Pragmatic randomised controlled trial of very early etanercept and MTX versus MTX with delayed etanercept in RA: the VEDERA trial
Identifieur interne : 000222 ( 2020/Analysis ); précédent : 000221; suivant : 000223Pragmatic randomised controlled trial of very early etanercept and MTX versus MTX with delayed etanercept in RA: the VEDERA trial
Auteurs : Paul Emery [Royaume-Uni] ; Sarah Horton [Royaume-Uni] ; Raluca Bianca Dumitru [Royaume-Uni] ; Kamran Naraghi [Royaume-Uni] ; Désirée Van Der Heijde [Pays-Bas] ; Richard J. Wakefield [Royaume-Uni] ; Elizabeth M A. Hensor [Royaume-Uni] ; Maya H. Buch [Royaume-Uni]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2020.
Abstract
We sought to confirm in very early rheumatoid arthritis (ERA) a much greater superiority (30%) of first-line etanercept+methotrexate (ETN+MTX) over treat-to-target MTX (MTX-TT) than previously reported in ERA (14%); and explore whether ETN following initial MTX secures a comparable response to first-line ETN+MTX.
Pragmatic, open-label, randomised controlled trial of treatment-naïve ERA (≤12 months symptom), Disease Activity Score 28 joint (DAS28)-erythrocyte sedimentation rate (ESR) ≥3.2, rheumatoid factor (RF)+/−anticitrullinated peptide antibody (ACPA) positive or ultrasound power Doppler (PD) if RF and ACPA negative. Subjects were randomised 1:1 to ETN+MTX; or MTX-TT, escalated to ETN if week 24 DAS28-ESR ≥2.6 and intramuscular corticosteroid at protocolised time points. Primary endpoint of week 48 DAS28ESR remission with clinical and imaging secondary endpoints.
We randomised 120 patients, 60 to each arm (71% female, 73% RF/84% ACPA positive, median (IQR) symptom duration 20.3 (13.1, 30.8) weeks; mean (SD) DAS28 5.1 (1.1)). Remission rates with ETN+MTX and MTX-TT, respectively, were 38% vs 33% at week 24; 52% vs 38% at week 48 (ORs 1.6, 95% CI 0.8 to 3.5, p=0.211). Greater, sustained DAS28-ESR remission observed with ETN+MTX versus MTX-TT (42% and 27%, respectively; p=0.035). PD was fully suppressed by week 48 in over 90% in each arm. Planned exploratory analysis revealed OR 2.84, 95% CI 0.8 to 9.6) of achieving remission after 24 weeks of ETN administered first line compared with administered post-MTX.
Compared with remission rates typically reported with first-line tumour necrosis factor inhabitor+MTX versus MTX-TT, we did not demonstrate a larger effect in very ERA. Neither strategy conferred remission in the majority of patients although ultrasound confirmed local inflammation suppression. Poorer ETN response following failure of MTX-TT is also suggested.
