Abbott has announced that the European Commission approved Humira (adalimumab) in combination with methotrexate (MTX) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) in children and adolescents ages four-to-12 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
The approval is based on data from a 48-week study and a subsequent open-label extension that evaluated efficacy and safety of Humira in children with polyarticular JIA. Previously, Humira was approved for adolescents ages 13-to-17 with JIA.
JIA is the most common chronic rheumatic disease in adolescents and children with onset before age 16. Typical symptoms include stiffness when awakening, limping, and joint swelling. While it was once believed that most children eventually outgrow JIA, it is now known that between 25 and 70 per cent of children with JIA will still have active disease into adulthood.
“The pain and inflammation caused by juvenile idiopathic arthritis can be debilitating for some children, keeping them from active play and every day activities. For these patients and their parents, early intervention is key to managing the symptoms associated with the disease,” said Dr Orla Killeen, consultant rheumatologist, Our Lady’s Children’s Hospital, Dublin.
The 48-week study included 171 children (four-to-17 years of age) with polyarticular JIA. In the first part of this study, two groups of patients - those taking MTX and those not taking MTX – received open-label Humira (up to a maximum of 40 mg) every other week for 16 weeks. Patient responses were measured using the American College of Rheumatology Paediatric (ACR Pedi) 30 score, which represents a 30 per cent or greater improvement in JIA signs and symptoms. Children who showed a positive clinical response and entered the second part of the study (n=133) were randomised to receive either Humira (up to a maximum of 40 mg) or placebo every other week in a blinded fashion for an additional 32 weeks, or until disease flare.
In this second part of the 48-week study, significantly fewer patients receiving Humira demonstrated disease flare compared to patients on placebo, both without MTX (43 per cent vs 71 per cent) and with MTX (37 per cent vs 65 per cent). Additionally, more patients treated with Humira continued to show ACR Pedi 30/50/70 responses at week 48 compared to placebo. After 48 weeks in the study or at time of disease flare, 128 patients entered the open-label extension (OLE) study where they received Humira (up to a maximum of 40 mg) every other week.
The paediatric ACR 30/50/70/90 responses in patients who received Humira throughout the study were maintained in the OLE phase for up to six years. Overall 19 subjects were treated six years or longer, of which 11 were of the baseline age group four-to-12 and eight of the baseline age group 13-to-17. n
