Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis
Identifieur interne : 000099 ( Istex/Corpus ); précédent : 000098; suivant : 000100Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis
Auteurs : S. Ten Wolde ; F. C. Breedveld ; B. A. C. Dijkmans ; J. Hermans ; J. P. Vandenbroucke ; M. A. F. J. Van De Laar ; H. M. Markusse ; M. Janssen ; H. R. Van Den BrinkSource :
- The Lancet [ 0140-6736 ] ; 1996.
English descriptors
- Teeft :
- Active movement, Arthritis, Arthritis rheum, Articular, Articular index, Azathioprine, Baseline, Baseline characteristics, Chloroquine, Clin rheumatol, Clinical trial, Continuedtreatment group, Continuous therapy, Cumulative incidence, Daily dose, Discontinuation, Disease activity, Disease activity indices, Disease characteristics, Drug group, Exclusion criteria, Flare, Flare patients, Flare rate, Foot radiographs, Gastrointestinal complaints, Gold therapy, Grip strength, High maintenance dose, Hospital pharmacy, Hydroxychloroquine, Independent committee, Joint tenderness, Kennemer gasthuis location, Laboratory tests, Logistic regression model, Longterm treatment, Medication, Methotrexate, Methotrexate therapy, Mild flare, More flares, Morning stiffness, Nsaid, Parenteral, Parenteral gold, Placebo, Placebo group, Placebo tablets, Present study, Protocol, Protocol medication, Randomisation, Randomised, Remission, Rheum, Rheumatoid, Rheumatoid arthritis, Rheumatoid factor, Rheumatoid flare, Rheumatol, Risk factors, Second line therapy, Serum creatinine, Serum gold concentrations, Severe flare, Severe flares, Significant risk factor, Soft tissue, Statistical analysis, Study centres, Sulphasalazine, Swollen joints, Treatment group, Treatment groups, Trial medication, University hospital leiden.
Abstract
Abstract: SummaryBackground A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.Methods A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n=142) or received a placebo (n=143). The endpoint was a flare, defined as recurrence of synovitis.Findings At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p=0·002). The risk of a flare was 2·0 times higher for patients receiving placebo than for those continuing the second-line drug (95% Cl 1·27 to 3·17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.Interpretation Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.
Url:
DOI: 10.1016/S0140-6736(96)90535-8
Links to Exploration step
ISTEX:03F637C3AFE50B8ED82EAE153E91E46760717FC9Le document en format XML
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Vandenbroucke</name><affiliation><mods:affiliation>Department of Clinical Epidemiology, University Hospital, Leiden, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Van De Laar, M A F J" sort="Van De Laar, M A F J" uniqKey="Van De Laar M" first="M. A. F. J." last="Van De Laar">M. A. F. J. Van De Laar</name><affiliation><mods:affiliation>Department of Rheumatology of Medisch Spectrum Twente, Enschede, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Markusse, H M" sort="Markusse, H M" uniqKey="Markusse H" first="H. M." last="Markusse">H. M. Markusse</name><affiliation><mods:affiliation>Dr Daniel den Hoed Kliniek Rotterdam, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Janssen, M" sort="Janssen, M" uniqKey="Janssen M" first="M." last="Janssen">M. 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Ten Wolde</name><affiliation><mods:affiliation>Department of Rheumatology, University Hospital, Leiden, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Breedveld, F C" sort="Breedveld, F C" uniqKey="Breedveld F" first="F. C." last="Breedveld">F. C. Breedveld</name><affiliation><mods:affiliation>Department of Rheumatology, University Hospital, Leiden, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Dijkmans, B A C" sort="Dijkmans, B A C" uniqKey="Dijkmans B" first="B. A. C." last="Dijkmans">B. A. C. Dijkmans</name><affiliation><mods:affiliation>Correspondence to: Dr B A C Dijkmans, Department of Rheumatology, University Hospital Leiden, Building 1, C4R, PO Box 9600, 2300 RC Leiden, Netherlands</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Rheumatology, University Hospital, Leiden, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Hermans, J" sort="Hermans, J" uniqKey="Hermans J" first="J." last="Hermans">J. Hermans</name><affiliation><mods:affiliation>Department of Medical Statistics, University Hospital, Leiden, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Vandenbroucke, J P" sort="Vandenbroucke, J P" uniqKey="Vandenbroucke J" first="J. P." last="Vandenbroucke">J. P. Vandenbroucke</name><affiliation><mods:affiliation>Department of Clinical Epidemiology, University