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dc.contributor.authorTam, Hoi Ki Joshua
dc.contributor.authorNash, Peter
dc.contributor.authorRobinson, Philip C
dc.date.accessioned2021-09-01T05:42:52Z
dc.date.available2021-09-01T05:42:52Z
dc.date.issued2021
dc.identifier.issn2578-5745
dc.identifier.doi10.1002/acr2.11312
dc.identifier.urihttp://hdl.handle.net/10072/407481
dc.description.abstractOBJECTIVE: Biological agents have shown markedly different response rates by baseline C-reactive protein (CRP). Here, we determine the response of patients with nonradiographic axial spondyloarthritis (nr-axSpA) to etanercept stratified by their baseline CRP level. METHODS: The EMBARK trial was a phase 3, randomized, double-blind, placebo-controlled study of etanercept in nr-axSpA. The primary endpoint was Assessment of Spondyloarthritis International Society (ASAS) 40 at Week 12, the conclusion of the double-blind phase. It recruited patients who met the ASAS criteria for axial spondyloarthritis, and sacroiliac joint magnetic resonance scans were completed on all patients. In this post hoc analysis, we analyzed outcomes by baseline C-reactive protein (CRP) level of less than 5 mg/L, 5 mg/L to 10 mg/L, and greater than 10 mg/L. The clinical trial outcome data were accessed via the Vivli platform. RESULTS: In the less than 5 mg/L CRP group treated with etanercept, the ASAS20 response, ASAS40 response, Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS-CRP), and ASDAS-ESR (erythrocyte sedimentation rate) outcomes were 49% (P = 0.84), 26% (P = 0.14), 42% (P = 0.002), and 44% (P = 0.006), respectively. In the 5 to 10 mg/L CRP group treated with etanercept, the ASAS20 response, ASAS40 response, ASDAS-CRP, and ASDAS-ESR outcomes were 56% (P = 0.99), 31% (P = 0.40), 56% (P = 0.16), and 50% (P = 0.11), respectively. In the greater than10 mg/L CRP group treated with etanercept, the ASAS20 response, ASAS40 response, ASDAS-CRP, and ASDAS-ESR outcomes were 74% (P = 0.02), 68% (P = 0.003), 82% (P = 0.005), and 50% (P = 0.001), respectively. CONCLUSION: Although there are reduced ASAS20 and ASAS40 response rates in the groups with baseline CRP less than 10 mg/L, there remain clinically relevant responses when the composite outcome measures ASDAS-CRP or ASDAS-ESR were used, and this should be considered when deciding on thresholds for reimbursement.
dc.description.peerreviewedYes
dc.languageeng
dc.publisherWiley
dc.relation.ispartofjournalACR Open Rheumatology
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchcode3202
dc.titleThe Effect of Etanercept in Nonradiographic Axial Spondyloarthritis by Stratified C-Reactive Protein Levels
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationTam, HKJ; Nash, P; Robinson, PC, The Effect of Etanercept in Nonradiographic Axial Spondyloarthritis by Stratified C-Reactive Protein Levels, ACR Open Rheumatology, 2021
dcterms.dateAccepted2021-07-07
dcterms.licensehttps://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2021-08-30T23:18:54Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© 2021 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology. This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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gro.griffith.authorNash, Peter


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