Background Adalimumab is a fully human anti-TNF monoclonal antibody approved for the treatment of resistant polyarticular juvenile idiopathic arthritis at a dosage of 24 mg/kg/m2. every other week in children below 13 years and 40mg eow. for children older than 13 years.
Objectives To report the experience of treatment with Adalimumab in a large number of JIA patients enrolled in the German JIA BIKER registry.
Methods Patients with JIA with at least the baseline and one follow up visit upon adalimumab were included in the analysis. Efficacy was assessed using single activity parameters and the PedACR30/50 and 70 criteria. Tolerability was assessed by adverse event reporting.
Results Until 2011 December 31, 123 patients with JIA have been recruited, 67% were females. JIA subgroup distribution was as following: systemic onset JIA (soJIA) 4 (3.3%), seronegative polyarthritis 38 (30.9%), seropositive polyarthritis 13 (10.6%), persistent oligoarthritis 12 (9.8%), extended oligoarthritis 31 (25.2%), enthesitis associated arthritis 16 (13%), psoriasisarthritis 8 (6.5%), unclassified arthritis 1 (0.8%). The most frequent accompanying diagnosis was of course uveitis in 20 pts (16%). The mean (median) disease duration before start of treatment with ADA was 6.8 (5.3) years, the age at start of treatment mean (median) was 13.6 (15) years. The initial concomitant treatment consisted of NSAIDs in 63.4%, oral corticosteroids in 48.8%, MTX in 48.8% and other DMARDs in 17%.Improvement was demonstrable by a marked decrease of single disease activity indicators and a high rate of responders according to the PedACR 30/50/70 criteria (table). No new safety signals were observed. There were 42 adverse events in 24 patients, three were serious (diabetes mellitus, anxiety disorder, sensitive palsy). Opportunistic infections or malignancies were not observed in this cohort.
Conclusions The establishment of biological registries in rheumatic diseases, especially for children has already provided additional data to controlled trials. In this cohort of JIA patients out of the clinical practice treated with adalimumab high responder rates were observed. Moreover, all disease activity indicators showed a marked decrease upon treatment.
Disclosure of Interest T. Schmalbach: None Declared, G. Horneff Grant/Research support from: Pfizer, Abbott