Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA)
Identifieur interne : 000324 ( Main/Exploration ); précédent : 000323; suivant : 000325Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA)
Auteurs : P J Mease [États-Unis] ; R. Fleischmann [États-Unis] ; A A Deodhar [États-Unis] ; J. Wollenhaupt [Allemagne] ; M. Khraishi [Canada] ; D. Kielar [Belgique] ; F. Woltering [Allemagne] ; C. Stach [Allemagne] ; B. Hoepken [Allemagne] ; T. Arledge [États-Unis] ; D. Van Der Heijde [Pays-Bas]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-PsA (NCT01087788), an ongoing Phase 3 trial in patients with psoriatic arthritis (PsA).
Patients were randomised 1:1:1 to placebo, 200 mg CZP every 2 weeks (Q2W) or 400 mg CZP every 4 weeks (Q4W). Patients could have had exposure to one previous tumour necrosis factor (TNF) inhibitor therapy. Primary endpoints were American College of Rheumatology 20% (ACR20) response at week 12 and modified Total Sharp Score change from baseline at week 24. Secondary endpoints included; Psoriatic Arthritis Response Criteria (PsARC) score, Health Assessment Questionnaire Disability Index (HAQ-DI), Psoriasis Area and Severity Index, Leeds Enthesitis Index, Leeds Dactylitis Index, and Modified Nail Psoriasis Severity Index.
Of 409 patients randomised, 368 completed 24 weeks of treatment. ACR20 response was significantly greater in CZP 200 mg Q2W and 400 mg Q4W-treated patients than placebo (58.0% and 51.9% vs 24.3% (p<0.001)) at week 12, with improvements observed by week 1. There was a statistically significant improvement in physical function from baseline, measured by HAQ-DI in CZP patients compared with placebo (−0.50 vs −0.19, p<0.001) and more patients treated with CZP 200 mg Q2W and CZP 400 mg achieved an improvement in PsARC at week 24 than placebo (78.3% and 77.0% vs 33.1% (p<0.001)). Sustained improvements were observed in psoriatic skin involvement, enthesitis, dactylitis and nail disease. Higher ACR20 response with CZP was independent of prior TNF inhibitor exposure. No new safety signals were observed.
Rapid improvements in the signs and symptoms of PsA, including joints, skin, enthesitis, dactylitis and nail disease were observed across both CZP dosing regimens.
Url:
DOI: 10.1136/annrheumdis-2013-203696
PubMed: 23942868
PubMed Central: 3888622
Affiliations:
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Fleischmann</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>University of Texas SW Medical Center</institution>,<addr-line>Dallas, 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="Deodhar, A A" sort="Deodhar, A A" uniqKey="Deodhar A" first="A A" last="Deodhar">A A Deodhar</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Div Arthritis/Rheumatic Diseases (OPO9)</addr-line>,<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="Wollenhaupt, J" sort="Wollenhaupt, J" uniqKey="Wollenhaupt J" first="J" last="Wollenhaupt">J. Wollenhaupt</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Klinik für Rheumatologie und klinische Immunologie</addr-line>,<institution>Schoen Klinik</institution>,<addr-line>Hamburg</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="Khraishi, M" sort="Khraishi, M" uniqKey="Khraishi M" first="M" last="Khraishi">M. Khraishi</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>Memorial University of Newfoundland, Nexus Clinical Research</institution>,<addr-line>St. John's, Newfoundland and Labrador</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="Kielar, D" sort="Kielar, D" uniqKey="Kielar D" first="D" last="Kielar">D. Kielar</name><affiliation wicri:level="1"><nlm:aff id="af6"><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="Woltering, F" sort="Woltering, F" uniqKey="Woltering F" first="F" last="Woltering">F. Woltering</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>UCB Pharma</institution>,<addr-line>Monheim am Rhein</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="Stach, C" sort="Stach, C" uniqKey="Stach C" first="C" last="Stach">C. Stach</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>UCB Pharma</institution>,<addr-line>Monheim am Rhein</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="af7"><institution>UCB Pharma</institution>,<addr-line>Monheim am Rhein</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="Arledge, T" sort="Arledge, T" uniqKey="Arledge T" first="T" last="Arledge">T. Arledge</name><affiliation