Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study
Identifieur interne : 000045 ( France/Analysis ); précédent : 000044; suivant : 000046Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study
Auteurs : R. Landewé [Pays-Bas] ; J. Braun [Allemagne] ; A. Deodhar [États-Unis] ; M. Dougados [France] ; W P Maksymowych [Canada] ; P J Mease [États-Unis] ; J D Reveille [États-Unis] ; M. Rudwaleit [Allemagne] ; D. Van Der Heijde [Pays-Bas] ; C. Stach [Allemagne] ; B. Hoepken [Allemagne] ; A. Fichtner [Allemagne] ; G. Coteur [Belgique] ; M. De Longueville [Belgique] ; J. Sieper [Allemagne]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013.
Abstract
To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-axSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA).
Patients with active axSpA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). In total 325 patients were randomised. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society 20) response at week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear.
Baseline disease activity was similar between AS and nr-axSpA. At week 12, ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). At week 24, combined CZP arms showed significant (p<0.001) differences in change from baseline versus placebo in BASFI (−2.28 vs −0.40), BASDAI (−3.05 vs −1.05), and BASMI (−0.52 vs −0.07). Improvements were observed as early as week 1. Similar improvements were reported with CZP versus placebo in both AS and nr-axSpA subpopulations. Adverse events were reported in 70.4% vs 62.6%, and serious adverse events in 4.7% vs 4.7% of All CZP versus placebo groups. No deaths or malignancies were reported.
CZP rapidly reduced the signs and symptoms of axSpA, with no new safety signals observed compared to the safety profile of CZP in RA. Similar improvements were observed across CZP dosing regimens, and in AS and nr-axSpA patients.
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DOI: 10.1136/annrheumdis-2013-204231
PubMed: 24013647
PubMed Central: 3888598
Affiliations:
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Stach</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>UCB Pharma</institution>,<addr-line>Monheim</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="Hoepken, B" sort="Hoepken, B" uniqKey="Hoepken B" first="B" last="Hoepken">B. Hoepken</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>UCB Pharma</institution>,<addr-line>Monheim</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="Fichtner, A" sort="Fichtner, A" uniqKey="Fichtner A" first="A" last="Fichtner">A. Fichtner</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>UCB Pharma</institution>,<addr-line>Monheim</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="Coteur, G" sort="Coteur, G" uniqKey="Coteur G" first="G" last="Coteur">G. Coteur</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>UCB Pharma</institution>,<addr-line>Brussels</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="De Longueville, M" sort="De Longueville, M" uniqKey="De Longueville M" first="M" last="De Longueville">M. De Longueville</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>UCB Pharma</institution>,<addr-line>Brussels</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sieper, J" sort="Sieper, J" uniqKey="Sieper J" first="J" last="Sieper">J. Sieper</name><affiliation wicri:level="1"><nlm:aff id="af12"><addr-line>Rheumatology Department</addr-line>,<institution>University Hospital Charité</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></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24013647</idno><idno type="pmc">3888598</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3888598</idno><idno type="RBID">PMC:3888598</idno><idno type="doi">10.1136/annrheumdis-2013-204231</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">000315</idno><idno type="wicri:Area/Pmc/Curation">000315</idno><idno type="wicri:Area/Pmc/Checkpoint">000276</idno><idno type="wicri:Area/Ncbi/Merge">000201</idno><idno type="wicri:Area/Ncbi/Curation">000201</idno><idno type="wicri:Area/Ncbi/Checkpoint">000201</idno><idno type="wicri:doubleKey">0003-4967:2013:Landewe R:efficacy:of:certolizumab</idno><idno type="wicri:Area/Main/Merge">000323</idno><idno type="wicri:Area/Main/Curation">000323</idno><idno type="wicri:Area/Main/Exploration">000323</idno><idno type="wicri:Area/France/Extraction">000045</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study</title><author><name sortKey="Landewe, R" sort="Landewe, R" uniqKey="Landewe R" first="R" last="Landewé">R. Landewé</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>Academic Medical Center Amsterdam & Atrium Medical Center Heerlen</institution>,<addr-line>Amsterdam</addr-line>,<country>The Netherlands</country></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Braun, J" sort="Braun, J" uniqKey="Braun J" first="J" last="Braun">J. Braun</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Rheumazentrum Ruhrgebiet</institution>,<addr-line>Herne</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="Deodhar, A" sort="Deodhar, A" uniqKey="Deodhar A" first="A" last="Deodhar">A. Deodhar</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Oregon Health & Science University</institution>,<addr-line>Portland, Oregon</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dougados, M" sort="Dougados, M" uniqKey="Dougados M" first="M" last="Dougados">M. Dougados</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Department of Rheumatology</addr-line>,<institution>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><author><name sortKey="Maksymowych, W P" sort="Maksymowych, W P" uniqKey="Maksymowych W" first="W P" last="Maksymowych">W P Maksymowych</name><affiliation wicri:level="1"><nlm:aff id="af5"><addr-line>Department of Medicine</addr-line>,<institution>University of Alberta</institution>,<addr-line>Edmonton</addr-line>,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mease, P J" sort="Mease, P J" uniqKey="Mease P" first="P J" last="Mease">P J Mease</name><affiliation wicri:level="1"><nlm:aff id="af6"><institution>Swedish Medical Center, University of Washington</institution>,<addr-line>Seattle, Washington</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Reveille, J D" sort="Reveille, J D" uniqKey="Reveille J" first="J D" last="Reveille">J D Reveille</name><affiliation wicri:level="1"><nlm:aff id="af7"><addr-line>Division of Rheumatology</addr-line>,<institution>University of Texas Health Science Center at Houston</institution>,<addr-line>Houston, Texas</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rudwaleit, M" sort="Rudwaleit, M" uniqKey="Rudwaleit M" first="M" last="Rudwaleit">M. Rudwaleit</name><affiliation wicri:level="1"><nlm:aff id="af8"><institution>Endokrinologikum Berlin</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="Van Der Heijde, D" sort="Van Der Heijde, D" uniqKey="Van Der Heijde D" first="D" last="Van Der Heijde">D. Van Der Heijde</name><affiliation wicri:level="1"><nlm:aff id="af9"><addr-line>Department of Rheumatology</addr-line>,<institution>Leiden University Medical Centre</institution>,<addr-line>Leiden</addr-line>,<country>The Netherlands</country></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Stach, C" sort="Stach, C" uniqKey="Stach C" first="C" last="Stach">C. Stach</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>UCB Pharma</institution>,<addr-line>Monheim</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="Hoepken, B" sort="Hoepken, B" uniqKey="Hoepken B" first="B" last="Hoepken">B. Hoepken</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>UCB Pharma</institution>,<addr-line>Monheim</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="Fichtner, A" sort="Fichtner, A" uniqKey="Fichtner A" first="A" last="Fichtner">A. Fichtner</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>UCB Pharma</institution>,<addr-line>Monheim</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="Coteur, G" sort="Coteur, G" uniqKey="Coteur G" first="G" last="Coteur">G. Coteur</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>UCB Pharma</institution>,<addr-line>Brussels</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="De Longueville, M" sort="De Longueville, M" uniqKey="De Longueville M" first="M" last="De Longueville">M. De Longueville</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>UCB Pharma</institution>,<addr-line>Brussels</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sieper, J" sort="Sieper, J" uniqKey="Sieper J" first="J" last="Sieper">J. Sieper</name><affiliation wicri:level="1"><nlm:aff id="af12"><addr-line>Rheumatology Department</addr-line>,<institution>University Hospital Charité</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></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>To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-axSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA).</p></sec><sec><title>Methods</title><p>Patients with active axSpA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). In total 325 patients were randomised. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society 20) response at week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear.</p></sec><sec><title>Results</title><p>Baseline disease activity was similar between AS and nr-axSpA. At week 12, ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). At week 24, combined CZP arms showed significant (p<0.001) differences in change from baseline versus placebo in BASFI (−2.28 vs −0.40), BASDAI (−3.05 vs −1.05), and BASMI (−0.52 vs −0.07). Improvements were observed as early as week 1. Similar improvements were reported with CZP versus placebo in both AS and nr-axSpA subpopulations. Adverse events were reported in 70.4% vs 62.6%, and serious adverse events in 4.7% vs 4.7% of All CZP versus placebo groups. No deaths or malignancies were reported.</p></sec><sec><title>Conclusions</title><p>CZP rapidly reduced the signs and symptoms of axSpA, with no new safety signals observed compared to the safety profile of CZP in RA. Similar improvements were observed across CZP dosing regimens, and in AS and nr-axSpA patients.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Sieper, J" uniqKey="Sieper J">J Sieper</name></author><author><name sortKey="Rudwaleit, M" uniqKey="Rudwaleit M">M Rudwaleit</name></author><author><name sortKey="Baraliakos, X" uniqKey="Baraliakos X">X Baraliakos</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Van Der Linden, S" uniqKey="Van Der Linden S">S van der Linden</name></author><author><name sortKey="Valkenburg, Ha" uniqKey="Valkenburg H">HA Valkenburg</name></author><author><name sortKey="Cats, A" uniqKey="Cats A">A Cats</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rudwaleit, M" uniqKey="Rudwaleit M">M Rudwaleit</name></author><author><name sortKey="Landewe, R" uniqKey="Landewe R">R Landewé</name></author><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rudwaleit, M" uniqKey="Rudwaleit M">M Rudwaleit</name></author><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Landewe, R" uniqKey="Landewe R">R Landewé</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Van Den Berg, R" uniqKey="Van Den Berg R">R van den Berg</name></author><author><name sortKey="De Hooge, M" uniqKey="De Hooge M">M de Hooge</name></author><author><name sortKey="Rudwaleit, M" uniqKey="Rudwaleit M">M Rudwaleit</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rudwaleit, M" uniqKey="Rudwaleit M">M Rudwaleit</name></author><author><name sortKey="Van Der Heijde, D" uniqKey="Van Der Heijde D">D van der Heijde</name></author><author><name sortKey="Khan, Ma" uniqKey="Khan M">MA 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Mease</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>Canada</li><li>France</li><li>Pays-Bas</li><li>États-Unis</li></country></list><tree><country name="Pays-Bas"><noRegion><name sortKey="Landewe, R" sort="Landewe, R" uniqKey="Landewe R" first="R" last="Landewé">R. Landewé</name></noRegion><name sortKey="Van Der Heijde, D" sort="Van Der Heijde, D" uniqKey="Van Der Heijde D" first="D" last="Van Der Heijde">D. Van Der Heijde</name></country><country name="Allemagne"><noRegion><name sortKey="Braun, J" sort="Braun, J" uniqKey="Braun J" first="J" last="Braun">J. Braun</name></noRegion><name sortKey="Fichtner, A" sort="Fichtner, A" uniqKey="Fichtner A" first="A" last="Fichtner">A. Fichtner</name><name sortKey="Hoepken, B" sort="Hoepken, B" uniqKey="Hoepken B" first="B" last="Hoepken">B. Hoepken</name><name sortKey="Rudwaleit, M" sort="Rudwaleit, M" uniqKey="Rudwaleit M" first="M" last="Rudwaleit">M. Rudwaleit</name><name sortKey="Sieper, J" sort="Sieper, J" uniqKey="Sieper J" first="J" last="Sieper">J. Sieper</name><name sortKey="Stach, C" sort="Stach, C" uniqKey="Stach C" first="C" last="Stach">C. Stach</name></country><country name="États-Unis"><noRegion><name sortKey="Deodhar, A" sort="Deodhar, A" uniqKey="Deodhar A" first="A" last="Deodhar">A. Deodhar</name></noRegion><name sortKey="Mease, P J" sort="Mease, P J" uniqKey="Mease P" first="P J" last="Mease">P J Mease</name><name sortKey="Reveille, J D" sort="Reveille, J D" uniqKey="Reveille J" first="J D" last="Reveille">J D Reveille</name></country><country name="France"><noRegion><name sortKey="Dougados, M" sort="Dougados, M" uniqKey="Dougados M" first="M" last="Dougados">M. Dougados</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Maksymowych, W P" sort="Maksymowych, W P" uniqKey="Maksymowych W" first="W P" last="Maksymowych">W P Maksymowych</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Coteur, G" sort="Coteur, G" uniqKey="Coteur G" first="G" last="Coteur">G. Coteur</name></noRegion><name sortKey="De Longueville, M" sort="De Longueville, M" uniqKey="De Longueville M" first="M" last="De Longueville">M. De Longueville</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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