Hospital, Leiden, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Van De Laar, M A F J" sort="Van De Laar, M A F J" uniqKey="Van De Laar M" first="M. A. F. J." last="Van De Laar">M. A. F. J. Van De Laar</name><affiliation><mods:affiliation>Department of Rheumatology of Medisch Spectrum Twente, Enschede, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Markusse, H M" sort="Markusse, H M" uniqKey="Markusse H" first="H. M." last="Markusse">H. M. Markusse</name><affiliation><mods:affiliation>Dr Daniel den Hoed Kliniek Rotterdam, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Janssen, M" sort="Janssen, M" uniqKey="Janssen M" first="M." last="Janssen">M. Janssen</name><affiliation><mods:affiliation>Ziekenhuis Rijnstate, Arnhem, Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Van Den Brink, H R" sort="Van Den Brink, H R" uniqKey="Van Den Brink H" first="H. R." last="Van Den Brink">H. R. Van Den Brink</name><affiliation><mods:affiliation>Medisch Centrum Alkmaar Alkmaar, Netherlands</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">The Lancet</title><title level="j" type="abbrev">LANCET</title><idno type="ISSN">0140-6736</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1996">1996</date><biblScope unit="volume">347</biblScope><biblScope unit="issue">8998</biblScope><biblScope unit="page" from="347">347</biblScope><biblScope unit="page" to="352">352</biblScope></imprint><idno type="ISSN">0140-6736</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0140-6736</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Active movement</term><term>Arthritis</term><term>Arthritis rheum</term><term>Articular</term><term>Articular index</term><term>Azathioprine</term><term>Baseline</term><term>Baseline characteristics</term><term>Chloroquine</term><term>Clin rheumatol</term><term>Clinical trial</term><term>Continuedtreatment group</term><term>Continuous therapy</term><term>Cumulative incidence</term><term>Daily dose</term><term>Discontinuation</term><term>Disease activity</term><term>Disease activity indices</term><term>Disease characteristics</term><term>Drug group</term><term>Exclusion criteria</term><term>Flare</term><term>Flare patients</term><term>Flare rate</term><term>Foot radiographs</term><term>Gastrointestinal complaints</term><term>Gold therapy</term><term>Grip strength</term><term>High maintenance dose</term><term>Hospital pharmacy</term><term>Hydroxychloroquine</term><term>Independent committee</term><term>Joint tenderness</term><term>Kennemer gasthuis location</term><term>Laboratory tests</term><term>Logistic regression model</term><term>Longterm treatment</term><term>Medication</term><term>Methotrexate</term><term>Methotrexate therapy</term><term>Mild flare</term><term>More flares</term><term>Morning stiffness</term><term>Nsaid</term><term>Parenteral</term><term>Parenteral gold</term><term>Placebo</term><term>Placebo group</term><term>Placebo tablets</term><term>Present study</term><term>Protocol</term><term>Protocol medication</term><term>Randomisation</term><term>Randomised</term><term>Remission</term><term>Rheum</term><term>Rheumatoid</term><term>Rheumatoid arthritis</term><term>Rheumatoid factor</term><term>Rheumatoid flare</term><term>Rheumatol</term><term>Risk factors</term><term>Second line therapy</term><term>Serum creatinine</term><term>Serum gold concentrations</term><term>Severe flare</term><term>Severe flares</term><term>Significant risk factor</term><term>Soft tissue</term><term>Statistical analysis</term><term>Study centres</term><term>Sulphasalazine</term><term>Swollen joints</term><term>Treatment group</term><term>Treatment groups</term><term>Trial medication</term><term>University hospital leiden</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Abstract: SummaryBackground A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.Methods A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n=142) or received a placebo (n=143). The endpoint was a flare, defined as recurrence of synovitis.Findings At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p=0·002). The risk of a flare was 2·0 times higher for patients receiving placebo than for those continuing the second-line drug (95% Cl 1·27 to 3·17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.Interpretation Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.