AMSTERDAM — Reassuring data on the use of etanercept in patients with juvenile idiopathic arthritis are emerging from a multicenter Spanish registry, with significant improvements being seen on all clinical parameters and no serious adverse events being reported, Dr. Inmaculada Calvo said at the annual European Congress of Rheumatology.
Etanercept was approved for the treatment of JIA in 1999, but few phase IV studies have been done evaluating the long-term safety and efficacy of tumor necrosis factor (TNF)-α blockade in these patients, noted Dr. Calvo.
A total of 103 patients have been enrolled in the registry, with follow-up extending as long as 48 months.
Fifty-three of the patients were female, the median patient age was 12.3 years, and the median age at disease onset was 5.6 years. During the 3 years prior to recruitment, 91.6% had undergone treatment with methotrexate but had shown an inadequate response, according to Dr. Calvo of the Hospital Infantil la Fe, Valencia, Spain.
All patients had polyarticular disease, 55.3% were seronegative, and 15.5% had systemic-onset disease.
At the time of analysis, 83 patients (80.6%) had been followed for at least 6 months, 72 (69.9%) had been followed for 12 months, and 49 (47.6%) had been followed for 24 months. In addition, 29 (28.2%) and 15 (14.6%) had been followed for 36 and 48 months, respectively.
No serious adverse events have been observed, and the infections reported were typical for patients of this age (see box). The median number of tender joints and swollen joints decreased from 9.09 to 0.3 and 9.24 to 3.13, respectively, Dr. Calvo wrote in a poster session at the meeting, sponsored by the European League Against Rheumatism.
Physician global assessment decreased from a median of 5.96 to 1.13, and patient global assessment fell from a median of 5.43 to 1.30. The Childhood Health Assessment Questionnaire index also decreased, from a median of 1.61 to 0.44. Laboratory parameters also improved, with the erythrocyte sedimentation rate falling from 43 to 11 mm/h and C-reactive protein level decreasing from 12 to 0.1 mg/L.
Reported Adverse Events Are Few