Adalimumab is safe and effective as both a first- and second-line biologic agent in patients with juvenile idiopathic arthritis, according to data presented by Dr. Gerd Horneff.
Dr. Horneff from the Asklepios Klinik, St. Augustin, Germany, and Dr. Heinrike Schmeling from the Alberta Children’s Hospital, Calgary, analyzed data from 329 children aged 4-18 years with juvenile idiopathic arthritis (JIA) in the German Biologics Register, finding that a high proportion of patients showed a significant response to treatment with adalimumab.
"The results of this study indicate that adalimumab is highly effective as a first and also as a second introduced biological agent resulting in substantial improvements in clinical signs and symptoms in children with juvenile idiopathic arthritis," Dr. Schmeling said in an interview prior to the annual European Congress of Rheumatology.
Dr. Gerd Horneff
Even patients who were using adalimumab as a second or third biologic gained an additional response to adalimumab on top of their responses to previous biologics. The percentage of patients who met the criteria of 30%/50%/70% improvement at last documentation when adalimumab was the first introduced biologic agent was 65%/61%/46%, compared with 73%/65%/48% when adalimumab was initiated after other biologics, the investigators reported.
Around one-third of patients had rheumatoid factor–negative polyarticular JIA, 22.9% had extended oligoarticular JIA, and 25.2% of patients had a history of uveitis.
The median age of onset of disease was 6.7 years, and median age at treatment initiation was 13.8 years, with median disease duration of 5.1 years. ANA positivity was present in 51% of patients and HLB27 positivity in 19.8%. Most patients had been previously treated with methotrexate (92.4%), approximately one-third had received other disease-modifying antirheumatic drugs (DMARDs), and two-thirds had been treated with biologics, mostly etanercept.
Many were also receiving concomitant treatment with NSAIDs (55.3%), steroids (38%), methotrexate (57.8%), and other DMARDs (13%).
However, Dr. Schmeling emphasized that this study was not an attempt to compare adalimumab to other biologic treatments.
While no malignancies were observed during adalimumab treatment, 96 patients reported 220 adverse events, 14 of which were serious. There were also more autoimmune adverse events among patients treated with adalimumab, but Dr. Schmeling said the numbers were too small to draw any conclusions.
Uveitis developed in 18 children while on treatment, 13 of them had a history of uveitis prior to adalimumab initiation. Treatment was discontinued in 61 patients because of inefficacy (9%), adverse events (5%), remission (3%), patient request (9%), and other unspecified reasons (2%).
Disease register is supported by Abbott, Pfizer (Wyeth Pharma), and Roche, Germany. Dr. Schmeling had no financial disclosures. Dr Horneff declared consultancies, speakers bureau engagement, and research support from Abbott, Pfizer, and Roche.