</div></front></TEI><istex><corpusName>elsevier</corpusName><keywords><teeft><json:string>placebo</json:string><json:string>rheumatoid</json:string><json:string>rheumatoid arthritis</json:string><json:string>placebo group</json:string><json:string>discontinuation</json:string><json:string>flare</json:string><json:string>protocol medication</json:string><json:string>rheumatol</json:string><json:string>methotrexate</json:string><json:string>parenteral</json:string><json:string>arthritis rheum</json:string><json:string>azathioprine</json:string><json:string>parenteral gold</json:string><json:string>rheum</json:string><json:string>arthritis</json:string><json:string>remission</json:string><json:string>chloroquine</json:string><json:string>hydroxychloroquine</json:string><json:string>sulphasalazine</json:string><json:string>randomised</json:string><json:string>articular</json:string><json:string>randomisation</json:string><json:string>nsaid</json:string><json:string>high maintenance dose</json:string><json:string>morning stiffness</json:string><json:string>severe flare</json:string><json:string>disease activity</json:string><json:string>placebo tablets</json:string><json:string>baseline</json:string><json:string>articular index</json:string><json:string>cumulative incidence</json:string><json:string>trial medication</json:string><json:string>flare rate</json:string><json:string>treatment groups</json:string><json:string>rheumatoid flare</json:string><json:string>medication</json:string><json:string>baseline characteristics</json:string><json:string>continuedtreatment group</json:string><json:string>grip strength</json:string><json:string>disease activity indices</json:string><json:string>university hospital leiden</json:string><json:string>more flares</json:string><json:string>protocol</json:string><json:string>independent committee</json:string><json:string>serum creatinine</json:string><json:string>joint tenderness</json:string><json:string>mild flare</json:string><json:string>disease characteristics</json:string><json:string>treatment group</json:string><json:string>statistical analysis</json:string><json:string>foot radiographs</json:string><json:string>rheumatoid factor</json:string><json:string>hospital pharmacy</json:string><json:string>exclusion criteria</json:string><json:string>severe flares</json:string><json:string>logistic regression model</json:string><json:string>active movement</json:string><json:string>study centres</json:string><json:string>soft tissue</json:string><json:string>serum gold concentrations</json:string><json:string>swollen joints</json:string><json:string>flare patients</json:string><json:string>drug group</json:string><json:string>risk factors</json:string><json:string>significant risk factor</json:string><json:string>gastrointestinal complaints</json:string><json:string>methotrexate therapy</json:string><json:string>present study</json:string><json:string>daily dose</json:string><json:string>kennemer gasthuis location</json:string><json:string>continuous therapy</json:string><json:string>longterm treatment</json:string><json:string>clinical trial</json:string><json:string>laboratory tests</json:string><json:string>second line therapy</json:string><json:string>gold therapy</json:string><json:string>clin rheumatol</json:string></teeft></keywords><author><json:item><name>S. ten Wolde MD</name><affiliations><json:string>Department of Rheumatology, University Hospital, Leiden, Netherlands</json:string></affiliations></json:item><json:item><name>F.C. Breedveld MD</name><affiliations><json:string>Department of Rheumatology, University Hospital, Leiden, Netherlands</json:string></affiliations></json:item><json:item><name>B.A.C. Dijkmans MD</name><affiliations><json:string>Correspondence to: Dr B A C Dijkmans, Department of Rheumatology, University Hospital Leiden, Building 1, C4R, PO Box 9600, 2300 RC Leiden, Netherlands</json:string><json:string>Department of Rheumatology, University Hospital, Leiden, Netherlands</json:string></affiliations></json:item><json:item><name>J. Hermans PhD</name><affiliations><json:string>Department of Medical Statistics, University Hospital, Leiden, Netherlands</json:string></affiliations></json:item><json:item><name>J.P. Vandenbroucke MD</name><affiliations><json:string>Department of Clinical Epidemiology, University Hospital, Leiden, Netherlands</json:string></affiliations></json:item><json:item><name>M.A.F.J. van de Laar MD</name><affiliations><json:string>Department of Rheumatology of Medisch Spectrum Twente, Enschede, Netherlands</json:string></affiliations></json:item><json:item><name>H.M. Markusse MD</name><affiliations><json:string>Dr Daniel den Hoed Kliniek Rotterdam, Netherlands</json:string></affiliations></json:item><json:item><name>M. Janssen MD</name><affiliations><json:string>Ziekenhuis Rijnstate, Arnhem, Netherlands</json:string></affiliations></json:item><json:item><name>H.R. van den Brink