Serveur d'exploration Tocilizumab

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Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial.

Identifieur interne : 001543 ( Ncbi/Merge ); précédent : 001542; suivant : 001544

Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial.

Auteurs : Gerd R. Burmester [Allemagne] ; William F. Rigby [États-Unis] ; Ronald F. Van Vollenhoven [Suède] ; Jonathan Kay [États-Unis] ; Andrea Rubbert-Roth [Allemagne] ; Ricardo Blanco [Espagne] ; Alysha Kadva [États-Unis] ; Sophie Dimonaco [Royaume-Uni]

Source :

RBID : pubmed:28389552

Descripteurs français

English descriptors

Abstract

Investigate whether the efficacy and safety of intravenous tocilizumab (TCZ) demonstrated at week 52 in patients with early rheumatoid arthritis (RA) are maintained to week 104.

DOI: 10.1136/annrheumdis-2016-210561
PubMed: 28389552

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pubmed:28389552

Le document en format XML

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<term>Adult</term>
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<term>Antirheumatic Agents (therapeutic use)</term>
<term>Arthritis, Rheumatoid (diagnostic imaging)</term>
<term>Arthritis, Rheumatoid (drug therapy)</term>
<term>Disease Progression</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Joints (diagnostic imaging)</term>
<term>Male</term>
<term>Medication Therapy Management</term>
<term>Methotrexate (therapeutic use)</term>
<term>Middle Aged</term>
<term>Radiography</term>
<term>Remission Induction</term>
<term>Treatment Outcome</term>
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<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Anticorps monoclonaux humanisés (usage thérapeutique)</term>
<term>Antirhumatismaux (usage thérapeutique)</term>
<term>Articulations (imagerie diagnostique)</term>
<term>Femelle</term>
<term>Gestion de la pharmacothérapie</term>
<term>Humains</term>
<term>Induction de rémission</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Méthotrexate (usage thérapeutique)</term>
<term>Polyarthrite rhumatoïde (imagerie diagnostique)</term>
<term>Polyarthrite rhumatoïde (traitement médicamenteux)</term>
<term>Radiographie</term>
<term>Résultat thérapeutique</term>
<term>Évolution de la maladie</term>
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<term>Antibodies, Monoclonal, Humanized</term>
<term>Antirheumatic Agents</term>
<term>Methotrexate</term>
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<keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en">
<term>Arthritis, Rheumatoid</term>
<term>Joints</term>
</keywords>
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<term>Arthritis, Rheumatoid</term>
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<term>Articulations</term>
<term>Polyarthrite rhumatoïde</term>
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<term>Polyarthrite rhumatoïde</term>
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<term>Anticorps monoclonaux humanisés</term>
<term>Antirhumatismaux</term>
<term>Méthotrexate</term>
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<term>Adult</term>
<term>Disease Progression</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Medication Therapy Management</term>
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<term>Remission Induction</term>
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<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Gestion de la pharmacothérapie</term>
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<term>Induction de rémission</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
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<front>
<div type="abstract" xml:lang="en">Investigate whether the efficacy and safety of intravenous tocilizumab (TCZ) demonstrated at week 52 in patients with early rheumatoid arthritis (RA) are maintained to week 104.</div>
</front>
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<PMID Version="1">28389552</PMID>
<DateCompleted>
<Year>2017</Year>
<Month>08</Month>
<Day>21</Day>
</DateCompleted>
<DateRevised>
<Year>2018</Year>
<Month>11</Month>
<Day>13</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1468-2060</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>76</Volume>
<Issue>7</Issue>
<PubDate>
<Year>2017</Year>
<Month>Jul</Month>
</PubDate>
</JournalIssue>
<Title>Annals of the rheumatic diseases</Title>
<ISOAbbreviation>Ann. Rheum. Dis.</ISOAbbreviation>
</Journal>
<ArticleTitle>Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial.</ArticleTitle>
<Pagination>
