Magnetic resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring
The objective of this study was to compare the scope and the discriminative power of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) to those of semi-quantitative MRI scoring for evaluating treatments for rheumatoid arthritis (RA) in multicenter randomized clinical trials (RCTs). Sixt...
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| creator | Beals, Chan Baumgartner, Richard Peterfy, Charles Balanescu, Andra Mirea, Gavrila Harabagiu, Alexandru Popa, Serghei Cheng, Amy Feng, Dai Ashton, Edward DiCarlo, Julie Vallee, Marie-Helene Dardzinski, Bernard J |
| description | The objective of this study was to compare the scope and the discriminative power of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) to those of semi-quantitative MRI scoring for evaluating treatments for rheumatoid arthritis (RA) in multicenter randomized clinical trials (RCTs). Sixty-one patients with active RA participated in a double-blind, parallel group, randomized, multicenter methodology study receiving infliximab or placebo through 14 weeks. The most symptomatic wrist and metacarpophalangeal joints (MCPs) were imaged using MRI. In addition to clinical assessments with DAS28(CRP), the severity of inflammation was measured as synovial leak of gadolinium based contrast agent (GBCA) using DCE-MRI (Ktrans, primary endpoint) at weeks 0, 2, 4, and 14. Two radiologists independently scored synovitis, osteitis and erosion using RA MRI Score (RAMRIS) and cartilage loss using a 9-point MRI scale (CARLOS). Infliximab showed greater decrease from baseline in DAS28(CRP), DCE-MRI Ktrans of wrist and MCP synovium, and RAMRIS synovitis and osteitis at all visits compared with placebo (p |
| doi_str_mv | 10.1371/journal.pone.0187397 |
| format | Article |
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Sixty-one patients with active RA participated in a double-blind, parallel group, randomized, multicenter methodology study receiving infliximab or placebo through 14 weeks. The most symptomatic wrist and metacarpophalangeal joints (MCPs) were imaged using MRI. In addition to clinical assessments with DAS28(CRP), the severity of inflammation was measured as synovial leak of gadolinium based contrast agent (GBCA) using DCE-MRI (Ktrans, primary endpoint) at weeks 0, 2, 4, and 14. Two radiologists independently scored synovitis, osteitis and erosion using RA MRI Score (RAMRIS) and cartilage loss using a 9-point MRI scale (CARLOS). Infliximab showed greater decrease from baseline in DAS28(CRP), DCE-MRI Ktrans of wrist and MCP synovium, and RAMRIS synovitis and osteitis at all visits compared with placebo (p<0.001). Treatment effect sizes of infliximab therapy were similar for DAS28(CRP) (1.08; 90% CI (0.63-1.53)) and MRI inflammation endpoints: wrist Ktrans (1.00 (0.55-1.45)), RAMRIS synovitis (0.85 (0.38-1.28)) and RAMRIS osteitis (0.99 (0.52-1.43)). Damage measures of bone erosion (RAMRIS) and cartilage loss (CARLOS) were reduced with infliximab compared to with placebo at 14 weeks (p≤0.025). DCE-MRI and RAMRIS were equally sensitive and responsive to the anti-inflammatory effects of infliximab. RAMRIS and CARLOS showed suppression of erosion and cartilage loss, respectively, at 14 weeks. (ClinicalTrials.gov registration: NCT01313520).</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0187397</identifier><identifier>PMID: 29236711</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Arthritis ; Assessments ; Biology and Life Sciences ; Cartilage ; Clinical trials ; Complications and side effects ; Contrast media ; Diagnosis ; Dosage and administration ; Double-blind studies ; Drug therapy ; Engineering and Technology ; Gadolinium ; Immunotherapy ; Inflammation ; Infliximab ; Joint diseases ; Magnetic resonance ; Magnetic resonance imaging ; Medical research ; Medicine and Health Sciences ; Methods ; Monoclonal antibodies ; NMR ; Nuclear magnetic resonance ; Osteitis ; Patient outcomes ; Randomization ; Research and Analysis Methods ; Resonance ; Rheumatoid arthritis ; Rheumatology ; Synovitis ; Synovium ; TNF inhibitors ; Tumor necrosis factor-α ; Wrist</subject><ispartof>PloS one, 2017-12, Vol.12 (12), p.e0187397-e0187397</ispartof><rights>COPYRIGHT 2017 Public Library of Science</rights><rights>2017 Beals et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2017 Beals et al 2017 Beals