Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: Evolving role of biologic therapies
Identifieur interne : 000345 ( Istex/Corpus ); précédent : 000344; suivant : 000346Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: Evolving role of biologic therapies
Auteurs : Eamonn S. Molloy ; Leonard H. CalabreseSource :
- Arthritis & Rheumatism [ 0004-3591 ] ; 2012-09.
English descriptors
- Teeft :
- Aers, Aers database, Alkylating agent, Antiviral drugs, Ards, Arthritis rheum, Autoimmune, Biologic, Biologic agent, Biologic agents, Biologic therapies, Biopsy, Brain biopsy, Calabrese, Contrast enhancement, Cryoglobulinemic vasculitis, Database, Dermatomyositis, Drug administration, Erythematosus, Further analysis, Immunosuppressive, Immunosuppressive agents, Immunosuppressive therapy, Important drug warning, Inflammatory, Infliximab, Ivig, Last dose, Leukoencephalopathy, Lupus, Lymphoma, Lymphopenia, Magnetic resonance imaging, Medwatch forms, Mirt, Molloy, Multifocal, Mycophenolate mofetil, Natalizumab, Organ transplantation, Potential confounders, Progressive multifocal leukoencephalopathy, Rheumatic, Rheumatic diseases, Rheumatoid, Rheumatoid arthritis, Rheumatoid vasculitis, Risk factors, Rituximab, Systemic lupus erythematosus, Transplantation, Vasculitis.
Abstract
Objective: To evaluate the association of progressive multifocal leukoencephalopathy (PML) with immunosuppressive therapy for autoimmune rheumatic diseases (ARDs). Methods: A Freedom of Information Act request was submitted for all cases of PML within the Food and Drug Administration Adverse Event Reporting System database. ARD cases were selected for further analysis. Results: A total of 34 confirmed cases of PML in the setting of ARDs were identified: 17 had systemic lupus erythematosus, 10 had rheumatoid arthritis, 4 had vasculitis, and 3 had dermatomyositis. Fifteen of these patients were treated with one or more biologic agents: 14 received rituximab (RTX), 6 received anti–tumor necrosis factor (anti‐TNF) therapy (5 treated with anti‐TNF agent prior to RTX). Four RTX‐treated patients were not receiving additional immunosuppressive therapy at the time of PML onset, other than an antimalarial drug and/or low‐dose glucocorticoids; all others who were receiving a biologic agent were also receiving one or more synthetic disease‐modifying agents. All but 1 patient receiving a biologic agent had at least 1 potential confounding factor for the diagnosis of PML. The remaining 19 confirmed cases of PML among ARD patients were treated with synthetic disease‐modifying antirheumatic drugs only, 14 of whom had received an alkylating agent. Conclusion: PML has been reported in patients with ARD treated with various immunosuppressive agents. The limitations of this study preclude definitive attribution of causality. While the paucity of confirmed cases recently exposed to anti‐TNF therapy suggests a causal relationship is unlikely, a specific signal is emerging with regard to rituximab and PML. Although this is a rare adverse event associated with RTX therapy, the devastating nature of PML mandates continued vigilance, particularly in patients with current or prior exposure to an alkylating agent.