wicri:level="1"><nlm:aff id="af8"><institution>UCB Pharma</institution>,<addr-line>Raleigh, North Carolina</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="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></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23942868</idno><idno type="pmc">3888622</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3888622</idno><idno type="RBID">PMC:3888622</idno><idno type="doi">10.1136/annrheumdis-2013-203696</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">000314</idno><idno type="wicri:Area/Pmc/Curation">000314</idno><idno type="wicri:Area/Pmc/Checkpoint">000277</idno><idno type="wicri:Area/Ncbi/Merge">000193</idno><idno type="wicri:Area/Ncbi/Curation">000193</idno><idno type="wicri:Area/Ncbi/Checkpoint">000193</idno><idno type="wicri:doubleKey">0003-4967:2013:Mease P:effect:of:certolizumab</idno><idno type="wicri:Area/Main/Merge">000324</idno><idno type="wicri:Area/Main/Curation">000324</idno><idno type="wicri:Area/Main/Exploration">000324</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA)</title><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="af1"><institution>Swedish Medical Center and 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="Fleischmann, R" sort="Fleischmann, R" uniqKey="Fleischmann R" first="R" last="Fleischmann">R. Fleischmann</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>University of Texas SW Medical Center</institution>,<addr-line>Dallas, 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="Deodhar, A A" sort="Deodhar, A A" uniqKey="Deodhar A" first="A A" last="Deodhar">A A Deodhar</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Div Arthritis/Rheumatic Diseases (OPO9)</addr-line>,<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="Wollenhaupt, J" sort="Wollenhaupt, J" uniqKey="Wollenhaupt J" first="J" last="Wollenhaupt">J. Wollenhaupt</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Klinik für Rheumatologie und klinische Immunologie</addr-line>,<institution>Schoen Klinik</institution>,<addr-line>Hamburg</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="Khraishi, M" sort="Khraishi, M" uniqKey="Khraishi M" first="M" last="Khraishi">M. Khraishi</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>Memorial University of Newfoundland, Nexus Clinical Research</institution>,<addr-line>St. John's, Newfoundland and Labrador</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="Kielar, D" sort="Kielar, D" uniqKey="Kielar D" first="D" last="Kielar">D. Kielar</name><affiliation wicri:level="1"><nlm:aff id="af6"><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="Woltering, F" sort="Woltering, F" uniqKey="Woltering F" first="F" last="Woltering">F. Woltering</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>UCB Pharma</institution>,<addr-line>Monheim am Rhein</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="Stach, C" sort="Stach, C" uniqKey="Stach C" first="C" last="Stach">C. Stach</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>UCB Pharma</institution>,<addr-line>Monheim am Rhein</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="af7"><institution>UCB Pharma</institution>,<addr-line>Monheim am Rhein</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="Arledge, T" sort="Arledge, T" uniqKey="Arledge T" first="T" last="Arledge">T. Arledge</name><affiliation wicri:level="1"><nlm:aff id="af8"><institution>UCB Pharma</institution>,<addr-line>Raleigh, North Carolina</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="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></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-PsA (NCT01087788), an ongoing Phase 3 trial in patients with psoriatic arthritis (PsA).</p></sec><sec><title>Methods</title><p>Patients were randomised 1:1:1 to placebo, 200 mg CZP every 2 weeks (Q2W) or 400 mg CZP every 4 weeks (Q4W). Patients could have had exposure to one previous tumour necrosis factor (TNF) inhibitor therapy. Primary endpoints were American College of Rheumatology 20% (ACR20) response at week 12 and modified Total Sharp Score change from baseline at week 24. Secondary endpoints included; Psoriatic Arthritis Response Criteria (PsARC) score, Health Assessment Questionnaire Disability Index (HAQ-DI), Psoriasis Area and Severity Index, Leeds Enthesitis Index, Leeds Dactylitis Index, and Modified Nail Psoriasis Severity Index.