Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement
Identifieur interne : 001730 ( Istex/Corpus ); précédent : 001729; suivant : 001731Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement
Auteurs : Fariz Yahya ; Raja Jasmin ; Chin Teck Ng ; Tien Eang Cheah ; Sargunan SockalingamSource :
- International Journal of Rheumatic Diseases [ 1756-1841 ] ; 2013-12.
English descriptors
- Teeft :
- Adverse events, Aiha, Azathioprine, Baseline, Control group, Disease activity index, Erythematosus, Glucocorticoid, Immunological parameters, International journal, Lupus, Mycophenolate, Mycophenolate group, Mycophenolate mofetil, Mycophenolate sodium, Positive trend, Prednisolone, Renal, Renal involvement, Rheumatic diseases, Side effects, Sledai, Sledai score, Sledai scores, Statistical difference, Steroid dose reduction, Study subjects, Systemic lupus erythematosus, Treatment groups.
Abstract
Aim: Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (SLE) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra‐renal SLE involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra‐renal SLE. Methods: A total of 14 SLE patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included SLE Disease Activity Index (SLEDAI) score, other organ‐specific parameters and immunological parameters, including anti‐double stranded DNA and C3. Steroid‐sparing effect of mycophenolate sodium was also evaluated. Results: Mycophenolate sodium produced a significant reduction in SLEDAI scores (P < 0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ‐specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. No major adverse events were reported in this study. Conclusion: Mycophenolate sodium is a safe alternative therapy in SLE patients with extra‐renal involvement. The reduction in SLEDAI scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non‐renal SLE is warranted.
Url:
DOI: 10.1111/1756-185X.12179
Links to Exploration step
ISTEX:5B414AF73A3A3C1212096C9A68A00CC923BEBDDDLe document en format XML
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uniqKey="Ng C" first="Chin Teck" last="Ng">Chin Teck Ng</name><affiliation><mods:affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</mods:affiliation></affiliation></author><author><name sortKey="Cheah, Tien Eang" sort="Cheah, Tien Eang" uniqKey="Cheah T" first="Tien Eang" last="Cheah">Tien Eang Cheah</name><affiliation><mods:affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</mods:affiliation></affiliation></author><author><name sortKey="Sockalingam, Sargunan" sort="Sockalingam, Sargunan" uniqKey="Sockalingam S" first="Sargunan" last="Sockalingam">Sargunan Sockalingam</name><affiliation><mods:affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</mods:affiliation></affiliation><affiliation><mods:affiliation>: Dr Sargunan Sockalingam, Department of Medicine, Faculty of Medicine, University Malaya, Lembah Pantai, 50603 Kuala Lumpur, Malaysia.Email:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: sargunan@um.edu.my</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:5B414AF73A3A3C1212096C9A68A00CC923BEBDDD</idno><date when="2013" year="2013">2013</date><idno type="doi">10.1111/1756-185X.12179</idno><idno type="url">https://api.istex.fr/ark:/67375/WNG-ZX9ZQQC1-9/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">001730</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001730</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main">Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement</title><author><name sortKey="Yahya, Fariz" sort="Yahya, Fariz" uniqKey="Yahya F" first="Fariz" last="Yahya">Fariz Yahya</name><affiliation><mods:affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</mods:affiliation></affiliation></author><author><name sortKey="Jasmin, Raja" sort="Jasmin, Raja" uniqKey="Jasmin R" first="Raja" last="Jasmin">Raja Jasmin</name><affiliation><mods:affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</mods:affiliation></affiliation></author><author><name sortKey="Ng, Chin Teck" sort="Ng, Chin Teck" uniqKey="Ng C" first="Chin Teck" last="Ng">Chin Teck Ng</name><affiliation><mods:affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</mods:affiliation></affiliation></author><author><name sortKey="Cheah, Tien Eang" sort="Cheah, Tien Eang" uniqKey="Cheah T" first="Tien Eang" last="Cheah">Tien Eang Cheah</name><affiliation><mods:affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</mods:affiliation></affiliation></author><author><name sortKey="Sockalingam, Sargunan" sort="Sockalingam, Sargunan" uniqKey="Sockalingam S" first="Sargunan" last="Sockalingam">Sargunan Sockalingam</name><affiliation><mods:affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</mods:affiliation></affiliation><affiliation><mods:affiliation>: Dr Sargunan Sockalingam, Department of Medicine, Faculty of Medicine, University Malaya, Lembah Pantai, 50603 Kuala Lumpur, Malaysia.Email:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: