Objective: Etanercept monotherapy has been studied and approved for treatment of polyarticular JIA. The following study evaluates the safety and efficacy of combination therapy of Etanercept&Methotrexate compared to Etanercept monotherapy in JIA.
Patients and methods: This is an open, non-randomized study on patients who failed to respond to at least 1 DMARD. 722 JIA patients in whom at least 1 item of follow-up data was recorded were identified. 118 patients treated with further slow acting drugs were excluded. 504 patients were treated with a combination of Etanercept&Methotrexate. 100 patients treated with Etanercept only were in the control group. Efficacy was calculated using the PedACR30/50/70-scores. Adverse events and serious adverse events were reported.
Results: After 12 months 55 patients in the monotherapy group and 376 patients in the Etanercept&Methotrexate group were available for comparison. For the intention-to-treat analysis 65 patients discontinuing treatment prematurely were included. All activity parameters decreased significantly in both treatment groups. After 12 months 81%/74%/62% of patients of the Etanercept&Methotrexate group and 70%/63%/45% of patients of the Etanercept monotherapy group achieved PedACR30/50/70 scores (p<0.05 for PedACR30, p<0.01 for PedACR70). The likelihood of achieving a PedACR70 increased with combination therapy with an odds ratio of 2.1 (CI 1.2-3.5). 25 infectious and 23 non-infectious SAE including three malignancies occurred in the Etanercept&Methotrexate group, 1 infectious and 3 non-infectious SAE in the single Etanercept group.
Conclusions: The patients’disease activity improved during both Etanercept monotherapy and Etanercept&Methotrexate combination therapy. Tolerability in both treatment groups was comparable.