 remission at week 6 and less ultrasound synovitis at week 50 in the IFX group. Of the IFX group, 25% (14/55) achieved sustained remission and stopped IFX. No substantive differences in adverse events were seen. Conclusions In DMARD-naive early RA patients, initial therapy with MTX+high-dose intravenous steroid resulted in good disease control with little structural damage. MTX+IFX was not statistically superior to MTX+intravenous steroid when combined with a treat-to-target approach.</abstract><cop>England</cop><pub>Elsevier Limited</pub><pmid>23912798</pmid><doi>10.1136/annrheumdis-2013-203440</doi><tpages>11</tpages></addata></record> |
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| subjects | Adolescent Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antirheumatic Agents - administration & dosage Antirheumatic Agents - adverse effects Arthritis, Rheumatoid - diagnosis Arthritis, Rheumatoid - drug therapy Dose-Response Relationship, Drug Double-Blind Method Female HIV Human immunodeficiency virus Humans Infliximab Injections, Intravenous Male Middle Aged Osteoporosis Remission Induction Rheumatoid arthritis Steroids - administration & dosage TNF inhibitors Treatment Outcome Tumor necrosis factor-TNF Young Adult |
| title | Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study) |
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