dc.contributor.author | van den Bosch, Filip | |
dc.contributor.author | Wei, James Cheng-Chung | |
dc.contributor.author | Nash, Peter | |
dc.contributor.author | Deodhar, Atul | |
dc.contributor.author | Blanco, Francisco J | |
dc.contributor.author | Bukowski, Jack F | |
dc.contributor.author | Pedersen, Ronald | |
dc.contributor.author | Vlahos, Bonnie | |
dc.date.accessioned | 2021-01-13T04:59:34Z | |
dc.date.available | 2021-01-13T04:59:34Z | |
dc.date.issued | 2019 | |
dc.identifier.issn | 0003-4967 | |
dc.identifier.doi | 10.1136/annrheumdis-2019-eular.1931 | |
dc.identifier.uri | http://hdl.handle.net/10072/400994 | |
dc.description.abstract | Background 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 At week 24, patients who achieved inactive disease qualified for Period 2 and were withdrawn from ETN treatment for 40 weeks.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.language | English | |
dc.publisher | BMJ Publishing Group Ltd | |
dc.relation.ispartofconferencename | Annual European Congress of Rheumatology (EULAR) | |
dc.relation.ispartofconferencetitle | Annals of the Rheumatic Diseases | |
dc.relation.ispartofdatefrom | 2019-06-12 | |
dc.relation.ispartofdateto | 2019-06-15 | |
dc.relation.ispartoflocation | Madrid, Spain | |
dc.relation.ispartofpagefrom | 896 | |
dc.relation.ispartofpageto | 897 | |
dc.relation.ispartofissue | Suppl 2 | |
dc.relation.ispartofvolume | 78 | |
dc.subject.fieldofresearch | Clinical sciences | |
dc.subject.fieldofresearch | Immunology | |
dc.subject.fieldofresearchcode | 3202 | |
dc.subject.fieldofresearchcode | 3204 | |
dc.subject.keywords | Science & Technology | |
dc.subject.keywords | Life Sciences & Biomedicine | |
dc.subject.keywords | Rheumatology | |
dc.title | 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 | |
dc.type | Conference output | |
dc.type.description | E3 - Conferences (Extract Paper) | |
dcterms.bibliographicCitation | van 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.updated | 2021-01-13T04:53:41Z | |
gro.hasfulltext | No Full Text | |
gro.griffith.author | Nash, Peter | |