Background Since Adalimumab has been approved for the polyarticular course of juvenile idiopathic arthritis (JIA) for ages 4 to 18 in 2008, children treated with Adalimumab have been monitored prospectively in the German Biologics Register (BiKeR).
Objectives To evaluate the efficacy and safety in JIA patients treated with Adalimumab.
Methods Baseline demographics, clinical characteristics and disease activity parameters have been documented. Efficacy was determined using the PedACR 30/50/70 response criteria. Safety assessments were based on adverse events reports from the primary responsible physician.
Results 329 patients with a total of 427visits were identified (305 total patient-years). 238 (72%) were females. The median age at JIA onset was 6.7 (STD (standard deviation) 4.6, range 0.14-15.9). At treatment initiation the median age was 13.8 years (STD 4.1) and the median disease duration 5.1 years (STD 4.0). ANA positivity has been found in 51%, HLB27 positivity in 19.8%. The most frequent included JIA categories were rheumatoid factor negative polyarticular JIA with 34.3% and extended oligoarticular JIA with 22.9%. 22% of patients had a history of Uveitis.
Prior treatment with Adalimumab, 92.4% of children have been treated with Methotrexate (MTX), 35.6% with other disease-modifying antirheumatic drugs (DMARDs) and 63.3% with biologics (60% of them with Etanercept). Concomitant treatment consisted of nonsteroidal anti-inflammatory drugs (NSAIDs) in 55.3%, steroids in 38%, MTX in 57.8% and other DMARDs in 13%.
A high proportion of patients showed a significant response to treatment. The percentage of patients who met the criteria of 30%/50%/70% improvement at last documentation when Adalimumab was the first introduced biological agent was 65%/61%/46% compared to 73%/65%/48% when Adalimumab was initiated after failing to another biologics.
96 patients experienced 220 adverse events (72 per 100 patient-years). 14 of them were reported as serious (4.6 per 100 patient-years). No malignancies were observed during Adalimumab exposure. 18 children suffered from uveitis while on treatment, 13 of them had a history of uveitis prior Adalimumab initiation. One patient developed diabetes mellitus, one Crohn’s disease and three psoriasis. Treatment has been discontinued in 61 patients for the following reasons: Inefficacy 9%, adverse events 5%, remission 3.0%, patients wish 9, others 2%.
Conclusions Adalimumab appears to be highly effective as a first and also as a second introduced biological agent. The treatment is safe and comparable with other biologics used in JIA. Few patients discontinued due to intolerance or inefficacy.
Acknowledgements This study would not have been possible without the collaboration of numerous German and Austrian pediatric rheumatologists, patients and their parents.
The German Registry is supported by Abbott, Pfizer (Wyeth Pharma) and Roche, Germany.
Disclosure of Interest H. Schmeling: None Declared, G. Horneff Grant/research support from: Abbott, Pfizer, Roche, Consultant for: Abbott, Pfizer, Roche, Speakers bureau: Abbott, Pfizer, Roche