Enbrel safety data for up to 8 years in patients with juvenile rheumatoid arthritis

Jun 17 2007

Amgen and Wyeth Pharmaceuticals, a division of Wyeth have announced the presentation of additional data that showed that the safety profile of Enbrel, (etanercept) was maintained with long-term use in patients with moderate-to-severe juvenile rheumatoid arthritis (JRA) who completed up to eight years of therapy.

JRA is a chronic autoimmune disease of childhood that is sometimes difficult to diagnose. ENBREL is the only biologic medicine currently approved to treat the signs and symptoms of JRA in patients who have previously tried a traditional disease modifying antirheumatic drug (DMARD). The study results will be presented at the European League Against Rheumatism (EULAR) Annual Congress, an international rheumatology meeting, in Barcelona, Spain.

Approximately 50,000 children in the United States have JRA. Symptoms of JRA include fatigue, joint pain and stiffness following sleep or inactivity, fever and associated muscle weakness. There are differing presentations of the signs and symptoms of JRA and there is no specific test for diagnosis.

"Early diagnosis and treatment are crucial to managing symptoms of JRA," says Andreas O. Reiff, M.D., head of Rheumatology and Rehabilitation at Children's Hospital Los Angeles and study investigator, who will be presenting the data at EULAR. "The ENBREL data are important for both physicians and parents because they demonstrate the safety profile has remained consistent after long-term use in this patient population."

The study, which was designed to assess the long-term safety of ENBREL in people with JRA, found that the overall rate of serious adverse events did not increase with long-term use of ENBREL. No deaths, lymphomas or other malignancies, tuberculosis or other opportunistic infections were reported. Sixty-one percent of patients studied (n=42) entered their fourth year of continuous ENBREL treatment. Further, 38 percent (n=26) of patients studied entered their eighth year of continuous ENBREL treatment and experienced a similar safety profile.

Patients with JRA who participated previously in a double-blind, randomized controlled trial of ENBREL (n=69) were eligible to enroll in this multicenter open-label extension study (n=58). Safety assessments included the incidence of serious adverse events, deaths, lymphomas, malignancies, opportunistic infections and medically important infections.