Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA).
Identifieur interne : 001F66 ( PubMed/Checkpoint ); précédent : 001F65; suivant : 001F67Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA).
Auteurs : Gerd R. Burmester [Allemagne] ; Andrea Rubbert-Roth [Allemagne] ; Alain Cantagrel [France] ; Stephen Hall [Australie] ; Piotr Leszczynski [Pologne] ; Daniel Feldman [Brésil] ; Madura J. Rangaraj [États-Unis] ; Georgia Roane [États-Unis] ; Charles Ludivico [États-Unis] ; Min Bao [États-Unis] ; Lucy Rowell [Royaume-Uni] ; Claire Davies [Royaume-Uni] ; Eduardo F. Mysler [Argentine]Source :
- Annals of the rheumatic diseases [ 1468-2060 ] ; 2016.
Descripteurs français
- KwdFr :
- Anticorps monoclonaux humanisés (administration et posologie), Anticorps monoclonaux humanisés (effets indésirables), Antirhumatismaux (administration et posologie), Antirhumatismaux (effets indésirables), Association de médicaments, Facteurs temps, Humains, Indice de gravité médicale, Injections sous-cutanées, Injections veineuses, Méthode en double aveugle, Polyarthrite rhumatoïde (traitement médicamenteux), Résultat thérapeutique, Voies d'administration de substances chimiques et des médicaments.
- MESH :
- administration et posologie : Anticorps monoclonaux humanisés, Antirhumatismaux.
- effets indésirables : Anticorps monoclonaux humanisés, Antirhumatismaux.
- traitement médicamenteux : Polyarthrite rhumatoïde.
- Association de médicaments, Facteurs temps, Humains, Indice de gravité médicale, Injections sous-cutanées, Injections veineuses, Méthode en double aveugle, Résultat thérapeutique, Voies d'administration de substances chimiques et des médicaments.
English descriptors
- KwdEn :
- Antibodies, Monoclonal, Humanized (administration & dosage), Antibodies, Monoclonal, Humanized (adverse effects), Antirheumatic Agents (administration & dosage), Antirheumatic Agents (adverse effects), Arthritis, Rheumatoid (drug therapy), Double-Blind Method, Drug Administration Routes, Drug Therapy, Combination, Humans, Injections, Intravenous, Injections, Subcutaneous, Severity of Illness Index, Time Factors, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized, Antirheumatic Agents.
- chemical , adverse effects : Antibodies, Monoclonal, Humanized, Antirheumatic Agents.
- drug therapy : Arthritis, Rheumatoid.
- Double-Blind Method, Drug Administration Routes, Drug Therapy, Combination, Humans, Injections, Intravenous, Injections, Subcutaneous, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs).
DOI: 10.1136/annrheumdis-2015-207281
PubMed: 26056119
Affiliations:
- Allemagne, Argentine, Australie, Brésil, France, Pologne, Royaume-Uni, États-Unis
- Berlin, Californie, Caroline du Sud, District de Cologne, Louisiane, Midi-Pyrénées, Occitanie (région administrative), Pennsylvanie, Rhénanie-du-Nord-Westphalie, État de São Paulo
- Berlin, Cologne, São Paulo, Toulouse
- Université de Cologne
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:26056119Le document en format XML
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<term>Antirhumatismaux (effets indésirables)</term>
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<front><div type="abstract" xml:lang="en">To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs).</div>
</front>
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<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26056119</PMID>
<DateCreated><Year>2015</Year>
<Month>12</Month>
<Day>15</Day>
</DateCreated>
<DateCompleted><Year>2016</Year>
<Month>04</Month>
<Day>04</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>02</Month>
<Day>20</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1468-2060</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>75</Volume>
<Issue>1</Issue>
<PubDate><Year>2016</Year>
<Month>Jan</Month>
</PubDate>
</JournalIssue>
<Title>Annals of the rheumatic diseases</Title>
<ISOAbbreviation>Ann. Rheum. Dis.</ISOAbbreviation>
</Journal>
<ArticleTitle>Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA).</ArticleTitle>
<Pagination><MedlinePgn>68-74</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1136/annrheumdis-2015-207281</ELocationID>
<Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs).</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients (n=1262) were randomised 1:1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11:1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SC-IV, n=48), and patients receiving TCZ-IV were re-randomised 2:1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SC; n=186). Maintenance of clinical responses and safety through week 97 were assessed.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The proportions of patients who achieved American College of Rheumatology (ACR)20/50/70 responses, Disease Activity Score in 28 joints remission and improvement from baseline in Health Assessment Questionnaire Disability Index ≥0.3 were sustained through week 97 and comparable across arms. TCZ-SC had a comparable safety profile to TCZ-IV through week 97, except that injection site reactions (ISRs) were more common with TCZ-SC. Safety profiles in patients who switched were similar to those in patients who received continuous TCZ-SC or TCZ-IV treatment. The proportion of patients who developed anti-TCZ antibodies remained low across treatment arms. No association between anti-TCZ antibody development and clinical response or adverse events was observed.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The long-term efficacy and safety of TCZ-SC was maintained and comparable to that of TCZ-IV, except for ISRs. Profiles in patients who switched formulations were comparable to those in patients who received TCZ-IV or TCZ-SC. TCZ-SC provides additional treatment options for patients with RA.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION NUMBER" NlmCategory="BACKGROUND">NCT01194414.</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>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Burmester</LastName>