Url:
DOI: 10.1002/art.34468
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ISTEX:3B8F75CB9F9E7EA1F98B6CAE895BD2989C4D7DC1Le document en format XML
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Methods: A Freedom of Information Act request was submitted for all cases of PML within the Food and Drug Administration Adverse Event Reporting System database. ARD cases were selected for further analysis. Results: A total of 34 confirmed cases of PML in the setting of ARDs were identified: 17 had systemic lupus erythematosus, 10 had rheumatoid arthritis, 4 had vasculitis, and 3 had dermatomyositis. Fifteen of these patients were treated with one or more biologic agents: 14 received rituximab (RTX), 6 received anti–tumor necrosis factor (anti‐TNF) therapy (5 treated with anti‐TNF agent prior to RTX). Four RTX‐treated patients were not receiving additional immunosuppressive therapy at the time of PML onset, other than an antimalarial drug and/or low‐dose glucocorticoids; all others who were receiving a biologic agent were also receiving one or more synthetic disease‐modifying agents. All but 1 patient receiving a biologic agent had at least 1 potential confounding factor for the diagnosis of PML. The remaining 19 confirmed cases of PML among ARD patients were treated with synthetic disease‐modifying antirheumatic drugs only, 14 of whom had received an alkylating agent. Conclusion: PML has been reported in patients with ARD treated with various immunosuppressive agents. The limitations of this study preclude definitive attribution of causality. While the paucity of confirmed cases recently exposed to anti‐TNF therapy suggests a causal relationship is unlikely, a specific signal is emerging with regard to rituximab and PML. Although this is a rare adverse event associated with RTX therapy, the devastating nature of PML mandates continued vigilance, particularly in patients with current or prior exposure to an alkylating agent.</div></front></TEI><istex><corpusName>wiley</corpusName><keywords><teeft><json:string>multifocal</json:string><json:string>leukoencephalopathy</json:string><json:string>immunosuppressive</json:string><json:string>ards</json:string><json:string>progressive multifocal leukoencephalopathy</json:string><json:string>rituximab</json:string><json:string>molloy</json:string><json:string>calabrese</json:string><json:string>autoimmune</json:string><json:string>rheumatoid</json:string><json:string>lymphopenia</json:string><json:string>vasculitis</json:string><json:string>database</json:string><json:string>lupus</json:string><json:string>transplantation</json:string><json:string>rheumatic diseases</json:string><json:string>biologic</json:string><json:string>systemic lupus erythematosus</json:string><json:string>erythematosus</json:string><json:string>immunosuppressive therapy</json:string><json:string>immunosuppressive agents</json:string><json:string>infliximab</json:string><json:string>aers</json:string><json:string>dermatomyositis</json:string><json:string>biologic agents</json:string><json:string>mirt</json:string><json:string>rheumatoid arthritis</json:string><json:string>natalizumab</json:string><json:string>ivig</json:string><json:string>brain biopsy</json:string><json:string>aers database</json:string><json:string>drug administration</json:string><json:string>mycophenolate mofetil</json:string><json:string>last dose</json:string><json:string>medwatch forms</json:string><json:string>biologic therapies</json:string><json:string>rheumatoid vasculitis</json:string><json:string>arthritis rheum</json:string><json:string>alkylating agent</json:string><json:string>contrast enhancement</json:string><json:string>inflammatory</json:string><json:string>biopsy</json:string><json:string>lymphoma</json:string><json:string>cryoglobulinemic vasculitis</json:string><json:string>risk factors</json:string><json:string>important drug warning</json:string><json:string>antiviral drugs</json:string><json:string>magnetic resonance imaging</json:string><json:string>biologic agent</json:string><json:string>organ transplantation</json:string><json:string>potential confounders</json:string><json:string>further analysis</json:string><json:string>rheumatic</json:string></teeft></keywords><author><json:item><name>Eamonn S. Molloy</name><affiliations><json:string>St. Vincent's University Hospital, Elm Park, Dublin, Ireland</json:string><json:string>E-mail: e.molloy@svuh.ie</json:string><json:string>Correspondence address: Department of Rheumatology, St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland</json:string></affiliations></json:item><json:item><name>Leonard H. Calabrese</name><affiliations><json:string>Cleveland Clinic