Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research
Identifieur interne : 002937 ( Istex/Corpus ); précédent : 002936; suivant : 002938Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research
Auteurs : C. Salliot ; D. Van Der HeijdeSource :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2009-07.
English descriptors
- Teeft :
- Adverse event, Adverse events, American college, Antirheumatic drugs, Arthritis, Arthritis rheum fries, Arthritis rheum kremer, Average dose, Cardiovascular diseases, Cardiovascular mortality, Cohort, Control groups, Cytopenia, Dmards, Dose methotrexate, Exclusion criteria, Folic, Folic acid, General population, Herpes zoster, Incidence rate, Incidence rates, Literature search, Liver damage, Liver enzymes, Liver toxicity, Lymphoma, Malignancy, Many patients experience, Methotrexate, Methotrexate therapy, Methotrexate treatment, Monotherapy, Online, Other dmards, Permanent discontinuation, Predefined inclusion, Prospective studies, Prospective study, Rheum, Rheumatoid, Rheumatoid arthritis, Rheumatoid arthritis patients, Rheumatol, Rheumatol weinblatt, Risk factor, Sequential liver biopsies, Serious infections, Severe fibrosis, Side effects, Study design, Supplemental table, Survival benefit, Systematic literature research, Systematic literature search, Total number, Toxicity, Toxicity index, Upper limit.
Abstract
Objective: To perform a systematic literature review of the long-term safety of methotrexate (MTX) monotherapy in rheumatoid arthritis (RA). Methods: A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied. Results: 88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4). Conclusion: This systematic literature search on MTX monotherapy with relatively low-dose use during at least 2 years shows favourable long-term safety.
Url:
DOI: 10.1136/ard.2008.093690
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ISTEX:AB0810715F428BD5BC475ADD462ACEA05CF41C88Le document en format XML
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Methods: A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied. Results: 88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4). 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Methods: A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied. Results: 88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4). 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sciences medicales</json:string></inist></categories><publicationDate>2009</publicationDate><copyrightDate>2009</copyrightDate><doi><json:string>10.1136/ard.2008.093690</json:string></doi><id>AB0810715F428BD5BC475ADD462ACEA05CF41C88</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/ark:/67375/NVC-G24F8K5X-3/fulltext.pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/ark:/67375/NVC-G24F8K5X-3/bundle.zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/ark:/67375/NVC-G24F8K5X-3/fulltext.tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher scheme="https://publisher-list.data.istex.fr">BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><availability status="free"><p>Open Access</p></availability><date>2008-12-05</date></publicationStmt><notesStmt><note type="research-article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</note><note type="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note><note>Additional tables, figure and references are published online only at http://ard.bmj.com/content/vol68/issue7</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research</title><author xml:id="author-0000"><persName><forename type="first">C</forename><surname>Salliot</surname></persName><affiliation>Paris Descartes University, Medicine Faculty, Rheumatology B Department, Cochin Hospital, Paris, France</affiliation></author><author xml:id="author-0001"><persName><forename type="first">D</forename><surname>van der Heijde</surname></persName><affiliation>Rheumatology Department, Leiden University Medical Centre, Leiden, The Netherlands</affiliation></author><idno type="istex">AB0810715F428BD5BC475ADD462ACEA05CF41C88</idno><idno type="ark">ark:/67375/NVC-G24F8K5X-3</idno><idno type="DOI">10.1136/ard.2008.093690</idno><idno type="href">annrheumdis-68-1100.pdf</idno><idno type="article-id">ar93690</idno><idno type="PMID">19060002</idno><idno type="local">annrheumdis;68/7/1100</idno></analytic><monogr><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="pISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><idno type="publisher-id">ard</idno><idno type="PublisherID-hwp">annrheumdis</idno><idno type="PublisherID-nlm-ta">Ann Rheum Dis</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2009-07"></date><biblScope unit="volume">68</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="1100">1100</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2008-12-05</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Objective: To perform a systematic literature review of the long-term safety of methotrexate (MTX) monotherapy in rheumatoid arthritis (RA). Methods: A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied. Results: 88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4). Conclusion: This systematic literature search on MTX monotherapy with relatively low-dose use during at least 2 years shows favourable long-term safety.</p></abstract><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Unlocked</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Immunology (including allergy)</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Pathology</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Radiology</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>hwp-journal-coll</head><item><term>Connective tissue disease</term></item></list></keywords></textClass><textClass><keywords scheme="Journal 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Dis</abbrev-journal-title><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">ar93690</article-id><article-id pub-id-type="doi">10.1136/ard.2008.093690</article-id><article-id pub-id-type="other">annrheumdis;68/7/1100</article-id><article-id pub-id-type="other">annrheumdis;ard.2008.093690</article-id><article-id pub-id-type="pmid">19060002</article-id><article-id pub-id-type="other">1100</article-id><article-id pub-id-type="other">ard.2008.093690</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical and epidemiological research</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Unlocked</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Immunology (including allergy)</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Pathology</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Radiology</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Connective tissue disease</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Degenerative joint disease</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Musculoskeletal syndromes</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Rheumatoid arthritis</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Surgical diagnostic tests</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Clinical diagnostic tests</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Epidemiology</subject></subj-group></article-categories><title-group><article-title>Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research</article-title><alt-title alt-title-type="running-head">Extended