sargunan@um.edu.my</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">International Journal of Rheumatic Diseases</title><title level="j" type="alt">INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES</title><idno type="ISSN">1756-1841</idno><idno type="eISSN">1756-185X</idno><imprint><biblScope unit="vol">16</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="724">724</biblScope><biblScope unit="page" to="730">730</biblScope><biblScope unit="page-count">7</biblScope><date type="published" when="2013-12">2013-12</date></imprint><idno type="ISSN">1756-1841</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1756-1841</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Adverse events</term><term>Aiha</term><term>Azathioprine</term><term>Baseline</term><term>Control group</term><term>Disease activity index</term><term>Erythematosus</term><term>Glucocorticoid</term><term>Immunological parameters</term><term>International journal</term><term>Lupus</term><term>Mycophenolate</term><term>Mycophenolate group</term><term>Mycophenolate mofetil</term><term>Mycophenolate sodium</term><term>Positive trend</term><term>Prednisolone</term><term>Renal</term><term>Renal involvement</term><term>Rheumatic diseases</term><term>Side effects</term><term>Sledai</term><term>Sledai score</term><term>Sledai scores</term><term>Statistical difference</term><term>Steroid dose reduction</term><term>Study subjects</term><term>Systemic lupus erythematosus</term><term>Treatment groups</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract">Aim: Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (SLE) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra‐renal SLE involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra‐renal SLE. Methods: A total of 14 SLE patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included SLE Disease Activity Index (SLEDAI) score, other organ‐specific parameters and immunological parameters, including anti‐double stranded DNA and C3. Steroid‐sparing effect of mycophenolate sodium was also evaluated. Results: Mycophenolate sodium produced a significant reduction in SLEDAI scores (P < 0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ‐specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. No major adverse events were reported in this study. Conclusion: Mycophenolate sodium is a safe alternative therapy in SLE patients with extra‐renal involvement. The reduction in SLEDAI scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non‐renal SLE is warranted.</div></front></TEI><istex><corpusName>wiley</corpusName><keywords><teeft><json:string>mycophenolate</json:string><json:string>mycophenolate sodium</json:string><json:string>sledai</json:string><json:string>lupus</json:string><json:string>mycophenolate group</json:string><json:string>control group</json:string><json:string>aiha</json:string><json:string>glucocorticoid</json:string><json:string>baseline</json:string><json:string>azathioprine</json:string><json:string>erythematosus</json:string><json:string>prednisolone</json:string><json:string>rheumatic diseases</json:string><json:string>sledai scores</json:string><json:string>international journal</json:string><json:string>systemic lupus erythematosus</json:string><json:string>side effects</json:string><json:string>treatment groups</json:string><json:string>mycophenolate mofetil</json:string><json:string>positive trend</json:string><json:string>renal</json:string><json:string>disease activity index</json:string><json:string>renal involvement</json:string><json:string>immunological parameters</json:string><json:string>sledai score</json:string><json:string>study subjects</json:string><json:string>adverse events</json:string><json:string>statistical difference</json:string><json:string>steroid dose reduction</json:string></teeft></keywords><author><json:item><name>Fariz Yahya</name><affiliations><json:string>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</json:string></affiliations></json:item><json:item><name>Raja Jasmin</name><affiliations><json:string>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</json:string></affiliations></json:item><json:item><name>Chin Teck Ng</name><affiliations><json:string>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</json:string></affiliations></json:item><json:item><name>Tien Eang Cheah</name><affiliations><json:string>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</json:string></affiliations></json:item><json:item><name>Sargunan Sockalingam</name><affiliations><json:string>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</json:string><json:string>: Dr Sargunan Sockalingam, Department of Medicine, Faculty of Medicine, University Malaya, Lembah Pantai, 50603 Kuala Lumpur, Malaysia.Email:</json:string><json:string>E-mail: sargunan@um.edu.my</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>autoimmune</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>extra‐renal</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>immunosuppression</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>mycophenolate sodium</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>SLEDAI</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>systemic lupus erythematosus</value></json:item></subject><articleId><json:string>APL12179</json:string></articleId><arkIstex>ark:/67375/WNG-ZX9ZQQC1-9</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>Aim: Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (SLE) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra‐renal SLE involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra‐renal SLE. Methods: A total of 14 SLE patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included SLE Disease Activity Index (SLEDAI) score, other organ‐specific parameters and immunological parameters, including anti‐double stranded DNA and C3. Steroid‐sparing effect of mycophenolate sodium was also evaluated. Results: Mycophenolate sodium produced a significant reduction in SLEDAI scores (P > 0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ‐specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. No major adverse events were reported in this study. Conclusion: Mycophenolate sodium is a safe alternative therapy in SLE patients with extra‐renal involvement. The reduction in SLEDAI scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non‐renal SLE is warranted.</abstract><qualityIndicators><score>7.4</score><pdfWordCount>3036</pdfWordCount><pdfCharCount>19592</pdfCharCount><pdfVersion>1.7</pdfVersion><pdfPageCount>7</pdfPageCount><pdfPageSize>593.972 x 782.986 pts</pdfPageSize><pdfWordsPerPage>434</pdfWordsPerPage><pdfText>true</pdfText><refBibsNative>true</refBibsNative><abstractWordCount>197</abstractWordCount><abstractCharCount>1426</abstractCharCount><keywordCount>6</keywordCount></qualityIndicators><title>Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement</title><pmid><json:string>24119227</json:string></pmid><genre><json:string>article</json:string></genre><host><title>International Journal of Rheumatic Diseases</title><language><json:string>unknown</json:string></language><doi><json:string>10.1111/(ISSN)1756-185X</json:string></doi><issn><json:string>1756-1841</json:string></issn><eissn><json:string>1756-185X</json:string></eissn><publisherId><json:string>APL</json:string></publisherId><volume>16</volume><issue>6</issue><pages><first>724</first><last>730</last><total>7</total></pages><genre><json:string>journal</json:string></genre><subject><json:item><value>Original Article</value></json:item><json:item><value>Original articles</value></json:item></subject></host><namedEntities><unitex><date><json:string>from June 2011 to February 2012</json:string><json:string>2013-09-19</json:string></date><geogName></geogName><orgName><json:string>SPSS Inc., Chicago</json:string><json:string>National Centre for Adverse Drug Reaction Monitoring</json:string><json:string>Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia Abstract Aim</json:string><json:string>Ministry of Health</json:string><json:string>British Isles International Journal</json:string><json:string>ACR</json:string><json:string>Wiley Publishing Asia Pty Ltd</json:string><json:string>American College of Rheumatology</json:string><json:string>Department of Medicine, Faculty of Medicine, University Malaya, Lembah Pantai</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>Asia Paci</json:string><json:string>Sargunan Sockalingam</json:string></persName><placeName><json:string>Malaysia</json:string><json:string>Helsinki</json:string></placeName><ref_url></ref_url><ref_bibl><json:string>Karim et al.</json:string><json:string>Zeher et al.</json:string><json:string>F. Yahya et al.</json:string></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/WNG-ZX9ZQQC1-9</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - rheumatology</json:string></wos><scienceMetrix></scienceMetrix><scopus><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Rheumatology</json:string></scopus><inist><json:string>1 - sciences appliquees, technologies et medecines</json:string><json:string>2 - sciences biologiques et medicales</json:string><json:string>3 - sciences medicales</json:string></inist></categories><publicationDate>2013</publicationDate><copyrightDate>2013</copyrightDate><doi><json:string>10.1111/1756-185X.12179</json:string></doi><id>5B414AF73A3A3C1212096C9A68A00CC923BEBDDD</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-ZX9ZQQC1-9/fulltext.pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-ZX9ZQQC1-9/bundle.zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/ark:/67375/WNG-ZX9ZQQC1-9/fulltext.tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main">Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher ref="https://scientific-publisher.data.istex.fr/ark:/67375/H02-QW5Q88H5-V">Wiley Publishing Ltd</publisher><availability><licence>© 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd</licence></availability><date type="published" when="2013-12"></date></publicationStmt><notesStmt><note type="content-type" subtype="article" source="article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</note><note type="publication-type" subtype="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="article"><analytic><title level="a" type="main">Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement</title><author xml:id="author-0000"><persName><forename type="first">Fariz</forename><surname>Yahya</surname></persName><affiliation><orgName type="division">Division of Rheumatology</orgName>