et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-1a61132d0ba8eb77006f7e81ed79b5b763d87eb898a7563211f50ce5b2cd89143</citedby><cites>FETCH-LOGICAL-c692t-1a61132d0ba8eb77006f7e81ed79b5b763d87eb898a7563211f50ce5b2cd89143</cites><orcidid>0000-0003-4427-7637</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5728526/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5728526/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29236711$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Li, Xiaojuan</contributor><creatorcontrib>Beals, Chan</creatorcontrib><creatorcontrib>Baumgartner, Richard</creatorcontrib><creatorcontrib>Peterfy, Charles</creatorcontrib><creatorcontrib>Balanescu, Andra</creatorcontrib><creatorcontrib>Mirea, Gavrila</creatorcontrib><creatorcontrib>Harabagiu, Alexandru</creatorcontrib><creatorcontrib>Popa, Serghei</creatorcontrib><creatorcontrib>Cheng, Amy</creatorcontrib><creatorcontrib>Feng, Dai</creatorcontrib><creatorcontrib>Ashton, Edward</creatorcontrib><creatorcontrib>DiCarlo, Julie</creatorcontrib><creatorcontrib>Vallee, Marie-Helene</creatorcontrib><creatorcontrib>Dardzinski, Bernard J</creatorcontrib><title>Magnetic resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>The objective of this study was to compare the scope and the discriminative power of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) to those of semi-quantitative MRI scoring for evaluating treatments for rheumatoid arthritis (RA) in multicenter randomized clinical trials (RCTs). Sixty-one patients with active RA participated in a double-blind, parallel group, randomized, multicenter methodology study receiving infliximab or placebo through 14 weeks. The most symptomatic wrist and metacarpophalangeal joints (MCPs) were imaged using MRI. In addition to clinical assessments with DAS28(CRP), the severity of inflammation was measured as synovial leak of gadolinium based contrast agent (GBCA) using DCE-MRI (Ktrans, primary endpoint) at weeks 0, 2, 4, and 14. Two radiologists independently scored synovitis, osteitis and erosion using RA MRI Score (RAMRIS) and cartilage loss using a 9-point MRI scale (CARLOS). Infliximab showed greater decrease from baseline in DAS28(CRP), DCE-MRI Ktrans of wrist and MCP synovium, and RAMRIS synovitis and osteitis at all visits compared with placebo (p<0.001). Treatment effect sizes of infliximab therapy were similar for DAS28(CRP) (1.08; 90% CI (0.63-1.53)) and MRI inflammation endpoints: wrist Ktrans (1.00 (0.55-1.45)), RAMRIS synovitis (0.85 (0.38-1.28)) and RAMRIS osteitis (0.99 (0.52-1.43)). Damage measures of bone erosion (RAMRIS) and cartilage loss (CARLOS) were reduced with infliximab compared to with placebo at 14 weeks (p≤0.025). DCE-MRI and RAMRIS were equally sensitive and responsive to the anti-inflammatory effects of infliximab. RAMRIS and CARLOS showed suppression of erosion and cartilage loss, respectively, at 14 weeks. (ClinicalTrials.gov registration: NCT01313520).</description><subject>Arthritis</subject><subject>Assessments</subject><subject>Biology and Life Sciences</subject><subject>Cartilage</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Contrast media</subject><subject>Diagnosis</subject><subject>Dosage and administration</subject><subject>Double-blind studies</subject><subject>Drug therapy</subject><subject>Engineering and Technology</subject><subject>Gadolinium</subject><subject>Immunotherapy</subject><subject>Inflammation</subject><subject>Infliximab</subject><subject>Joint diseases</subject><subject>Magnetic resonance</subject><subject>Magnetic resonance imaging</subject><subject>Medical research</subject><subject>Medicine and Health Sciences</subject><subject>Methods</subject><subject>Monoclonal antibodies</subject><subject>NMR</subject><subject>Nuclear magnetic resonance</subject><subject>Osteitis</subject><subject>Patient outcomes</subject><subject>Randomization</subject><subject>Research and Analysis Methods</subject><subject>Resonance</subject><subject>Rheumatoid arthritis</subject><subject>Rheumatology</subject><subject>Synovitis</subject><subject>Synovium</subject><subject>TNF inhibitors</subject><subject>Tumor necrosis 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resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring</title><author>Beals, Chan ; Baumgartner, Richard ; Peterfy, Charles ; Balanescu, Andra ; Mirea, Gavrila ; Harabagiu, Alexandru ; Popa, Serghei ; Cheng, Amy ; Feng, Dai ; Ashton, Edward ; DiCarlo, Julie ; Vallee, Marie-Helene ; Dardzinski, Bernard J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-1a61132d0ba8eb77006f7e81ed79b5b763d87eb898a7563211f50ce5b2cd89143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Arthritis</topic><topic>Assessments</topic><topic>Biology and Life Sciences</topic><topic>Cartilage</topic><topic>Clinical trials</topic><topic>Complications and side effects</topic><topic>Contrast media</topic><topic>Diagnosis</topic><topic>Dosage and administration</topic><topic>Double-blind studies</topic><topic>Drug therapy</topic><topic>Engineering and