MD</name><affiliations><json:string>Medisch Centrum Alkmaar Alkmaar, Netherlands</json:string></affiliations></json:item></author><arkIstex>ark:/67375/6H6-0GQ7Q925-Z</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>Full-length article</json:string></originalGenre><abstract>Abstract: SummaryBackground A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.Methods A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n=142) or received a placebo (n=143). The endpoint was a flare, defined as recurrence of synovitis.Findings At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p=0·002). The risk of a flare was 2·0 times higher for patients receiving placebo than for those continuing the second-line drug (95% Cl 1·27 to 3·17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.Interpretation Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.</abstract><qualityIndicators><score>9.425</score><pdfWordCount>4941</pdfWordCount><pdfCharCount>31223</pdfCharCount><pdfVersion>1.4</pdfVersion><pdfPageCount>6</pdfPageCount><pdfPageSize>684 x 977 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractWordCount>207</abstractWordCount><abstractCharCount>1414</abstractCharCount><keywordCount>0</keywordCount></qualityIndicators><title>Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis</title><pmid><json:string>8598699</json:string></pmid><pii><json:string>S0140-6736(96)90535-8</json:string></pii><genre><json:string>research-article</json:string></genre><host><title>The 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xml:id="author-0001"><persName><forename type="first">F.C.</forename><surname>Breedveld</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Rheumatology, University Hospital, Leiden, Netherlands</affiliation></author><author xml:id="author-0002"><persName><forename type="first">B.A.C.</forename><surname>Dijkmans</surname></persName><roleName type="degree">MD</roleName><affiliation>Correspondence to: Dr B A C Dijkmans, Department of Rheumatology, University Hospital Leiden, Building 1, C4R, PO Box 9600, 2300 RC Leiden, Netherlands</affiliation><affiliation>Department of Rheumatology, University Hospital, Leiden, Netherlands</affiliation></author><author xml:id="author-0003"><persName><forename type="first">J.</forename><surname>Hermans</surname></persName><roleName type="degree">PhD</roleName><affiliation>Department of Medical Statistics, University Hospital, Leiden, Netherlands</affiliation></author><author xml:id="author-0004"><persName><forename type="first">J.P.</forename><surname>Vandenbroucke</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Clinical Epidemiology, University Hospital, Leiden, Netherlands</affiliation></author><author xml:id="author-0005"><persName><forename type="first">M.A.F.J.</forename><surname>van de Laar</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Rheumatology of Medisch Spectrum Twente, Enschede, Netherlands</affiliation></author><author xml:id="author-0006"><persName><forename type="first">H.M.</forename><surname>Markusse</surname></persName><roleName type="degree">MD</roleName><affiliation>Dr Daniel den Hoed Kliniek Rotterdam, Netherlands</affiliation></author><author xml:id="author-0007"><persName><forename type="first">M.</forename><surname>Janssen</surname></persName><roleName type="degree">MD</roleName><affiliation>Ziekenhuis Rijnstate, Arnhem, Netherlands</affiliation></author><author xml:id="author-0008"><persName><forename type="first">H.R.</forename><surname>van den Brink</surname></persName><roleName type="degree">MD</roleName><affiliation>Medisch Centrum Alkmaar Alkmaar, Netherlands</affiliation></author><idno type="istex">03F637C3AFE50B8ED82EAE153E91E46760717FC9</idno><idno type="ark">ark:/67375/6H6-0GQ7Q925-Z</idno><idno type="DOI">10.1016/S0140-6736(96)90535-8</idno><idno type="PII">S0140-6736(96)90535-8</idno></analytic><monogr><title level="j">The Lancet</title><title level="j" type="abbrev">LANCET</title><idno type="pISSN">0140-6736</idno><idno type="PII">S0140-6736(00)X9307-5</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1996"></date><biblScope unit="volume">347</biblScope><biblScope unit="issue">8998</biblScope><biblScope unit="page" from="347">347</biblScope><biblScope unit="page" to="352">352</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1996</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Abstract: SummaryBackground A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.Methods A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n=142) or received a placebo (n=143). The endpoint was a flare, defined as recurrence of synovitis.Findings At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p=0·002). The risk of a flare was 2·0 times higher for patients receiving placebo than for those continuing the second-line drug (95% Cl 1·27 to 3·17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.Interpretation Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.