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Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study
D J Lovell1, E H Giannini, A Reiff
1Children's Hospital Medical Center, Cincinnati, OH 45229-3039, USA.
Insights
Etanercept significantly improved polyarticular juvenile rheumatoid arthritis in children. This tumor necrosis factor receptor therapy demonstrated good tolerability and efficacy in pediatric patients.
Area of Science:
- Rheumatology
- Pediatric Rheumatology
- Immunology
Background:
- Juvenile rheumatoid arthritis (JRA) is a chronic autoimmune disease affecting children.
- Methotrexate is a common treatment for JRA, but some patients show inadequate response or intolerance.
- Etanercept, a tumor necrosis factor receptor fusion protein, offers a potential therapeutic alternative.
Purpose of the Study:
- To evaluate the safety and efficacy of etanercept in pediatric patients with polyarticular JRA.
- To assess etanercept's effectiveness in children unresponsive or intolerant to methotrexate.
- To compare etanercept's long-term efficacy against placebo in a double-blind setting.
Main Methods:
- A multicenter, open-label trial involving 69 children (4-17 years) treated with etanercept (0.4 mg/kg twice weekly).
- Responders entered a 4-month double-blind, placebo-controlled phase, receiving either etanercept or placebo.
- Disease response defined by a ≥30% improvement in at least three of six disease activity indicators.
Main Results:
- 74% of patients responded to etanercept in the open-label phase.
- In the double-blind study, significantly fewer patients on etanercept experienced disease flare (28%) compared to placebo (81%) (P=0.003).
- Median time to flare was over 116 days with etanercept versus 28 days with placebo (P<0.001); adverse events were similar between groups.
Conclusions:
- Etanercept provides significant clinical improvement for children with active polyarticular JRA.
- Etanercept is a well-tolerated and effective treatment option for pediatric patients with JRA.
- The study supports etanercept's role in managing JRA in patients with prior methotrexate treatment failure.
Background:
We evaluated the safety and efficacy of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein, in children with polyarticular juvenile rheumatoid arthritis who did not tolerate or had an inadequate response to methotrexate.
Methods:
Patients 4 to 17 years old received 0.4 mg of etanercept per kilogram of body weight subcutaneously twice weekly for up to three months in the initial, open-label part of a multicenter trial. Those who responded to treatment then entered a double-blind study and were randomly assigned to receive either placebo or etanercept for four months or until a flare of the disease occurred. A response was defined as an improvement of 30 percent or more in at least three of six indicators of disease activity, with no more than one indicator worsening by more than 30 percent.
Results:
At the end of the open-label study, 51 of the 69 patients (74 percent) had had responses to etanercept treatment. In the double-blind study, 21 of the 26 patients who received placebo (81 percent) withdrew because of disease flare, as compared with 7 of the 25 patients who received etanercept (28 percent) (P=0.003). The median time to disease flare with placebo was 28 days, as compared with more than 116 days with etanercept (P<0.001). In the double-blind study, there were no significant differences between the two treatment groups in the frequency of adverse events.
Conclusions:
Treatment with etanercept leads to significant improvement in patients with active polyarticular juvenile rheumatoid arthritis. Etanercept is well tolerated by pediatric patients.
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