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Meet Vishala, a 3-year-old diagnosed with RF+ pJIA,1 and her mother.
Example
'Sometimes I wonder whether we did something wrong2 when she was born. I question everything I did while pregnant – I know it’s ridiculous’.
‘At least we know what it is now,2,3 but we were shocked when we found out Vishala has JIA; we just don’t know how to manage it’.
‘I worry so much that the drugs won't work and about the effect they could have on her.2,3
Worries about future consequences of the therapy is the most commonly reported barrier to adherence in JIA.4,*
Note: This is a hypothetical case for representation purpose only.
From a long-term OLE trial that evaluated 69 patients with pJIA.10,‡
Exposure-adjusted Rates of SAEs and MIIs in Patients Receiving Enbrel® Over 8 Years10
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.
Adapted from Lovell D, et al. 2008.
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.
References:
Please click the Prescribing Information link to view the safety and adverse events information of Enbrel®.
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