NCT02433184
Url:
DOI: 10.1136/annrheumdis-2019-216539
PubMed: 31996367
PubMed Central: 7147179
Affiliations:
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PMC:7147179Le document en format XML
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content-type="city">Leeds</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust</institution>,<addr-line content-type="city">Leeds</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="Horton, Sarah" sort="Horton, Sarah" uniqKey="Horton S" first="Sarah" last="Horton">Sarah Horton</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds</institution>,<addr-line content-type="city">Leeds</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Central Lancashire Moving Well Service, Lancashire and South Cumbria NHS Foundation Trust</institution>,<addr-line content-type="city">Preston</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="Dumitru, Raluca Bianca" sort="Dumitru, Raluca Bianca" uniqKey="Dumitru R" first="Raluca Bianca" last="Dumitru">Raluca Bianca Dumitru</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds</institution>,<addr-line content-type="city">Leeds</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="Naraghi, Kamran" sort="Naraghi, Kamran" uniqKey="Naraghi K" first="Kamran" last="Naraghi">Kamran Naraghi</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds</institution>,<addr-line content-type="city">Leeds</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="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Désirée" last="Van Der Heijde">Désirée Van Der Heijde</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution content-type="department">Department of Rheumatology</institution>,<institution>Leiden University Medical Centre</institution>,<addr-line content-type="city">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="Wakefield, Richard J" sort="Wakefield, Richard J" uniqKey="Wakefield R" first="Richard J" last="Wakefield">Richard J. Wakefield</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds</institution>,<addr-line content-type="city">Leeds</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust</institution>,<addr-line content-type="city">Leeds</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="Hensor, Elizabeth M A" sort="Hensor, Elizabeth M A" uniqKey="Hensor E" first="Elizabeth M A" last="Hensor">Elizabeth M A. Hensor</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds</institution>,<addr-line content-type="city">Leeds</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust</institution>,<addr-line content-type="city">Leeds</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="Buch, Maya H" sort="Buch, Maya H" uniqKey="Buch M" first="Maya H" last="Buch">Maya H. Buch</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds</institution>,<addr-line content-type="city">Leeds</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine & Health, University of Manchester</institution>,<addr-line content-type="city">Manchester</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>NIHR Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Manchester University Foundation Trust</institution>,<addr-line content-type="city">Manchester</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></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="2020">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objectives</title><p>We sought to confirm in very early rheumatoid arthritis (ERA) a much greater superiority (30%) of first-line etanercept+methotrexate (ETN+MTX) over treat-to-target MTX (MTX-TT) than previously reported in ERA (14%); and explore whether ETN following initial MTX secures a comparable response to first-line ETN+MTX.</p></sec><sec><title>Methods</title><p>Pragmatic, open-label, randomised controlled trial of treatment-naïve ERA (≤12 months symptom), Disease Activity Score 28 joint (DAS28)-erythrocyte sedimentation rate (ESR) ≥3.2, rheumatoid factor (RF)+/−anticitrullinated peptide antibody (ACPA) positive or ultrasound power Doppler (PD) if RF and ACPA negative. Subjects were randomised 1:1 to ETN+MTX; or MTX-TT, escalated to ETN if week 24 DAS28-ESR ≥2.6 and intramuscular corticosteroid at protocolised time points. Primary endpoint of week 48 DAS28ESR remission with clinical and imaging secondary endpoints.