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

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 At week 24, patients who achieved inactive disease qualified for Period 2 and were withdrawn from ETN treatment for 40 weeks.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.