Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: a RCT

Children with juvenile idiopathic arthritis (JIA) are at risk of uveitis. The role of adalimumab (Humira ; AbbVie Inc., Ludwigshafen, Germany) in the management of uveitis in children needs to be determined. To compare the efficacy, safety and cost-effectiveness of adalimumab in combination with methotrexate (MTX) versus placebo with MTX alone, with regard to controlling disease activity in refractory uveitis associated with JIA. This was a randomised (applying a ratio of 2 : 1 in favour of adalimumab), double-blind, placebo-controlled, multicentre parallel-group trial with an integrated economic evaluation. A central web-based system used computer-generated tables to allocate treatments. A cost-utility analysis based on visual acuity was conducted and a 10-year extrapolation by Markov modelling was also carried out. The setting was tertiary care centres throughout the UK. Patients aged 2-18 years inclusive, with persistently active JIA-associated uveitis (despite optimised MTX treatment for at least 12 weeks). All participants received a stable dose of MTX and either adalimumab (20 mg/0.8 ml for patients weighing