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Safety and efficacy of combination of Etanercept and Methotrexate compared to treatment with Etanercept only in patients with juvenile idiopathic arthritis (JIA). Preliminary data from the German JIA Registry
  1. G Horneff (g.horneff{at}asklepios.com)
  1. Asklepios Clinic Sankt Augustin, Germany
    1. F De Bock (f.debock{at}asklepios.com)
    1. Asklepios Clinic Sankt Augustin, Germany
      1. I Foeldvari (foeldvari{at}uke.uni-hamburg.de)
      1. Office Paediatric Rheumatology Hamburg, Germany
        1. H J Girschick (girschick_h{at}kinderklinik.uni-wuerzburg.de)
        1. University Wuerzburg, Guyana
          1. H Michels (michels.garmisch-partenkirchen{at}t-online.de)
          1. Deutsches Kinderrheumazentrum Garmisch-Partenkirchen, Germany
            1. D Moebius (d.moebius{at}ctk.de)
            1. Carl-Thiem Klinikum Cottbus, Germany
              1. H Schmeling (heinrike.schmeling{at}medizin.uni-halle.de)
              1. University Halle, Germany

                Abstract

                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.

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