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Etanercept May Provide Benefit for Patients With Juvenile Rheumatoid Arthritis

NEW YORK -- May 9, 2008 -- Study results published in the May 9 issue of Arthritis & Rheumatism support the potential of etanercept therapy to give children with juvenile rheumatoid arthritis (JRA) the promise of a better quality of life as adults.

Toward that goal, the Pediatric Rheumatology Collaborative Study Group -- comprised of more than 70 paediatric rheumatology centres in the United States and Canada -- has been conducting a trial of etanercept in JRA patients for more than 8 years.

To evaluate the long-term therapeutic value of etanercept, the study group began with a randomised, controlled trial, focusing on 69 patients with JRA between the ages of 4 and 17 years. Treatment with methotrexate and other disease-modifying antirheumatic drugs was discontinued a minimum of 2 weeks before enrolment, while maintaining a low-dose regimen of corticosteroids or nonsteroid anti-inflammatory drugs was allowed.

Patients received injections of etanercept based on body weight, with a maximum weekly dosage of 50 mg. The trial was extended beyond 1 year, so participants were permitted to add low-dose methotrexate if recommended by their physician. At every 3 months during the first year of the extension phase and then every 4 to 6 months during the following years, participants were assessed for improvement in overall disease status using the American College of Rheumatology Pediatric (ACR Pedi) criteria as well as evaluated for changes in joint inflammation, mobility, pain, ability to perform routine daily tasks, and C-reactive protein level.

Patients also were monitored for frequency of serious adverse events, such as those that required hospitalisation, resulted in prolonged incapacity, or death. Medically important infections, defined as those that required treatment with intravenous antibiotics, were monitored.

There were 58 patients with JRP -- 84% of the participants in the randomised, controlled trial enrolled in the long-term extension trial and received weekly treatment for a total of 318 patient-years of etanercept exposure.

Most patients were female (67%) and white (74%), and all had taken methotrexate prior to the study. At baseline, the mean age of the patients was 10 years and the mean duration of disease was 5.9 years. Forty-two of these patients (72%) entered the fourth year of continuous etanercept treatment, and 26 patients (45%) entered the eighth year.

The researchers found that 16 of the original 69 study participants reported 39 serious adverse events, for an overall exposure-adjusted rate of 0.12 serious adverse events per patient year. This rate did not increase with long-term exposure to etanercept.

Eight patients reported 9 medically important infections over the course of the long-term trial, for an overall exposure-adjusted rate of 0.03 medically important infections per patient year. This rate also did not increase with long-term exposure to etanercept.

The most common adverse event was a flare of JRA. There were no reported cases of tuberculosis, lupus; malignancies, lymphomas, nervous system disorders, or deaths.

Among patients who received 8 years of weekly etanercept treatment, 100% achieved an ACR Pedi 70 response, indicating 70% improvement in joint symptoms from baseline. Over the course of the study, only 7 patients withdrew from the study because of the therapy's lack of effectiveness on disease activity.

The authors noted that their study results demonstrated the long-term safety of etanercept comparable with studies of patients across a variety of rheumatic disorders.

SOURCE: Arthritis & Rheumatism

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