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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 : 001F67

Efficacy 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 :

RBID : pubmed:26056119

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English descriptors

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:


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pubmed:26056119

Le document en format XML

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<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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<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>
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<RefSource>Arthritis Rheum. 2008 Oct;58(10):2968-80</RefSource>
<PMID Version="1">18821691</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites">
<RefSource>Arthritis Care Res (Hoboken). 2014 Nov;66(11):1653-61</RefSource>
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<RefSource>Ann Rheum Dis. 2014 Jan;73(1):69-74</RefSource>
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<RefSource>Arthritis Care Res (Hoboken). 2014 Mar;66(3):344-54</RefSource>
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<RefSource>Lancet. 2008 Mar 22;371(9617):987-97</RefSource>
<PMID Version="1">18358926</PMID>
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<CommentsCorrections RefType="Cites">
<RefSource>Lancet. 2013 May 4;381(9877):1541-50</RefSource>
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<RefSource>Patient Prefer Adherence. 2014 Jan 20;8:93-9</RefSource>
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<CommentsCorrections RefType="Cites">
<RefSource>Ann Rheum Dis. 2008 Nov;67(11):1516-23</RefSource>
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</CommentsCorrections>
<CommentsCorrections RefType="Cites">
<RefSource>Ann Rheum Dis. 2010 Jan;69(1):88-96</RefSource>
<PMID Version="1">19297346</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites">
<RefSource>Patient Prefer Adherence. 2014 Aug 01;8:1051-9</RefSource>
<PMID Version="1">25120354</PMID>
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<CommentsCorrections RefType="Cites">
<RefSource>Arthritis Rheum. 2011 Mar;63(3):609-21</RefSource>
<PMID Version="1">21360490</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites">
<RefSource>Patient Prefer Adherence. 2009 Nov 29;3:335-44</RefSource>
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<RefSource>J Manag Care Pharm. 2011 Nov-Dec;17(9 Suppl B):S14-8</RefSource>
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