Foundation, Cleveland, Ohio</json:string></affiliations></json:item></author><articleId><json:string>ART34468</json:string></articleId><arkIstex>ark:/67375/WNG-GVWTS5LV-W</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>Objective: To evaluate the association of progressive multifocal leukoencephalopathy (PML) with immunosuppressive therapy for autoimmune rheumatic diseases (ARDs). Methods: A Freedom of Information Act request was submitted for all cases of PML within the Food and Drug Administration Adverse Event Reporting System database. ARD cases were selected for further analysis. Results: A total of 34 confirmed cases of PML in the setting of ARDs were identified: 17 had systemic lupus erythematosus, 10 had rheumatoid arthritis, 4 had vasculitis, and 3 had dermatomyositis. Fifteen of these patients were treated with one or more biologic agents: 14 received rituximab (RTX), 6 received anti–tumor necrosis factor (anti‐TNF) therapy (5 treated with anti‐TNF agent prior to RTX). Four RTX‐treated patients were not receiving additional immunosuppressive therapy at the time of PML onset, other than an antimalarial drug and/or low‐dose glucocorticoids; all others who were receiving a biologic agent were also receiving one or more synthetic disease‐modifying agents. All but 1 patient receiving a biologic agent had at least 1 potential confounding factor for the diagnosis of PML. The remaining 19 confirmed cases of PML among ARD patients were treated with synthetic disease‐modifying antirheumatic drugs only, 14 of whom had received an alkylating agent. Conclusion: PML has been reported in patients with ARD treated with various immunosuppressive agents. The limitations of this study preclude definitive attribution of causality. While the paucity of confirmed cases recently exposed to anti‐TNF therapy suggests a causal relationship is unlikely, a specific signal is emerging with regard to rituximab and PML. Although this is a rare adverse event associated with RTX therapy, the devastating nature of PML mandates continued vigilance, particularly in patients with current or prior exposure to an alkylating agent.</abstract><qualityIndicators><score>9.814</score><pdfWordCount>4814</pdfWordCount><pdfCharCount>32647</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>9</pdfPageCount><pdfPageSize>612 x 792 pts (letter)</pdfPageSize><pdfWordsPerPage>535</pdfWordsPerPage><pdfText>true</pdfText><refBibsNative>true</refBibsNative><abstractWordCount>282</abstractWordCount><abstractCharCount>1919</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: Evolving role of biologic therapies</title><pmid><json:string>22422012</json:string></pmid><genre><json:string>article</json:string></genre><host><title>Arthritis & Rheumatism</title><language><json:string>unknown</json:string></language><doi><json:string>10.1002/(ISSN)1529-0131</json:string></doi><issn><json:string>0004-3591</json:string></issn><eissn><json:string>1529-0131</json:string></eissn><publisherId><json:string>ART</json:string></publisherId><volume>64</volume><issue>9</issue><pages><first>3043</first><last>3051</last><total>9</total></pages><genre><json:string>journal</json:string></genre><subject><json:item><value>Infection</value></json:item><json:item><value>Infection</value></json:item></subject></host><namedEntities><unitex><date><json:string>2009</json:string><json:string>2012</json:string><json:string>2010</json:string></date><geogName></geogName><orgName><json:string>US Food and Drug Administration</json:string><json:string>Genentech</json:string><json:string>Centocor Inc.</json:string><json:string>University Hospital, Elm Park, Dublin</json:string><json:string>Department of Rheumatology, St</json:string><json:string>Cleveland Clinic Foundation, Cleveland, Ohio</json:string><json:string>University Hospital, Elm Park, Dublin, Ireland</json:string><json:string>European Medicines Agency</json:string><json:string>Abbott Laboratories</json:string><json:string>World Health Organization</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>Calabrese</json:string><json:string>Molloy</json:string><json:string>Leonard H. 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Molloy</json:string><json:string>Eamonn Molloy</json:string></persName><placeName><json:string>Bristol</json:string><json:string>Ireland</json:string></placeName><ref_url></ref_url><ref_bibl><json:string>[4]</json:string><json:string>Tuccori et al</json:string><json:string>[3]</json:string><json:string>[5]</json:string><json:string>October 2010</json:string></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/WNG-GVWTS5LV-W</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 - Pharmacology (medical)</json:string><json:string>1 - Life Sciences</json:string><json:string>2 - Immunology and Microbiology</json:string><json:string>3 - Immunology</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Rheumatology</json:string><json:string>1 - 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Four RTX‐treated patients were not receiving additional immunosuppressive therapy at the time of PML onset, other than an antimalarial drug and/or low‐dose glucocorticoids; all others who were receiving a biologic agent were also receiving one or more synthetic disease‐modifying agents. All but 1 patient receiving a biologic agent had at least 1 potential confounding factor for the diagnosis of PML. The remaining 19 confirmed cases of PML among ARD patients were treated with synthetic disease‐modifying antirheumatic drugs only, 14 of whom had received an alkylating agent.