Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials
Identifieur interne : 000046 ( France/Analysis ); précédent : 000045; suivant : 000047Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials
Auteurs : Joachim Sieper [Allemagne] ; Benjamin Porter-Brown [Royaume-Uni] ; Liz Thompson [Royaume-Uni] ; Olivier Harari [Royaume-Uni] ; Maxime Dougados [France]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013.
Abstract
BUILDER-1 and BUILDER-2 aimed to assess the efficacy and safety of tocilizumab (TCZ) in patients with ankylosing spondylitis (AS).
BUILDER-1 was a two part, phase II–III parallel-group trial in patients with AS naive to antitumour necrosis factor (aTNF) treatment. Patients in part 1 received TCZ 8 mg/kg or placebo for 12 weeks. In part 2 (beginning after part 1 enrolment ended), newly enrolled patients received TCZ 4 or 8 mg/kg or placebo for 24 weeks. The same treatment arms were used in BUILDER-2, a phase III study in aTNF-inadequate responders. The primary endpoint for both studies was the proportion of patients achieving 20% improvement in the Assessments in Axial SpondyloArthritis international Society (ASAS). Secondary and exploratory endpoints included ASAS40 response rates, Bath Ankylosing Spondylitis Disease Activity Index improvement, changes in joint counts, enthesitis score and C reactive protein (CRP).
102 patients were randomised in BUILDER-1 part 1; 99 (48 TCZ, 51 placebo) completed 12 weeks. Week 12 ASAS20 response rates were 37.3% and 27.5% in the TCZ and placebo arms, respectively (p=0.2823). Secondary and exploratory endpoints did not differ between treatment arms. CRP levels declined with TCZ treatment, suggesting adequate IL-6 receptor blockade. As a result, BUILDER-1 part 2 and BUILDER-2 were terminated. TCZ safety results were consistent with previous observations in rheumatoid arthritis, except for a cluster of anaphylactic and hypersensitivity events at Bulgarian study sites. No apparent explanation for this clustering could be found.
BUILDER-1 failed to demonstrate TCZ efficacy in treating aTNF-naive patients with AS.
NCT01209702 and NCT01209689 (www.clinicaltrials.gov).
Url:
DOI: 10.1136/annrheumdis-2013-203559
PubMed: 23765873
PubMed Central: 3888605
Affiliations:
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PMC:3888605Le document en format XML
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City</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Thompson, Liz" sort="Thompson, Liz" uniqKey="Thompson L" first="Liz" last="Thompson">Liz Thompson</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Roche</institution>,<addr-line>Welwyn Garden City</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Harari, Olivier" sort="Harari, Olivier" uniqKey="Harari O" first="Olivier" last="Harari">Olivier Harari</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Roche</institution>,<addr-line>Welwyn Garden City</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Department of Rheumatology B</addr-line>,<institution>René Descartes University-Paris 5 and Cochin Hospital</institution>,<addr-line>Paris</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23765873</idno><idno type="pmc">3888605</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3888605</idno><idno type="RBID">PMC:3888605</idno><idno type="doi">10.1136/annrheumdis-2013-203559</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">000312</idno><idno type="wicri:Area/Pmc/Curation">000312</idno><idno 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Universitätsmedizin</institution>,<addr-line>Berlin</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Porter Brown, Benjamin" sort="Porter Brown, Benjamin" uniqKey="Porter Brown B" first="Benjamin" last="Porter-Brown">Benjamin Porter-Brown</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Roche</institution>,<addr-line>Welwyn Garden City</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Thompson, Liz" sort="Thompson, Liz" uniqKey="Thompson L" first="Liz" last="Thompson">Liz Thompson</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Roche</institution>,<addr-line>Welwyn Garden City</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Harari, Olivier" sort="Harari, Olivier" uniqKey="Harari O" first="Olivier" last="Harari">Olivier Harari</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Roche</institution>,<addr-line>Welwyn Garden City</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Department of Rheumatology B</addr-line>,<institution>René Descartes University-Paris 5 and Cochin Hospital</institution>,<addr-line>Paris</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Annals of the Rheumatic Diseases</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objectives</title><p>BUILDER-1 and BUILDER-2 aimed to assess the efficacy and safety of tocilizumab (TCZ) in patients with ankylosing spondylitis (AS).