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<orgName type="division">Department of Medicine</orgName>
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<country key="MY" xml:lang="en">MALAYSIA</country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">Chin Teck</forename><surname>Ng</surname></persName><affiliation><orgName type="division">Division of Rheumatology</orgName>
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<orgName type="division">Department of Medicine</orgName>
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<ref target="http://www.tei-c.org/">We use TEI</ref></desc></application></appInfo></encodingDesc><profileDesc><abstract style="main" xml:id="apl12179-abs-0001"><head>Abstract</head><head>Aim</head><p>Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (<hi rend="fc">SLE</hi>) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra‐renal <hi rend="fc">SLE</hi> involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra‐renal <hi rend="fc">SLE</hi>.</p><head>Methods</head><p>A total of 14 <hi rend="fc">SLE</hi> patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included <hi rend="fc">SLE D</hi>isease <hi rend="fc">A</hi>ctivity <hi rend="fc">I</hi>ndex (<hi rend="fc">SLEDAI</hi>) score, other organ‐specific parameters and immunological parameters, including anti‐double stranded <hi rend="fc">DNA</hi> and <hi rend="fc">C</hi>3. Steroid‐sparing effect of mycophenolate sodium was also evaluated.</p><head>Results</head><p>Mycophenolate sodium produced a significant reduction in <hi rend="fc">SLEDAI</hi> scores (<hi rend="italic">P </hi>< 0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ‐specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. No major adverse events were reported in this study.</p><head>Conclusion</head><p>Mycophenolate sodium is a safe alternative therapy in <hi rend="fc">SLE</hi> patients with extra‐renal involvement. The reduction in <hi rend="fc">SLEDAI</hi> scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non‐renal <hi rend="fc">SLE</hi> is warranted.</p></abstract><textClass><keywords><term xml:id="apl12179-kwd-0001">autoimmune</term><term xml:id="apl12179-kwd-0002">extra‐renal</term><term xml:id="apl12179-kwd-0003">immunosuppression</term><term xml:id="apl12179-kwd-0004">mycophenolate sodium</term><term xml:id="apl12179-kwd-0005"><hi rend="fc">SLEDAI</hi></term><term xml:id="apl12179-kwd-0006">systemic lupus erythematosus</term></keywords><keywords rend="articleCategory"><term>Original Article</term></keywords><keywords rend="tocHeading1"><term>Original articles</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc><revisionDesc><change when="2019-12-20" who="#istex" xml:id="pub2tei">formatting</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-ZX9ZQQC1-9/fulltext.txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component type="serialArticle" version="2.0" xml:id="apl12179" xml:lang="en"><header><publicationMeta level="product"><doi origin="wiley" registered="yes">10.1111/(ISSN)1756-185X</doi><issn type="print">1756-1841</issn><issn type="electronic">1756-185X</issn><idGroup><id type="product" value="APL"></id></idGroup><titleGroup><title sort="INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES" type="main">International Journal of Rheumatic Diseases</title><title type="short">Int J Rheum Dis</title></titleGroup></publicationMeta><publicationMeta level="part" position="60"><doi origin="wiley">10.1111/apl.2013.16.issue-6</doi><copyright ownership="publisher">International Journal of Rheumatic Diseases © 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd</copyright><numberingGroup><numbering type="journalVolume" number="16">16</numbering><numbering type="journalIssue">6</numbering></numberingGroup><coverDate startDate="2013-12">December 2013</coverDate></publicationMeta><publicationMeta level="unit" position="170" status="forIssue" type="article"><doi>10.1111/1756-185X.12179</doi><idGroup><id type="unit" value="APL12179"></id></idGroup><countGroup><count number="7" type="pageTotal"></count></countGroup><titleGroup><title type="articleCategory">Original Article</title><title type="tocHeading1">Original articles</title></titleGroup><copyright ownership="publisher">© 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd</copyright><eventGroup><event