Technology</topic><topic>Gadolinium</topic><topic>Immunotherapy</topic><topic>Inflammation</topic><topic>Infliximab</topic><topic>Joint diseases</topic><topic>Magnetic resonance</topic><topic>Magnetic resonance imaging</topic><topic>Medical research</topic><topic>Medicine and Health Sciences</topic><topic>Methods</topic><topic>Monoclonal antibodies</topic><topic>NMR</topic><topic>Nuclear magnetic resonance</topic><topic>Osteitis</topic><topic>Patient outcomes</topic><topic>Randomization</topic><topic>Research and Analysis Methods</topic><topic>Resonance</topic><topic>Rheumatoid arthritis</topic><topic>Rheumatology</topic><topic>Synovitis</topic><topic>Synovium</topic><topic>TNF inhibitors</topic><topic>Tumor necrosis 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with semi-quantitative scoring</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2017-12-13</date><risdate>2017</risdate><volume>12</volume><issue>12</issue><spage>e0187397</spage><epage>e0187397</epage><pages>e0187397-e0187397</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>The objective of this study was to compare the scope and the discriminative power of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) to those of semi-quantitative MRI scoring for evaluating treatments for rheumatoid arthritis (RA) in multicenter randomized clinical trials (RCTs). Sixty-one patients with active RA participated in a double-blind, parallel group, randomized, multicenter methodology study receiving infliximab or placebo through 14 weeks. The most symptomatic wrist and metacarpophalangeal joints (MCPs) were imaged using MRI. In addition to clinical assessments with DAS28(CRP), the severity of inflammation was measured as synovial leak of gadolinium based contrast agent (GBCA) using DCE-MRI (Ktrans, primary endpoint) at weeks 0, 2, 4, and 14. Two radiologists independently scored synovitis, osteitis and erosion using RA MRI Score (RAMRIS) and cartilage loss using a 9-point MRI scale (CARLOS). Infliximab showed greater decrease from baseline in DAS28(CRP), DCE-MRI Ktrans of wrist and MCP synovium, and RAMRIS synovitis and osteitis at all visits compared with placebo (p<0.001). Treatment effect sizes of infliximab therapy were similar for DAS28(CRP) (1.08; 90% CI (0.63-1.53)) and MRI inflammation endpoints: wrist Ktrans (1.00 (0.55-1.45)), RAMRIS synovitis (0.85 (0.38-1.28)) and RAMRIS osteitis (0.99 (0.52-1.43)). Damage measures of bone erosion (RAMRIS) and cartilage loss (CARLOS) were reduced with infliximab compared to with placebo at 14 weeks (p≤0.025). DCE-MRI and RAMRIS were equally sensitive and responsive to the anti-inflammatory effects of infliximab. RAMRIS and CARLOS showed suppression of erosion and cartilage loss, respectively, at 14 weeks. (ClinicalTrials.gov registration: NCT01313520).</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>29236711</pmid><doi>10.1371/journal.pone.0187397</doi><tpages>e0187397</tpages><orcidid>https://orcid.org/0000-0003-4427-7637</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2017-12, Vol.12 (12), p.e0187397-e0187397 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1976410199 |
| source | Public Library of Science; DOAJ Directory of Open Access Journals; PubMed Central; Free Full-Text Journals in Chemistry; EZB Electronic Journals Library |
| subjects | Arthritis Assessments Biology and Life Sciences Cartilage Clinical trials Complications and side effects Contrast media Diagnosis Dosage and administration Double-blind studies Drug therapy Engineering and Technology Gadolinium Immunotherapy Inflammation Infliximab Joint diseases Magnetic resonance Magnetic resonance imaging Medical research Medicine and Health Sciences Methods Monoclonal antibodies NMR Nuclear magnetic resonance Osteitis Patient outcomes Randomization Research and Analysis Methods Resonance Rheumatoid arthritis Rheumatology Synovitis Synovium TNF inhibitors Tumor necrosis factor-α Wrist |
| title | Magnetic resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-20T17%3A52%3A32IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Magnetic%20resonance%20imaging%20of%20the%20hand%20and%20wrist%20in%20a%20randomized,%20double-blind,%20multicenter,%20placebo-controlled%20trial%20of%20infliximab%20for%20rheumatoid%20arthritis:%20Comparison%20of%20dynamic%20contrast%20enhanced%20assessments%20with%20semi-quantitative%20scoring&rft.jtitle=PloS%20one&rft.au=Beals,%20Chan&rft.date=2017-12-13&rft.volume=12&rft.issue=12&rft.spage=e0187397&rft.epage=e0187397&rft.pages=e0187397-e0187397&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0187397&rft_dat=%3Cgale_plos_%3EA518695779%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1976410199&rft_id=info:pmid/29236711&rft_galeid=A518695779&rft_doaj_id=oai_doaj_org_article_f5616135f22940c7bea6c0bcac1008f8&rfr_iscdi=true |