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

Abstract

Objective:Etanercept monotherapy has been studied and approved for treatment of polyarticular juvenile idiopathic arthritis (JIA). The following study evaluates the safety and efficacy of combination therapy of etanercept and methotrexate compared to etanercept monotherapy in JIA.Methods:We perfomed an open, non-randomised study on patients who had previously failed to respond to at least one disease-modifying antirheumatic drug (DMARD). A total of 722 patients with JIA in whom at least 1 item of follow-up data was recorded were identified; of these, 118 patients treated with further slow acting drugs were excluded. In all, 504 patients were treated with a combination of etanercept and methotrexate. A total of 100 patients treated with etanercept only were in the control group. Efficacy was calculated using the American College of Rheumatology paediatric scores for 30, 50 and 70% improvement (PedACR30/50/70). Adverse events (AEs) and serious adverse events (SAEs) were reported.Results:After 12 months 55 patients in the monotherapy group and 376 patients in the etanercept and 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 and methotrexate group and 70%/63%/45% of patients of the etanercept monotherapy group achieved PedACR30/50/70 scores, respectively (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 (95% CI 1.2 to 3.5). In total, 25 infectious and 23 non-infectious SAEs including 3 malignancies occurred in the etanercept and methotrexate group, and 1 infectious and 3 non-infectious SAEs occurred in the single etanercept group.Conclusions:The patients’ disease activity improved during etanercept monotherapy and etanercept and methotrexate combination therapy. Tolerability in both treatment groups was comparable.

Uveitis Events During Adalimumab, Etanercept, and Methotrexate Therapy in Juvenile Idiopathic Arthritis: Data From the Biologics in Pediatric Rheumatology Registry

“…Written informed consent was obtained from all parents and eligible patients, and data were collected in pseudonymized form as approved by the ethics committee. Since the year 2000, patients newly starting on-label treatment with ETA, and since 2008 with ADA, were included in the registry (16)(17)(18). Patients without exposure to a biologic agent but starting with MTX were recruited as a control cohort from 2005 to 2011, until the target of 1,500 patients was reached.…”

Improvement of functional ability in children with juvenile idiopathic arthritis by treatment with etanercept

“…The introduction of biologics like etanercept had a major impact on the outcome of patients with polyarticular JIA. The safety and the efficiency of etanercept had been proved in open and controlled studies as well as in long term studies (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13).…”

Risk of malignancy in children with juvenile idiopathic arthritis not treated with biologic agents

“…Recently, concerns have been raised about the possibility of an increased risk of cancer in JIA patients treated with such agents (5)(6)(7)(8)(9). The increased cancer risk in adult RA is believed to be partly related to the immune dysregulation that characterizes the disease.…”