Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study

Abstract

ABSTRACT

Effects of Long‐Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104‐Week Results From a Randomized, Placebo‐Controlled Study

“…In the initial double‐blind period of the phase IIIb, randomized, placebo‐controlled EMBARK study (http://ClinicalTrials.gov identifier: NCT01258738), patients with early, active, NSAID‐resistant nonradiographic axial SpA achieved significant improvement in clinical signs and symptoms and markers of inflammation (i.e., high sensitivity C‐reactive protein [CRP] levels and sacroiliac joint [SIJ] and spinal inflammation assessed by MRI) after 12 weeks of etanercept therapy . Patients who received etanercept after week 12 in the open‐label period demonstrated improvement in clinical outcomes and markers of inflammation that was sustained to 48 weeks . In this report, we present evidence on treatment response, changes in objective signs of inflammation, and safety from patients treated with etanercept up to week 104 of the open‐label treatment period, and examine possible relationships between clinical and MRI remission in nonradiographic axial SpA.…”

Manufacturing history of etanercept (Enbrel®): Consistency of product quality through major process revisions

“…With its approval by the European Medicines Agency (EMA) in 2000, 1 etanercept (ETN) (Enbrel Ò ) was one of the first TNF inhibitors to be approved in the European Union (EU) for the treatment of RA. ETN has since been approved for the treatment of other autoimmune diseases, 2 including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, 3 and non-radiographic axial spondyloarthritis, 4 as well as polyarticular-course juvenile idiopathic arthritis (JIA), and the JIA categories extended oligoarthritis, enthesitis-related arthritis, and psoriasis arthritis. 5 ETN is a dimeric fusion protein consisting of the extracellular domain of human TNF receptor (TNFRII orp75), linked to the crystallizable fragment (Fc) of human type 1 immunoglobulin G (IgG1).…”

Discordant inflammatory changes in the apophyseal and sacroiliac joints: serial observations in enthesitis-related arthritis

“…[3][4][5][6] A subset of children with sacroiliitis will progress to spondylitis as adults, which is characterized by back pain, stiffness and eventual fusion of the vertebra. 3 Early treatment in spondyloarthritis may have a disease-modifying effect and consequently improve outcomes; 7 but, if treatment is inadequate, then outcomes are poor in terms of physical health, pain and physical activity. 4 MRI is commonly used in ERA and has traditionally focused on the early detection of inflammation at the SIJs.…”