</p></abstract></profileDesc><revisionDesc><change when="1996">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/ark:/67375/6H6-0GQ7Q925-Z/fulltext.txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Elsevier, elements deleted: tail"><istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//ES//DTD journal article DTD version 4.5.2//EN//XML" URI="art452.dtd" name="istex:docType"></istex:docType><istex:document><converted-article version="4.5.2" docsubtype="fla"><item-info><jid>LANCET</jid><aid>96905358</aid><ce:pii>S0140-6736(96)90535-8</ce:pii><ce:doi>10.1016/S0140-6736(96)90535-8</ce:doi><ce:copyright type="unknown" year="1996"></ce:copyright></item-info><head><ce:dochead><ce:textfn>Articles</ce:textfn></ce:dochead><ce:title>Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis</ce:title><ce:author-group><ce:author><ce:given-name>S.</ce:given-name><ce:surname>ten Wolde</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="ART7-AFF1"><ce:sup>a</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>F.C.</ce:given-name><ce:surname>Breedveld</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="ART7-AFF1"><ce:sup>a</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>B.A.C.</ce:given-name><ce:surname>Dijkmans</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="ART7-COR1"><ce:sup>*</ce:sup></ce:cross-ref><ce:cross-ref refid="ART7-AFF1"><ce:sup>a</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>J.</ce:given-name><ce:surname>Hermans</ce:surname><ce:degrees>PhD</ce:degrees><ce:cross-ref refid="ART7-AFF2"><ce:sup>b</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>J.P.</ce:given-name><ce:surname>Vandenbroucke</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="ART7-AFF3"><ce:sup>c</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>M.A.F.J.</ce:given-name><ce:surname>van de Laar</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="ART7-AFF4"><ce:sup>d</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>H.M.</ce:given-name><ce:surname>Markusse</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="ART7-AFF5"><ce:sup>e</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>M.</ce:given-name><ce:surname>Janssen</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="ART7-AFF6"><ce:sup>f</ce:sup></ce:cross-ref></ce:author><ce:author><ce:given-name>H.R.</ce:given-name><ce:surname>van den Brink</ce:surname><ce:degrees>MD</ce:degrees><ce:cross-ref refid="ART7-AFF7"><ce:sup>g</ce:sup></ce:cross-ref></ce:author><ce:affiliation id="ART7-AFF1"><ce:label>a</ce:label><ce:textfn>Department of Rheumatology, University Hospital, Leiden, Netherlands</ce:textfn></ce:affiliation><ce:affiliation id="ART7-AFF2"><ce:label>b</ce:label><ce:textfn>Department of Medical Statistics, University Hospital, Leiden, Netherlands</ce:textfn></ce:affiliation><ce:affiliation id="ART7-AFF3"><ce:label>c</ce:label><ce:textfn>Department of Clinical Epidemiology, University Hospital, Leiden, Netherlands</ce:textfn></ce:affiliation><ce:affiliation id="ART7-AFF4"><ce:label>d</ce:label><ce:textfn>Department of Rheumatology of Medisch Spectrum Twente, Enschede, Netherlands</ce:textfn></ce:affiliation><ce:affiliation id="ART7-AFF5"><ce:label>e</ce:label><ce:textfn>Dr Daniel den Hoed Kliniek Rotterdam, Netherlands</ce:textfn></ce:affiliation><ce:affiliation id="ART7-AFF6"><ce:label>f</ce:label><ce:textfn>Ziekenhuis Rijnstate, Arnhem, Netherlands</ce:textfn></ce:affiliation><ce:affiliation id="ART7-AFF7"><ce:label>g</ce:label><ce:textfn>Medisch Centrum Alkmaar Alkmaar, Netherlands</ce:textfn></ce:affiliation><ce:correspondence id="ART7-COR1"><ce:label>*</ce:label><ce:text>Correspondence to: Dr B A C Dijkmans, Department of Rheumatology, University Hospital Leiden, Building 1, C4R, PO Box 9600, 2300 RC Leiden, Netherlands</ce:text></ce:correspondence></ce:author-group><ce:abstract><ce:section-title>Abstract</ce:section-title><ce:abstract-sec><ce:simple-para id="simple-para0005">Summary</ce:simple-para><ce:simple-para id="simple-para0015"><ce:bold>Background</ce:bold> A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.</ce:simple-para><ce:simple-para id="simple-para0025"><ce:bold>Methods</ce:bold> A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n=142) or received a placebo (n=143). The endpoint was a flare, defined as recurrence of synovitis.