</p></sec><sec><title>Results</title><p>Of 409 patients randomised, 368 completed 24 weeks of treatment. ACR20 response was significantly greater in CZP 200 mg Q2W and 400 mg Q4W-treated patients than placebo (58.0% and 51.9% vs 24.3% (p<0.001)) at week 12, with improvements observed by week 1. There was a statistically significant improvement in physical function from baseline, measured by HAQ-DI in CZP patients compared with placebo (−0.50 vs −0.19, p<0.001) and more patients treated with CZP 200 mg Q2W and CZP 400 mg achieved an improvement in PsARC at week 24 than placebo (78.3% and 77.0% vs 33.1% (p<0.001)). Sustained improvements were observed in psoriatic skin involvement, enthesitis, dactylitis and nail disease. Higher ACR20 response with CZP was independent of prior TNF inhibitor exposure. No new safety signals were observed.</p></sec><sec><title>Conclusions</title><p>Rapid improvements in the signs and symptoms of PsA, including joints, skin, enthesitis, dactylitis and nail disease were observed across both CZP dosing regimens.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Haroon, M" uniqKey="Haroon M">M Haroon</name></author><author><name sortKey="Kirby, B" uniqKey="Kirby B">B Kirby</name></author><author><name sortKey="Fitzgerald, O" uniqKey="Fitzgerald O">O FitzGerald</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mease, Pj" uniqKey="Mease P">PJ Mease</name></author><author><name sortKey="Gladman, Dd" uniqKey="Gladman D">DD Gladman</name></author><author><name sortKey="Papp, Ka" uniqKey="Papp K">KA Papp</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kane, D" uniqKey="Kane D">D Kane</name></author><author><name sortKey="Stafford, L" 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R" uniqKey="Cook R">R Cook</name></author><author><name sortKey="Lee, K A" uniqKey="Lee K">K-A Lee</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Wilson, E" uniqKey="Wilson E">E Wilson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Antoni, C" uniqKey="Antoni C">C Antoni</name></author><author><name sortKey="Krueger, Gg" uniqKey="Krueger G">GG Krueger</name></author><author><name sortKey="De Vlam, K" uniqKey="De Vlam K">K de Vlam</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kingsley, Gh" uniqKey="Kingsley G">GH Kingsley</name></author><author><name sortKey="Kowalczyk, A" uniqKey="Kowalczyk A">A Kowalczyk</name></author><author><name sortKey="Taylor, H" uniqKey="Taylor H">H Taylor</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Glintborg, B" uniqKey="Glintborg B">B Glintborg</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ritchlin, Ct" uniqKey="Ritchlin C">CT Ritchlin</name></author><author><name sortKey="Gottlieb, Ab" uniqKey="Gottlieb A">AB Gottlieb</name></author><author><name sortKey="Mcinnes, Ib" uniqKey="Mcinnes I">IB McInnes</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>Canada</li><li>Pays-Bas</li><li>États-Unis</li></country></list><tree><country name="États-Unis"><noRegion><name sortKey="Mease, P J" sort="Mease, P J" uniqKey="Mease P" first="P J" last="Mease">P J Mease</name></noRegion><name sortKey="Arledge, T" sort="Arledge, T" uniqKey="Arledge T" first="T" last="Arledge">T. Arledge</name><name sortKey="Deodhar, A A" sort="Deodhar, A A" uniqKey="Deodhar A" first="A A" last="Deodhar">A A Deodhar</name><name sortKey="Fleischmann, R" sort="Fleischmann, R" uniqKey="Fleischmann R" first="R" last="Fleischmann">R. Fleischmann</name></country><country name="Allemagne"><noRegion><name sortKey="Wollenhaupt, J" sort="Wollenhaupt, J" uniqKey="Wollenhaupt J" first="J" last="Wollenhaupt">J. Wollenhaupt</name></noRegion><name sortKey="Hoepken, B" sort="Hoepken, B" uniqKey="Hoepken B" first="B" last="Hoepken">B. Hoepken</name><name sortKey="Stach, C" sort="Stach, C" uniqKey="Stach C" first="C" last="Stach">C. Stach</name><name sortKey="Woltering, F" sort="Woltering, F" uniqKey="Woltering F" first="F" last="Woltering">F. Woltering</name></country><country name="Canada"><noRegion><name sortKey="Khraishi, M" sort="Khraishi, M" uniqKey="Khraishi M" first="M" last="Khraishi">M. Khraishi</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Kielar, D" sort="Kielar, D" uniqKey="Kielar D" first="D" last="Kielar">D. Kielar</name></noRegion></country><country name="Pays-Bas"><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></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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