<ForeName>Gerd R</ForeName>
<Initials>GR</Initials>
<AffiliationInfo><Affiliation>Free University and Humboldt University of Berlin, Berlin, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rubbert-Roth</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Klinikum der Universität zu Köln, Köln, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cantagrel</LastName>
<ForeName>Alain</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Centre Hospitalier Universitaire de Toulouse, Toulouse, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hall</LastName>
<ForeName>Stephen</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Cabrini Medical Centre, Malvern, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Leszczynski</LastName>
<ForeName>Piotr</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Poznan Medical University, Poznan, Poland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Feldman</LastName>
<ForeName>Daniel</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Universidade Federal de São Paulo, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rangaraj</LastName>
<ForeName>Madura J</ForeName>
<Initials>MJ</Initials>
<AffiliationInfo><Affiliation>Arthritis & Diabetes Clinic, Inc, Monroe, Louisiana, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Roane</LastName>
<ForeName>Georgia</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Rheumatology Associates of South Carolina, Charleston, South Carolina, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ludivico</LastName>
<ForeName>Charles</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>East Penn Rheumatology Associates, Bethlehem, Pennsylvania, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bao</LastName>
<ForeName>Min</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Genentech Inc, South San Francisco, California, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rowell</LastName>
<ForeName>Lucy</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Roche Products Limited, Welwyn Garden City, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Davies</LastName>
<ForeName>Claire</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Roche Products Limited, Welwyn Garden City, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mysler</LastName>
<ForeName>Eduardo F</ForeName>
<Initials>EF</Initials>
<AffiliationInfo><Affiliation>Organizacion Medica de Investigación, Buenos Aires, Argentina.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT01194414</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D003160">Comparative Study</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2015</Year>
<Month>06</Month>
<Day>08</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Ann Rheum Dis</MedlineTA>
<NlmUniqueID>0372355</NlmUniqueID>
<ISSNLinking>0003-4967</ISSNLinking>
</MedlineJournalInfo>
<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>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Arthritis Rheum. 2008 Oct;58(10):2968-80</RefSource>
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</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Ann Rheum Dis. 2010 Jan;69(1):88-96</RefSource>
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<PMID Version="1">22073935</PMID>
</CommentsCorrections>
</CommentsCorrectionsList>
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<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
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<MeshHeading><DescriptorName UI="D018501" MajorTopicYN="N">Antirheumatic Agents</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D001172" MajorTopicYN="N">Arthritis, Rheumatoid</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004333" MajorTopicYN="N">Drug Administration Routes</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007275" MajorTopicYN="N">Injections, Intravenous</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007279" MajorTopicYN="N">Injections, Subcutaneous</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<OtherID Source="NLM">PMC4717437</OtherID>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">DMARDs (biologic)</Keyword>
<Keyword MajorTopicYN="N">Rheumatoid Arthritis</Keyword>
<Keyword MajorTopicYN="N">Treatment</Keyword>
</KeywordList>
</MedlineCitation>
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<Month>01</Month>
<Day>09</Day>
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<PubMedPubDate PubStatus="accepted"><Year>2015</Year>
<Month>05</Month>
<Day>10</Day>
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<affiliations><list><country><li>Allemagne</li>
<li>Argentine</li>
<li>Australie</li>
<li>Brésil</li>
<li>France</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
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<li>Toulouse</li>
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<orgName><li>Université de Cologne</li>
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<tree><country name="Allemagne"><region name="Berlin"><name sortKey="Burmester, Gerd R" sort="Burmester, Gerd R" uniqKey="Burmester G" first="Gerd R" last="Burmester">Gerd R. Burmester</name>
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<name sortKey="Rubbert Roth, Andrea" sort="Rubbert Roth, Andrea" uniqKey="Rubbert Roth A" first="Andrea" last="Rubbert-Roth">Andrea Rubbert-Roth</name>
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<country name="Brésil"><region name="État de São Paulo"><name sortKey="Feldman, Daniel" sort="Feldman, Daniel" uniqKey="Feldman D" first="Daniel" last="Feldman">Daniel Feldman</name>
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