Please consult the LPD for contraindications, warnings, precautions and other important safety information.

Please note: The examples described here are not of actual patients, but fictitious representations of scenarios for which Enbrel® (etanercept) could be considered.

*A barrier assessment tool was used to identify patient and parent-reported adherence barriers across several JIA treatments in 7 rheumatology clinics across the United States. Data were collected from 578 parents and 99 patients (a total of 677 barrier assessments) over the study period.⁴

^†From an OLE study (N=58) that followed an RCT (N=69) in patients with active pJIA who received up to 8 years of continuous treatment with Enbrel^®. SAEs were those occurring during the study period or within 30 days of the last Enbrel® dose. MIIs were defined as infections resulting in the need for intravenous antibiotic therapy or hospitalisation.¹⁰

^‡From an analysis of all pJIA patients aged 2 to 4 years in the German BIKER registry who initiated TNFi treatment with Enbrel^® or adalimumab between January 2001 and March 2015. Given the observational design of the registry, no efficacy comparison between the 2 agents was intended.¹¹

Study design: Lovell DJ, et al. 2008.

This long-term OLE observational trial, which followed an RCT, was conducted to evaluate the safety and efficacy of Enbrel^® in JIA patients for up to 8 years of therapy.¹⁰ Patients with active pJIA were eligible to enrol in the original RCT.¹⁰ The primary efficacy endpoint, which was evaluated in the double-blind study, was the number of patients with disease flares.²²

MTX and other DMARDs were discontinued 4 and 2 weeks, respectively, before enrollment on the RCT. After 1 year in the OLE, patients were allowed to receive MTX at a maximum dose of 10-20 mg/m².

Efficacy was assessed using the ACR Pedi 30/50/70/90/100 criteria for improvement. Other parameters included patient- and physician-reported assessments and laboratory analyses. Safety endpoints included the incidence of SAEs, MIIs and death.¹²

ACR Pedi, American College of Rheumatology Pediatric; AE, adverse event; DMARD, disease-modifying antirheumatic drug; GC, glucocorticoid; JIA, juvenile idiopathic arthritis; MII, medically important infection; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; OLE, open-label extension; pJIA, polyarticular juvenile idiopathic arthritis; RCT, randomised controlled trial; RF+, rheumatoid factor positive; RF−, rheumatoid factor negative; SAE, serious adverse event; SmPC, summary of product characteristics; TNFi, tumour necrosis factor inhibitor.