</p></sec><sec><title>Methods</title><p>BUILDER-1 was a two part, phase II–III parallel-group trial in patients with AS naive to antitumour necrosis factor (aTNF) treatment. Patients in part 1 received TCZ 8 mg/kg or placebo for 12 weeks. In part 2 (beginning after part 1 enrolment ended), newly enrolled patients received TCZ 4 or 8 mg/kg or placebo for 24 weeks. The same treatment arms were used in BUILDER-2, a phase III study in aTNF-inadequate responders. The primary endpoint for both studies was the proportion of patients achieving 20% improvement in the Assessments in Axial SpondyloArthritis international Society (ASAS). Secondary and exploratory endpoints included ASAS40 response rates, Bath Ankylosing Spondylitis Disease Activity Index improvement, changes in joint counts, enthesitis score and C reactive protein (CRP).</p></sec><sec><title>Results</title><p>102 patients were randomised in BUILDER-1 part 1; 99 (48 TCZ, 51 placebo) completed 12 weeks. Week 12 ASAS20 response rates were 37.3% and 27.5% in the TCZ and placebo arms, respectively (p=0.2823). Secondary and exploratory endpoints did not differ between treatment arms. CRP levels declined with TCZ treatment, suggesting adequate IL-6 receptor blockade. As a result, BUILDER-1 part 2 and BUILDER-2 were terminated. TCZ safety results were consistent with previous observations in rheumatoid arthritis, except for a cluster of anaphylactic and hypersensitivity events at Bulgarian study sites. No apparent explanation for this clustering could be found.</p></sec><sec><title>Conclusions</title><p>BUILDER-1 failed to demonstrate TCZ efficacy in treating aTNF-naive patients with AS.</p></sec><sec><title>Clinical trial registration numbers:</title><p>NCT01209702 and NCT01209689 (www.clinicaltrials.gov).</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Tam, Ls" uniqKey="Tam L">LS Tam</name></author><author><name sortKey="Gu, J" uniqKey="Gu J">J Gu</name></author><author><name sortKey="Yu, D" uniqKey="Yu D">D Yu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rosenbaum, J" uniqKey="Rosenbaum J">J Rosenbaum</name></author><author><name sortKey="Chandran, V" uniqKey="Chandran V">V Chandran</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Akkoc, N" uniqKey="Akkoc N">N Akkoc</name></author><author><name sortKey="Khan, Ma" uniqKey="Khan M">MA 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Choi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sieper, J" uniqKey="Sieper J">J Sieper</name></author><author><name sortKey="Inman, Rd" uniqKey="Inman R">RD Inman</name></author><author><name sortKey="Badalamente, S" uniqKey="Badalamente S">S Badalamente</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Schiff, Mh" uniqKey="Schiff M">MH Schiff</name></author><author><name sortKey="Kremer, Jm" uniqKey="Kremer J">JM Kremer</name></author><author><name sortKey="Jahreis, A" uniqKey="Jahreis A">A Jahreis</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>France</li><li>Royaume-Uni</li></country></list><tree><country name="Allemagne"><noRegion><name sortKey="Sieper, Joachim" sort="Sieper, Joachim" uniqKey="Sieper J" first="Joachim" last="Sieper">Joachim Sieper</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Porter Brown, Benjamin" sort="Porter Brown, Benjamin" uniqKey="Porter Brown B" first="Benjamin" last="Porter-Brown">Benjamin Porter-Brown</name></noRegion><name sortKey="Harari, Olivier" sort="Harari, Olivier" uniqKey="Harari O" first="Olivier" last="Harari">Olivier Harari</name><name sortKey="Thompson, Liz" sort="Thompson, Liz" uniqKey="Thompson L" first="Liz" last="Thompson">Liz Thompson</name></country><country name="France"><noRegion><name sortKey="Dougados, Maxime" sort="Dougados, Maxime" uniqKey="Dougados M" first="Maxime" last="Dougados">Maxime Dougados</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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HfdIndexSelect -h $EXPLOR_AREA/Data/France/Analysis/RBID.i -Sk "pubmed:23765873" \
| HfdSelect -Kh $EXPLOR_AREA/Data/France/Analysis/biblio.hfd \
| NlmPubMed2Wicri -a OpenAccessBelV2
| This area was generated with Dilib version V0.6.25. |  |