Efficacy and safety of oral and parenteral methotrexate therapy in children with juvenile idiopathic arthritis. An observational study with patients of the German Methotrexate Registry
Arthritis Care & Research , 06/08/2012
Klein A et al. – Inthis retrospective analysis parenteral MTX was not superior to oral administration regarding efficacy and tolerability.
Inclusion criteria were diagnosis of JIA, MTX treatment for at least 6 months, a consistent route of administration of MTX and no previous or concomitant treatment with biologics.
Efficacy was measured by PedACR criteria.
Primary outcome was efficacy defined as the number of patients reaching PedACR 30 criteria after 6 months of treatment.
Secondary outcome criteria were the PedACR50 and 70 criteria at 6 and 12 months of treatment.
Analyses were performed with the intention to treat population.
Of the 411 eligible patients 259(63)%received oral and 152(37%)subcutaneous MTX.
In both patient groups a comparable weekly dosage of MTX(0.4 mg/kg vs. 0.42 mg/kg)was used, a comparable number of patients received concomitant steroids.
Primary outcome: In both treatment groups a comparably high number of patients showed a clinical response according to the PedACR 30 score after 6 months of treatment(73% vs. 72%, p=0.87). 22% of patients with oral and 27% with subcutaneous therapy had at least one documented adverse event.
Discontinuation of treatment was observed equally frequent in both groups while significantly more patients with subcutaneous application discontinued MTX because of adverse events(11% vs. 5%, p=0.02).
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