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<Abstract>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Investigate whether the efficacy and safety of intravenous tocilizumab (TCZ) demonstrated at week 52 in patients with early rheumatoid arthritis (RA) are maintained to week 104.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Methotrexate (MTX)-naive patients with early progressive RA were randomly assigned to double-blind 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo or placebo+MTX for 104 weeks. Patients not receiving 8 mg/kg TCZ and not achieving Disease Activity Score-28 joints (DAS28-erythrocyte sedimentation rate (ESR)) ≤3.2 at week 52 switched to escape therapy (8 mg/kg TCZ+MTX). Analyses were exploratory.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Intent-to-treat and safety populations included 1157 and 1153 patients, respectively. DAS28-ESR remission (<2.6) rates were maintained from weeks 52 to 104 (eg, 8 mg/kg TCZ+MTX, 49.3% to 47.6%). Placebo+MTX and 4 mg/kg TCZ+MTX escape patients' week 104 response rates were 51.4% and 30.5%, respectively. Inhibition of radiographic progression was maintained with 8 mg/kg TCZ (eg, 8 mg/kg TCZ+MTX mean (SD) change from baseline in modified total Sharp score: 0.13 (1.28), week 52; 0.19 (2.08), week 104). The safety profile of TCZ was consistent with that of previous reports.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Patients with early RA treated with TCZ monotherapy or TCZ+MTX maintained clinical benefits during their second year of treatment with no new safety signals.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION NUMBER" NlmCategory="BACKGROUND">NCT01007435; Results.</AbstractText>
<CopyrightInformation>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.</CopyrightInformation>
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<ForeName>Gerd R</ForeName>
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<Affiliation>Karolinska Institute, Stockholm, Sweden.</Affiliation>
</AffiliationInfo>
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<Affiliation>UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, Massachusetts, USA.</Affiliation>
</AffiliationInfo>
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<LastName>Rubbert-Roth</LastName>
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<Affiliation>University of Cologne, Cologne, Germany.</Affiliation>
</AffiliationInfo>
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<LastName>Blanco</LastName>
<ForeName>Ricardo</ForeName>
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<Affiliation>Hospital Universitario Marqués de Valdecilla, Santander, Spain.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
</Author>
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<LastName>Dimonaco</LastName>
<ForeName>Sophie</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Roche Products Ltd., Welwyn Garden City, UK.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
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<DataBank>
<DataBankName>ClinicalTrials.gov</DataBankName>
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<AccessionNumber>NCT01007435</AccessionNumber>
</AccessionNumberList>
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<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
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<ArticleDate DateType="Electronic">
<Year>2017</Year>
<Month>04</Month>
<Day>07</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>England</Country>
<MedlineTA>Ann Rheum Dis</MedlineTA>
<NlmUniqueID>0372355</NlmUniqueID>
<ISSNLinking>0003-4967</ISSNLinking>
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<ChemicalList>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D018501">Antirheumatic Agents</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>I031V2H011</RegistryNumber>
<NameOfSubstance UI="C502936">tocilizumab</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>YL5FZ2Y5U1</RegistryNumber>
<NameOfSubstance UI="D008727">Methotrexate</NameOfSubstance>
</Chemical>
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<CitationSubset>IM</CitationSubset>
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<QualifierName UI="Q000000981" MajorTopicYN="N">diagnostic imaging</QualifierName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
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<CoiStatement>Competing interests: GRB has received honoraria from Roche for lectures and consulting. WFR reports grants and personal fees from Roche outside the submitted work. RFvV reports grants from Roche during the conduct of the study; grants from AbbVie, Amgen, BMS, GSK, Pfizer, Roche, UCB; and personal fees from AbbVie, Biotest, BMS, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, and Vertex outside the submitted work. JK reports grants and personal fees from AbbVie, Eli Lilly and Company, Genentech, Pfizer, Roche Laboratories and UCB; and personal fees from Amgen, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Crescendo Bioscience, Epirus Biopharmaceuticals, GlaxoSmithKline, Hospira, Janssen Biotech, Merck Sharp & Dohme, Novartis Pharmaceuticals, Regeneron Pharmaceuticals, Samsung Bioepis and Sandoz outside the submitted work. AR-R reports personal fees from Roche and Chugai during the conduct of the study and personal fees from Pfizer, Lilly, BMS, AbbVie, MSD, UCB, Janssen, Sanofi and Boehringer outside the submitted work. RB reports grants from Roche, Merck Sharp & Dohme and AbbVie outside the submitted work. AK is an employee of Genentech. SD is an employee of Roche Products.</CoiStatement>
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