agent="SPS" date="2013-09-19" type="xmlCreated"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.2.8 mode:FullText" date="2013-12-31"></event><event type="publishedOnlineEarlyUnpaginated" date="2013-10-14"></event><event type="firstOnline" date="2013-10-14"></event><event type="publishedOnlineFinalForm" date="2013-12-31"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-02"></event></eventGroup><numberingGroup><numbering type="pageFirst">724</numbering><numbering type="pageLast">730</numbering></numberingGroup><correspondenceTo><lineatedText><line><i>Correspondence</i>: Dr Sargunan Sockalingam, Department of Medicine, Faculty of Medicine, University Malaya, Lembah Pantai, 50603 Kuala Lumpur, Malaysia.</line><line>Email: <email>sargunan@um.edu.my</email></line></lineatedText></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:APL.APL12179.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement</title><title type="shortAuthors">F. Yahya <i>et al</i>.</title></titleGroup><creators><creator affiliationRef="#apl12179-aff-0001" creatorRole="author" xml:id="apl12179-cr-0001"><personName><givenNames>Fariz</givenNames> <familyName>Yahya</familyName></personName></creator><creator affiliationRef="#apl12179-aff-0001" creatorRole="author" xml:id="apl12179-cr-0002"><personName><givenNames>Raja</givenNames> <familyName>Jasmin</familyName></personName></creator><creator affiliationRef="#apl12179-aff-0001" creatorRole="author" xml:id="apl12179-cr-0003"><personName><givenNames>Chin Teck</givenNames> <familyName>Ng</familyName></personName></creator><creator affiliationRef="#apl12179-aff-0001" creatorRole="author" xml:id="apl12179-cr-0004"><personName><givenNames>Tien Eang</givenNames> <familyName>Cheah</familyName></personName></creator><creator affiliationRef="#apl12179-aff-0001" corresponding="yes" creatorRole="author" xml:id="apl12179-cr-0005"><personName><givenNames>Sargunan</givenNames> <familyName>Sockalingam</familyName></personName></creator></creators><affiliationGroup><affiliation countryCode="MY" type="organization" xml:id="apl12179-aff-0001"><orgDiv>Division of Rheumatology</orgDiv> <orgDiv>Department of Medicine</orgDiv> <orgDiv>Faculty of Medicine</orgDiv> <orgName>University of Malaya</orgName> <address><city>Kuala Lumpur</city> <country>Malaysia</country></address></affiliation></affiliationGroup><keywordGroup type="author"><keyword xml:id="apl12179-kwd-0001">autoimmune</keyword><keyword xml:id="apl12179-kwd-0002">extra‐renal</keyword><keyword xml:id="apl12179-kwd-0003">immunosuppression</keyword><keyword xml:id="apl12179-kwd-0004">mycophenolate sodium</keyword><keyword xml:id="apl12179-kwd-0005"><fc>SLEDAI</fc></keyword><keyword xml:id="apl12179-kwd-0006">systemic lupus erythematosus</keyword></keywordGroup><fundingInfo><fundingAgency>Novartis</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:id="apl12179-abs-0001"><title type="main">Abstract</title><section xml:id="apl12179-sec-0001"><title type="main">Aim</title><p>Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (<fc>SLE</fc>) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra‐renal <fc>SLE</fc> involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra‐renal <fc>SLE</fc>.</p></section><section xml:id="apl12179-sec-0002"><title type="main">Methods</title><p>A total of 14 <fc>SLE</fc> patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included <fc>SLE D</fc>isease <fc>A</fc>ctivity <fc>I</fc>ndex (<fc>SLEDAI</fc>) score, other organ‐specific parameters and immunological parameters, including anti‐double stranded <fc>DNA</fc> and <fc>C</fc>3. Steroid‐sparing effect of mycophenolate sodium was also evaluated.</p></section><section xml:id="apl12179-sec-0003"><title type="main">Results</title><p>Mycophenolate sodium produced a significant reduction in <fc>SLEDAI</fc> scores (<i>P </i>< 0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ‐specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. No major adverse events were reported in this study.</p></section><section xml:id="apl12179-sec-0004"><title type="main">Conclusion</title><p>Mycophenolate sodium is a safe alternative therapy in <fc>SLE</fc> patients with extra‐renal involvement. The reduction in <fc>SLEDAI</fc> scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non‐renal <fc>SLE</fc> is warranted.