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dc.contributor.authorvan den Bosch, Filip
dc.contributor.authorWei, James Cheng-Chung
dc.contributor.authorNash, Peter
dc.contributor.authorDeodhar, Atul
dc.contributor.authorBlanco, Francisco J
dc.contributor.authorBukowski, Jack F
dc.contributor.authorPedersen, Ronald
dc.contributor.authorVlahos, Bonnie
dc.date.accessioned2021-01-13T04:59:34Z
dc.date.available2021-01-13T04:59:34Z
dc.date.issued2019
dc.identifier.issn0003-4967
dc.identifier.doi10.1136/annrheumdis-2019-eular.1931
dc.identifier.urihttp://hdl.handle.net/10072/400994
dc.description.abstractBackground Etanercept (ETN) is efficacious in patients with non-radiographic axial spondyloarthritis (nr-axSpA).1 However, little is known2 about the effect of ETN withdrawal in patients with nr-axSpA who achieved a significant clinical response. Objectives The primary objective of this ongoing, 3-period study is to estimate the proportion of patients with nr-axSpA who experienced a flare (Ankylosing Spondylitis Disease Activity Score with erythrocyte sedimentation rate [ASDAS-ESR] ≥2.1) within 40 weeks post-ETN withdrawal, after achieving inactive disease (ASDAS with C-reactive protein [ASDAS-CRP] <1.3). Here, we report results of the 24-week Period 1, whose goal was to generate a population of ETN-treated patients with inactive disease. Methods RE-EMBARK (NCT02509026) is a multicenter, open-label trial in 18-50-year-old patients with active nr-axSpA (defined as fulfillment of Assessment in Spondyloarthritis International Society [ASAS] criteria, but not modified New York criteria, plus ASDAS-CRP ≥2.1), with an inadequate response to ≥2 nonsteroidal anti-inflammatory drugs (NSAIDs), who were on a stable NSAID dose for ≥2 weeks. In Period 1, all patients received ETN (50 mg/week) plus NSAID for 24 weeks. At week 24, patients who achieved inactive disease qualified for Period 2 and were withdrawn from ETN treatment for 40 weeks. In Period 3, patients who experience a flare during Period 2 will be retreated with ETN for 12 weeks. Efficacy outcomes for Period 1 included the proportions of patients achieving inactive disease and 20% and 40% improvements in ASAS disease activity (ASAS20 and ASAS40), as well as the changes from baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores for the sacroiliac joint (SPARCC-SIJ) and the spine (SPARCC-Spine). Efficacy analyses presented here were performed on the observed cases.
dc.languageEnglish
dc.publisherBMJ Publishing Group Ltd
dc.relation.ispartofconferencenameAnnual European Congress of Rheumatology (EULAR)
dc.relation.ispartofconferencetitleAnnals of the Rheumatic Diseases
dc.relation.ispartofdatefrom2019-06-12
dc.relation.ispartofdateto2019-06-15
dc.relation.ispartoflocationMadrid, Spain
dc.relation.ispartofpagefrom896
dc.relation.ispartofpageto897
dc.relation.ispartofissueSuppl 2
dc.relation.ispartofvolume78
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchImmunology
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode3204
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsRheumatology
dc.titleEtanercept Treatment in patients with non-radiographic axial spondyloarthritis and an inadequate response to nonsteroidal anti-inflammatory drugs: Period 1 results from the re-embark trial
dc.typeConference output
dc.type.descriptionE3 - Conferences (Extract Paper)
dcterms.bibliographicCitationvan den Bosch, F; Wei, JC-C; Nash, P; Deodhar, A; Blanco, FJ; Bukowski, JF; Pedersen, R; Vlahos, B, Etanercept Treatment in patients with non-radiographic axial spondyloarthritis and an inadequate response to nonsteroidal anti-inflammatory drugs: Period 1 results from the re-embark trial, Annals of the Rheumatic Diseases, 2019, 78 (Suppl 2), pp. 896-897
dc.date.updated2021-01-13T04:53:41Z
gro.hasfulltextNo Full Text
gro.griffith.authorNash, Peter


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