</p></sec><sec><title>Results</title><p>We randomised 120 patients, 60 to each arm (71% female, 73% RF/84% ACPA positive, median (IQR) symptom duration 20.3 (13.1, 30.8) weeks; mean (SD) DAS28 5.1 (1.1)). Remission rates with ETN+MTX and MTX-TT, respectively, were 38% vs 33% at week 24; 52% vs 38% at week 48 (ORs 1.6, 95% CI 0.8 to 3.5, p=0.211). Greater, sustained DAS28-ESR remission observed with ETN+MTX versus MTX-TT (42% and 27%, respectively; p=0.035). PD was fully suppressed by week 48 in over 90% in each arm. Planned exploratory analysis revealed OR 2.84, 95% CI 0.8 to 9.6) of achieving remission after 24 weeks of ETN administered first line compared with administered post-MTX.</p></sec><sec><title>Conclusions</title><p>Compared with remission rates typically reported with first-line tumour necrosis factor inhabitor+MTX versus MTX-TT, we did not demonstrate a larger effect in very ERA. Neither strategy conferred remission in the majority of patients although ultrasound confirmed local inflammation suppression. Poorer ETN response following failure of MTX-TT is also suggested.</p><p><bold>Trial registration number</bold></p><p>NCT02433184</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name sortKey="Landewe, R" uniqKey="Landewe R">R Landewé</name></author><author><name sortKey="Bijlsma, J" uniqKey="Bijlsma J">J Bijlsma</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nam, Jl" uniqKey="Nam J">JL Nam</name></author><author><name sortKey="Takase Minegishi, K" uniqKey="Takase Minegishi K">K Takase-Minegishi</name></author><author><name sortKey="Ramiro, S" uniqKey="Ramiro S">S Ramiro</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Goekoop Ruiterman, Ypm" uniqKey="Goekoop Ruiterman Y">YPM Goekoop-Ruiterman</name></author><author><name sortKey="De Vries Bouwstra, Jk" uniqKey="De Vries Bouwstra J">JK De 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S">S Hall</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bejarano, V" uniqKey="Bejarano V">V Bejarano</name></author><author><name sortKey="Quinn, M" uniqKey="Quinn M">M Quinn</name></author><author><name sortKey="Conaghan, Pg" uniqKey="Conaghan P">PG Conaghan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Schett, G" uniqKey="Schett G">G Schett</name></author><author><name sortKey="Emery, P" uniqKey="Emery P">P Emery</name></author><author><name sortKey="Tanaka, Y" uniqKey="Tanaka Y">Y Tanaka</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Emery, P" uniqKey="Emery P">P Emery</name></author><author><name sortKey="Kvien, Tk" uniqKey="Kvien T">TK Kvien</name></author><author><name sortKey="Combe, B" uniqKey="Combe B">B Combe</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Smolen, Js" uniqKey="Smolen J">JS Smolen</name></author><author><name 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Durez</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Pays-Bas</li><li>Royaume-Uni</li></country></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name></noRegion><name sortKey="Buch, Maya H" sort="Buch, Maya H" uniqKey="Buch M" first="Maya H" last="Buch">Maya H. Buch</name><name sortKey="Buch, Maya H" sort="Buch, Maya H" uniqKey="Buch M" first="Maya H" last="Buch">Maya H. Buch</name><name sortKey="Buch, Maya H" sort="Buch, Maya H" uniqKey="Buch M" first="Maya H" last="Buch">Maya H. Buch</name><name sortKey="Dumitru, Raluca Bianca" sort="Dumitru, Raluca Bianca" uniqKey="Dumitru R" first="Raluca Bianca" last="Dumitru">Raluca Bianca Dumitru</name><name sortKey="Emery, Paul" sort="Emery, Paul" uniqKey="Emery P" first="Paul" last="Emery">Paul Emery</name><name sortKey="Hensor, Elizabeth M A" sort="Hensor, Elizabeth M A" uniqKey="Hensor E" first="Elizabeth M A" last="Hensor">Elizabeth M A. Hensor</name><name sortKey="Hensor, Elizabeth M A" sort="Hensor, Elizabeth M A" uniqKey="Hensor E" first="Elizabeth M A" last="Hensor">Elizabeth M A. Hensor</name><name sortKey="Horton, Sarah" sort="Horton, Sarah" uniqKey="Horton S" first="Sarah" last="Horton">Sarah Horton</name><name sortKey="Horton, Sarah" sort="Horton, Sarah" uniqKey="Horton S" first="Sarah" last="Horton">Sarah Horton</name><name sortKey="Naraghi, Kamran" sort="Naraghi, Kamran" uniqKey="Naraghi K" first="Kamran" last="Naraghi">Kamran Naraghi</name><name sortKey="Wakefield, Richard J" sort="Wakefield, Richard J" uniqKey="Wakefield R" first="Richard J" last="Wakefield">Richard J. Wakefield</name><name sortKey="Wakefield, Richard J" sort="Wakefield, Richard J" uniqKey="Wakefield R" first="Richard J" last="Wakefield">Richard J. Wakefield</name></country><country name="Pays-Bas"><noRegion><name sortKey="Van Der Heijde, Desiree" sort="Van Der Heijde, Desiree" uniqKey="Van Der Heijde D" first="Désirée" last="Van Der Heijde">Désirée Van Der Heijde</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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