</p><head>Conclusion</head><p>PML has been reported in patients with ARD treated with various immunosuppressive agents. The limitations of this study preclude definitive attribution of causality. While the paucity of confirmed cases recently exposed to anti‐TNF therapy suggests a causal relationship is unlikely, a specific signal is emerging with regard to rituximab and PML. 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registered="yes">10.1002/art.34468</doi><idGroup><id type="unit" value="ART34468"></id></idGroup><countGroup><count type="pageTotal" number="9"></count></countGroup><titleGroup><title type="articleCategory">Infection</title><title type="tocHeading1">Infection</title></titleGroup><copyright ownership="thirdParty">Copyright © 2012 by the American College of Rheumatology</copyright><eventGroup><event type="manuscriptReceived" date="2011-09-19"></event><event type="manuscriptAccepted" date="2012-03-06"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:3.1.9 mode:FullText" date="2012-10-18"></event><event type="publishedOnlineAccepted" date="2012-03-15"></event><event type="publishedOnlineFinalForm" date="2012-08-27"></event><event type="firstOnline" date="2012-08-27"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-01-05"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.3.7 mode:FullText" date="2015-03-24"></event></eventGroup><numberingGroup><numbering type="pageFirst">3043</numbering><numbering type="pageLast">3051</numbering></numberingGroup><correspondenceTo>Department of Rheumatology, St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:ART.ART34468.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="0"></count><count type="tableTotal" number="4"></count><count type="referenceTotal" number="20"></count><count type="wordTotal" number="6162"></count></countGroup><titleGroup><title type="main" xml:lang="en">Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: Evolving role of biologic therapies</title><title type="short" xml:lang="en">PML and Biologic Therapies in Rheumatic Diseases</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes" noteRef="#fn1"><personName><givenNames>Eamonn S.</givenNames><familyName>Molloy</familyName></personName><contactDetails><email>e.molloy@svuh.ie</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2" noteRef="#fn2"><personName><givenNames>Leonard H.</givenNames><familyName>Calabrese</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="IE" type="organization"><unparsedAffiliation>St. Vincent's University Hospital, Elm Park, Dublin, Ireland</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Cleveland Clinic Foundation, Cleveland, Ohio</unparsedAffiliation></affiliation></affiliationGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><section xml:id="abs1-1"><title type="main">Objective</title><p>To evaluate the association of progressive multifocal leukoencephalopathy (PML) with immunosuppressive therapy for autoimmune rheumatic diseases (ARDs).</p></section><section xml:id="abs1-2"><title type="main">Methods</title><p>A Freedom of Information Act request was submitted for all cases of PML within the Food and Drug Administration Adverse Event Reporting System database. ARD cases were selected for further analysis.</p></section><section xml:id="abs1-3"><title type="main">Results</title><p>A total of 34 confirmed cases of PML in the setting of ARDs were identified: 17 had systemic lupus erythematosus, 10 had rheumatoid arthritis, 4 had vasculitis, and 3 had dermatomyositis. Fifteen of these patients were treated with one or more biologic agents: 14 received rituximab (RTX), 6 received anti–tumor necrosis factor (anti‐TNF) therapy (5 treated with anti‐TNF agent prior to RTX). Four RTX‐treated patients were not receiving additional immunosuppressive therapy at the time of PML onset, other than an antimalarial drug and/or low‐dose glucocorticoids; all others who were receiving a biologic agent were also receiving one or more synthetic disease‐modifying agents. All but 1 patient receiving a biologic agent had at least 1 potential confounding factor for the diagnosis of PML. The remaining 19 confirmed cases of PML among ARD patients were treated with synthetic disease‐modifying antirheumatic drugs only, 14 of whom had received an alkylating agent.