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Review
. 2004 Dec;63(12):1638-44.
doi: 10.1136/ard.2003.014886. Epub 2004 Apr 28.

The German Etanercept Registry for Treatment of Juvenile Idiopathic Arthritis

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Free PMC article
Review

The German Etanercept Registry for Treatment of Juvenile Idiopathic Arthritis

G Horneff et al. Ann Rheum Dis. .
Free PMC article

Abstract

Objective: To describe a registry set up to monitor children treated with etanercept in Germany and Austria.

Methods: Giannini's criteria, duration of morning stiffness, number of swollen, tender and contracted joints, adverse events, and reasons for discontinuation were assessed.

Results: 322 patients with juvenile idiopathic arthritis (JIA) and 12 additional patients with non-JIA rheumatic diagnoses were included. Therapeutic efficacy was observed from one month after treatment was started. The number of patients with significant improvement and the degree of improvement increased during the first year. The mean (SD) number of tender and swollen joints decreased from 9 (9) and 8.4 (9) to 3.0 (6.5) and 4.5 (7) after one month, and to 2.2 (5.5) and 3.3 (5.5) after three months; morning stiffness decreased from 45 (65) minutes to 12 (30) and 7 (19) after one and three months (p<0.001 for all). Using Gianinni's criteria of 30%, 50%, and 70% improvement, a therapeutic response in JIA patients was achieved in, respectively, 66%, 54%, and 30% after one month, 78%, 61%, and 38% after three months, and 83%, 72%, and 52% after six months. Therapeutic efficacy was lower in patients with systemic onset arthritis. Overall tolerability was good: in 592 patient treatment-years there were 69 reports of adverse events in 56 patients, including one CNS demyelination. There were no opportunistic infections or lupus-like reactions. Treatment was discontinued in 53 JIA patients, in 25 because of lack of efficacy.

Conclusion: Etanercept treatment was safe and led to a significant improvement in most JIA patients resistant to conventional treatment.

Figures

Figure 1
Figure 1
Incidence of 30%, 50%, and 70% improvement in patients with juvenile idiopathic arthritis (JIA) receiving etanercept treatment, according to the core set criteria. Data on 275 patients are included. Analysis was undertaken by LCOF (last observation carried forward). (A) 48 JIA patients with systemic onset and a treatment duration of at least two months. Four patients were excluded because treatment had been discontinued earlier; in eight patients month 1 data were missing; eight patients with systemic onset JIA discontinued treatment prematurely. At last report, a 30%, 50%, or 70% response level was reported in one, one, and two patients, respectively, while four were non-responders. (B) 222 JIA patients with non-systemic-onset. In 32 patients month 1 data were missing. The number of non-systemic-onset JIA patients who met the 30%, 50% and 70% response criteria exceeded the number of systemic onset JIA patients who met the core set criteria. Twenty four of 222 patients with non-systemic-onset JIA discontinued prematurely. At last report a 30%, 50%, or 70% response level was reported in four, six, and eight patients, while only six were non-responders.

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