report</alt-title></title-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Salliot</surname><given-names>C</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>van der Heijde</surname><given-names>D</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>Paris Descartes University, Medicine Faculty, Rheumatology B Department, Cochin Hospital, Paris, France</addr-line></aff><aff id="aff2"><label>2</label><addr-line>Rheumatology Department, Leiden University Medical Centre, Leiden, The Netherlands</addr-line></aff><author-notes><corresp>Dr C Salliot, Hôpital Cochin, service de Rhumatologie B, rue du faubourg Saint-Jacques, 75014 Paris, France; <email xlink:type="simple">carinesalliot@gmail.com</email></corresp><fn fn-type="other"><p>Additional tables, figure and references are published online only at <ext-link ext-link-type="uri" xlink:href="http://ard.bmj.com/content/vol68/issue7" xlink:type="simple">http://ard.bmj.com/content/vol68/issue7</ext-link></p></fn></author-notes><pub-date pub-type="collection"><year>2009</year></pub-date><pub-date pub-type="ppub"><month>7</month><year>2009</year></pub-date><pub-date pub-type="epub-original"><day>5</day><month>12</month><year>2008</year></pub-date><pub-date pub-type="epub"><day>5</day><month>12</month><year>2008</year></pub-date><volume>68</volume><volume-id pub-id-type="other">68</volume-id><volume-id pub-id-type="other">68</volume-id><issue>7</issue><issue-id pub-id-type="other">annrheumdis;68/7</issue-id><issue-id pub-id-type="other">7</issue-id><issue-id pub-id-type="other">68/7</issue-id><fpage>1100</fpage><history><date date-type="accepted"><day>17</day><month>11</month><year>2008</year></date></history><permissions><copyright-statement>© Salliot et al 2009</copyright-statement><copyright-year>2009</copyright-year><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0/" xlink:type="simple"><p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p></license></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="annrheumdis-68-1100.pdf"></self-uri><abstract><sec><title>Objective:</title><p>To perform a systematic literature review of the long-term safety of methotrexate (MTX) monotherapy in rheumatoid arthritis (RA).</p></sec><sec><title>Methods:</title><p>A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied.</p></sec><sec><title>Results:</title><p>88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, <sc>d</sc>-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4).</p></sec><sec><title>Conclusion:</title><p>This systematic literature search on MTX monotherapy with relatively low-dose use during at least 2 years shows favourable long-term safety.</p></sec></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research</title></titleInfo><name type="personal"><namePart type="given">C</namePart><namePart type="family">Salliot</namePart><affiliation>Paris Descartes University, Medicine Faculty, Rheumatology B Department, Cochin Hospital, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D</namePart><namePart type="family">van der Heijde</namePart><affiliation>Rheumatology Department, Leiden University Medical Centre, Leiden, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</genre><originInfo><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><dateIssued encoding="w3cdtf">2009-07</dateIssued><dateCreated encoding="w3cdtf">2008-12-05</dateCreated><copyrightDate encoding="w3cdtf">2009</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract>Objective: To perform a systematic literature review of the long-term safety of methotrexate (MTX) monotherapy in rheumatoid arthritis (RA). Methods: A search was performed in Medline, Cochrane and EMBASE. Adults with RA who had received MTX monotherapy for more than 2 years were studied. Results: 88 published studies were included. Over 12 years of treatment, the termination rate of MTX due to toxicity was less than for sulfasalazine, gold, d-penicillamine and higher than for hydroxychloroquine (level of evidence 2a–2b). Long-term use of MTX does not appear to be a risk factor for serious infections, including herpes zoster (2b–4), and could provide a survival benefit by reducing cardiovascular mortality (2b). The prevalence of raised liver enzymes (more than twice the upper limit of normal) is close to 13% of patients; 3.7% of patients stopped MTX permanently owing to liver toxicity (2b). Data on the risk for liver fibrosis/cirrhosis are conflicting: a meta-analysis showed an incidence of fibrosis of 2.7% after 4 years of MTX (2a). However, two other studies on sequential liver biopsies did not show evidence for developing severe damage (2b). Insufficient data are available to fully assess the risk of lymphoma and malignancies, although there is no strong evidence of increased risk (2b–4). Conclusion: This systematic literature search on MTX monotherapy with relatively low-dose use during at least 2 years shows favourable long-term safety.</abstract><note type="footnotes">Additional tables, figure and references are published online only at http://ard.bmj.com/content/vol68/issue7</note><relatedItem type="host"><titleInfo><title>Annals of the Rheumatic Diseases</title></titleInfo><titleInfo type="abbreviated"><title>Ann 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>hwp-journal-coll</genre><topic>Unlocked</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Immunology (including allergy)</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Pathology</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Radiology</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Connective tissue disease</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Degenerative joint disease</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Musculoskeletal syndromes</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Rheumatoid arthritis</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Surgical diagnostic tests</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Clinical diagnostic tests</topic></subject><subject><genre>hwp-journal-coll</genre><topic>Epidemiology</topic></subject><identifier type="ISSN">0003-4967</identifier><identifier type="eISSN">1468-2060</identifier><identifier type="PublisherID">ard</identifier><identifier type="PublisherID-hwp">annrheumdis</identifier><identifier type="PublisherID-nlm-ta">Ann Rheum Dis</identifier><part><date>2009</date><detail type="volume"><caption>vol.</caption><number>68</number></detail><detail type="issue"><caption>no.</caption><number>7</number></detail><extent unit="pages"><start>1100</start></extent></part></relatedItem><identifier type="istex">AB0810715F428BD5BC475ADD462ACEA05CF41C88</identifier><identifier type="ark">ark:/67375/NVC-G24F8K5X-3</identifier><identifier type="DOI">10.1136/ard.2008.093690</identifier><identifier type="href">annrheumdis-68-1100.pdf</identifier><identifier type="ArticleID">ar93690</identifier><identifier type="PMID">19060002</identifier><identifier type="local">annrheumdis;68/7/1100</identifier><accessCondition type="use and reproduction" contentType="open-access">This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-7M42M2QJ-2">bmj</recordContentSource><recordOrigin>© Salliot et al 2009</recordOrigin></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/NVC-G24F8K5X-3/record.json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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