June 12, 2009
Studies Confirm The Value Of Etanercept Therapy In Treating Juvenile Idiopathic Arthritis
Three new studies have individually shown the anti-TNF (tumour necrosis factor) therapy etanercept to be effective, with a good safety profile, in children under four years of age with juvenile idiopathic arthritis (JIA), and associated with improved Health-Related Quality of Life (HRQoL) in a substantial proportion of children with JIA. The data are being presented at the Paediatric Rheumatology European Society Congress (PReS) 2009, a joint congress with the 2009 Congress of the European League Against Rheumatism (EULAR) in Copenhagen, Denmark.
The first study, conducted in Italy, showed entanercept to be effective, with a good safety profile, in children under four years of age (an as yet unlicensed patient population for the treatment). Thirty-three patients under four years of age with unresponsive JIA (24 female, 9 male) were treated with etanercept for an average of 23 months. After the first 6 months of treatment, 82% achieved the ACR Pedi 30* response and 48% achieved the ACR Pedi 70* response. There was a low rate of mild adverse events, whilst one patient temporarily suspended treatment following hospitalisation for an infection.
The second study, conducted in The Netherlands, from the Arthritis and Biological in Children (ABC) project, observed impressive improvements in the Health-Related Quality of Life (HRQoL) of 53 patients with previously refractory (unresponsive) JIA in seven Dutch centres during entanercept use of at least 27 months. These comprised both disease-specific improvements (inflamed joints, functional impairment, erythrocyte sedimentation rate (ESR), a laboratory marker of inflammation) (p<0.001) and all generic HRQoL outcomes impaired by JIA (including pain, movement and dexterity) (p<0.05).
The third study, also from The Netherlands ABC-project, showed that a substantial 57% of non-responders to etanercept at three months (12 patients from 21 non-responders of a total of 179 JIA patients; average age of 5.8 years) who continued with the treatment eventually responded. The researchers in this study thereby suggest extending the use of etanercept in non-responding patients beyond the commonly recommended three-month therapy window to achieve higher response rates in JIA patients.
* The American College of Rheumatology (ACR) pediatric criteria assess patient response to a treatment. An ACR Pedi 30 response represents a >30% improvement in JIA signs and symptoms, such as the number of swollen joints with loss of motion, assessment of pain and level of disability. ACR Pedi 50 represents a >50% improvement, and ACR Pedi 70 represents a >70% improvement.
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