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Long-term PHARMacovigilance for Adverse effects in Childhood arthritis focussing on Immune modulatory drugs

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Controlling childhood arthritis without serious side-effects

To address rising concerns regarding a new class of anti-inflammatory medications used for children, an international study investigated their side-effects over time.

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Juvenile idiopathic arthritis (JIA) is a group of autoimmune disorders characterised by chronic joint inflammation, which first appears in childhood and early adolescence. Development of a new class of medications to selectively inhibit inflammation and tissue damage opened a new era in the treatment of inflammatory diseases. However, recent evidence suggested that administration of these immunomodulators, called biologics, could be associated with adverse and often serious side-effects. A multidisciplinary consortium conducted a large international study leading to the safer and more effective use of biologics for JIA. The EU-funded PHARMACHILD (Long-term pharmacovigilance for adverse effects in childhood arthritis focussing on immune modulatory drugs) project evaluated side-effects of biologics on a large international cohort of JIA patients. The project used extensive data from international organisations and national registries in order to identify the risk factors for developing adverse effects to biologics. PHARMACHILD analysed and finalised data from over 10 000 patients from more than 100 participating European paediatric rheumatology centres. More than half of the patients were followed for nearly five years. No increased risk was found for malignancies in the JIA population, compared to a healthy childhood population. The scientists registered a 6.3 times higher incidence rate of inflammatory bowel disease in the JIA population when compared to healthy children. However, about 80 % of patients did not experience any moderate or serious adverse events during a follow-up of 4.9 years. Over 1 000 samples (blood and joint fluid) were collected in a biomaterial bank and analysed. Scientists found that serum concentrations of a specific protein correlate with response to biologicals and disease activity. PHARMACHILD introduced a novel and additional measurement for monitoring anti-inflammatory treatment of individual patients with JIA. This novel parameter allows for the first time individual adaptation of immune-suppressive treatment in JIA to avoid overtreatment and reduce long-term side-effects. The results of PHARMACHILD will enable safer use of biologics in children and young adults.


Childhood arthritis, juvenile idiopathic arthritis, inflammatory diseases, biologics, pharmacovigilance

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