</ce:simple-para><ce:simple-para id="simple-para0035"><ce:bold>Findings</ce:bold> At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p=0·002). The risk of a flare was 2·0 times higher for patients receiving placebo than for those continuing the second-line drug (95% Cl 1·27 to 3·17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.</ce:simple-para><ce:simple-para id="simple-para0045"><ce:bold>Interpretation</ce:bold> Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.</ce:simple-para></ce:abstract-sec></ce:abstract></head></converted-article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis</title></titleInfo><name type="personal"><namePart type="given">S.</namePart><namePart type="family">ten Wolde</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Rheumatology, University Hospital, Leiden, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">F.C.</namePart><namePart type="family">Breedveld</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Rheumatology, University Hospital, Leiden, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">B.A.C.</namePart><namePart type="family">Dijkmans</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Correspondence to: Dr B A C Dijkmans, Department of Rheumatology, University Hospital Leiden, Building 1, C4R, PO Box 9600, 2300 RC Leiden, Netherlands</affiliation><affiliation>Department of Rheumatology, University Hospital, Leiden, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Hermans</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Department of Medical Statistics, University Hospital, Leiden, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.P.</namePart><namePart type="family">Vandenbroucke</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Clinical Epidemiology, University Hospital, Leiden, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.A.F.J.</namePart><namePart type="family">van de Laar</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Rheumatology of Medisch Spectrum Twente, Enschede, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.M.</namePart><namePart type="family">Markusse</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Dr Daniel den Hoed Kliniek Rotterdam, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Janssen</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Ziekenhuis Rijnstate, Arnhem, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.R.</namePart><namePart type="family">van den Brink</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Medisch Centrum Alkmaar Alkmaar, Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="Full-length 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>ELSEVIER</publisher><dateIssued encoding="w3cdtf">1996</dateIssued><copyrightDate encoding="w3cdtf">1996</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><abstract lang="en">Abstract: SummaryBackground A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.Methods A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n=142) or received a placebo (n=143). The endpoint was a flare, defined as recurrence of synovitis.Findings At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p=0·002). The risk of a flare was 2·0 times higher for patients receiving placebo than for those continuing the second-line drug (95% Cl 1·27 to 3·17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.Interpretation Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.</abstract><note type="content">Section title: Articles</note><relatedItem type="host"><titleInfo><title>The Lancet</title></titleInfo><titleInfo type="abbreviated"><title>LANCET</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><originInfo><publisher>ELSEVIER</publisher><dateIssued encoding="w3cdtf">1996</dateIssued></originInfo><identifier type="ISSN">0140-6736</identifier><identifier type="PII">S0140-6736(00)X9307-5</identifier><part><date>1996</date><detail type="volume"><number>347</number><caption>vol.</caption></detail><detail type="issue"><number>8998</number><caption>no.</caption></detail><extent unit="issue-pages"><start>341</start><end>410</end></extent><extent unit="pages"><start>347</start><end>352</end></extent></part></relatedItem><identifier type="istex">03F637C3AFE50B8ED82EAE153E91E46760717FC9</identifier><identifier type="ark">ark:/67375/6H6-0GQ7Q925-Z</identifier><identifier type="DOI">10.1016/S0140-6736(96)90535-8</identifier><identifier type="PII">S0140-6736(96)90535-8</identifier><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-HKKZVM7B-M">elsevier</recordContentSource></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/6H6-0GQ7Q925-Z/record.json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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