</p></section><section xml:id="abs1-4"><title type="main">Conclusion</title><p>PML has been reported in patients with ARD treated with various immunosuppressive agents. The limitations of this study preclude definitive attribution of causality. While the paucity of confirmed cases recently exposed to anti‐TNF therapy suggests a causal relationship is unlikely, a specific signal is emerging with regard to rituximab and PML. Although this is a rare adverse event associated with RTX therapy, the devastating nature of PML mandates continued vigilance, particularly in patients with current or prior exposure to an alkylating agent.</p></section></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>Dr. Molloy has received speaking fees from Bristol‐Myers Squibb, MSD, Abbott Laboratories, and Roche, and honoraria for Advisory Board service from GlaxoSmithKline and Roche (less than $10,000 each).</p></note><note xml:id="fn2"><p>Dr. Calabrese has received consulting fees and speaking fees from Roche, Pfizer, Amgen, Bristol‐Myers Squibb, and Centocor (less than $10,000 each) and from Genentech (more than $10,000).</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: Evolving role of biologic therapies</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>PML and Biologic Therapies in Rheumatic Diseases</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: Evolving role of biologic therapies</title></titleInfo><name type="personal"><namePart type="given">Eamonn S.</namePart><namePart type="family">Molloy</namePart><affiliation>St. Vincent's University Hospital, Elm Park, Dublin, Ireland</affiliation><description>Dr. Molloy has received speaking fees from Bristol‐Myers Squibb, MSD, Abbott Laboratories, and Roche, and honoraria for Advisory Board service from GlaxoSmithKline and Roche (less than $10,000 each).</description><affiliation>E-mail: e.molloy@svuh.ie</affiliation><affiliation>Correspondence address: Department of Rheumatology, St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Leonard H.</namePart><namePart type="family">Calabrese</namePart><affiliation>Cleveland Clinic Foundation, Cleveland, Ohio</affiliation><description>Dr. Calabrese has received consulting fees and speaking fees from Roche, Pfizer, Amgen, Bristol‐Myers Squibb, and Centocor (less than $10,000 each) and from Genentech (more than $10,000).</description><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>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2012-09</dateIssued><dateCaptured encoding="w3cdtf">2011-09-19</dateCaptured><dateValid encoding="w3cdtf">2012-03-06</dateValid><copyrightDate encoding="w3cdtf">2012</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">0</extent><extent unit="tables">4</extent><extent unit="references">20</extent><extent unit="words">6162</extent></physicalDescription><abstract lang="en">Objective: To evaluate the association of progressive multifocal leukoencephalopathy (PML) with immunosuppressive therapy for autoimmune rheumatic diseases (ARDs). Methods: A Freedom of Information Act request was submitted for all cases of PML within the Food and Drug Administration Adverse Event Reporting System database. ARD cases were selected for further analysis. Results: A total of 34 confirmed cases of PML in the setting of ARDs were identified: 17 had systemic lupus erythematosus, 10 had rheumatoid arthritis, 4 had vasculitis, and 3 had dermatomyositis. Fifteen of these patients were treated with one or more biologic agents: 14 received rituximab (RTX), 6 received anti–tumor necrosis factor (anti‐TNF) therapy (5 treated with anti‐TNF agent prior to RTX). Four RTX‐treated patients were not receiving additional immunosuppressive therapy at the time of PML onset, other than an antimalarial drug and/or low‐dose glucocorticoids; all others who were receiving a biologic agent were also receiving one or more synthetic disease‐modifying agents. All but 1 patient receiving a biologic agent had at least 1 potential confounding factor for the diagnosis of PML. The remaining 19 confirmed cases of PML among ARD patients were treated with synthetic disease‐modifying antirheumatic drugs only, 14 of whom had received an alkylating agent. Conclusion: PML has been reported in patients with ARD treated with various immunosuppressive agents. The limitations of this study preclude definitive attribution of causality. While the paucity of confirmed cases recently exposed to anti‐TNF therapy suggests a causal relationship is unlikely, a specific signal is emerging with regard to rituximab and PML. 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