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.Methods
- 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).