</p></section></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement</title></titleInfo><name type="personal"><namePart type="given">Fariz</namePart><namePart type="family">Yahya</namePart><affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Raja</namePart><namePart type="family">Jasmin</namePart><affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Chin Teck</namePart><namePart type="family">Ng</namePart><affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Tien Eang</namePart><namePart type="family">Cheah</namePart><affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sargunan</namePart><namePart type="family">Sockalingam</namePart><affiliation>Division of Rheumatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia</affiliation><affiliation>: Dr Sargunan Sockalingam, Department of Medicine, Faculty of Medicine, University Malaya, Lembah Pantai, 50603 Kuala Lumpur, Malaysia.Email:</affiliation><affiliation>E-mail: sargunan@um.edu.my</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><dateIssued encoding="w3cdtf">2013-12</dateIssued><dateCreated encoding="w3cdtf">2013-09-19</dateCreated><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><abstract>Aim: Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (SLE) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra‐renal SLE involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra‐renal SLE. Methods: A total of 14 SLE patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included SLE Disease Activity Index (SLEDAI) score, other organ‐specific parameters and immunological parameters, including anti‐double stranded DNA and C3. Steroid‐sparing effect of mycophenolate sodium was also evaluated. Results: Mycophenolate sodium produced a significant reduction in SLEDAI scores (P < 0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ‐specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. No major adverse events were reported in this study. Conclusion: Mycophenolate sodium is a safe alternative therapy in SLE patients with extra‐renal involvement. The reduction in SLEDAI scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non‐renal SLE is warranted.</abstract><note type="funding">Novartis</note><subject><genre>keywords</genre><topic>autoimmune</topic><topic>extra‐renal</topic><topic>immunosuppression</topic><topic>mycophenolate sodium</topic><topic>SLEDAI</topic><topic>systemic lupus erythematosus</topic></subject><relatedItem type="host"><titleInfo><title>International Journal of Rheumatic Diseases</title></titleInfo><titleInfo type="abbreviated"><title>Int J Rheum Dis</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><genre>article-category</genre><topic>Original Article</topic><topic>Original articles</topic></subject><identifier type="ISSN">1756-1841</identifier><identifier type="eISSN">1756-185X</identifier><identifier type="DOI">10.1111/(ISSN)1756-185X</identifier><identifier type="PublisherID">APL</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>16</number></detail><detail type="issue"><caption>no.</caption><number>6</number></detail><extent unit="pages"><start>724</start><end>730</end><total>7</total></extent></part></relatedItem><relatedItem type="references" displayLabel="apl12179-cit-0001"><titleInfo><title>Clinical experience with mycophenolate mofetil in systemic autoimmune conditions refractory to common immunosuppressive therapies</title></titleInfo><name type="personal"><namePart type="given">C</namePart><namePart type="family">Bandelier</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">PA</namePart><namePart type="family">Guerne</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S</namePart><namePart type="family">Genevay</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A</namePart><namePart type="family">Finckh</namePart><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C</namePart><namePart type="family">Gabay</namePart><role><roleTerm type="text">author</roleTerm></role></name><genre>journal-article</genre><note type="citation/reference">Bandelier C, Guerne PA, Genevay S, Finckh A, Gabay C (2009) Clinical experience with mycophenolate mofetil in systemic autoimmune conditions refractory to common immunosuppressive therapies. 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Rheumatology (Oxford) 41, 876–82.</note><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>41</number></detail><extent unit="pages"><start>876</start><end>82</end></extent></part><relatedItem type="host"><titleInfo><title>Rheumatology (Oxford)</title></titleInfo><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>41</number></detail><extent unit="pages"><start>876</start><end>82</end></extent></part></relatedItem></relatedItem><identifier type="istex">5B414AF73A3A3C1212096C9A68A00CC923BEBDDD</identifier><identifier type="ark">ark:/67375/WNG-ZX9ZQQC1-9</identifier><identifier type="DOI">10.1111/1756-185X.12179</identifier><identifier type="ArticleID">APL12179</identifier><accessCondition type="use and reproduction" contentType="copyright">International Journal of Rheumatic Diseases © 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd© 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-L0C46X92-X">wiley</recordContentSource><recordOrigin>Converted from (version ) to MODS version 3.6.</recordOrigin><recordCreationDate encoding="w3cdtf">2019-11-13</recordCreationDate></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-ZX9ZQQC1-9/record.json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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