Study affirms effectiveness of medication for juvenile rheumatoid arthritis

58 JRA patients, 84 percent of the participants in the randomized 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 percent) and white (74 percent), and all had taken MTX 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. 42 of these patients (72 percent) entered the fourth year of continuous etanercept treatment, and 26 patients (45 percent) entered the eighth year. Here’s an overview of the results:

• 16 of the original 69 study participants reported 39 serious adverse events, for an overall exposure-adjusted rate of 0.12 SAEs per patient year. This rate did not increase with long-term exposure to etanercept.
  
  
• 8 patients reported 9 medically important infections over the course of the long-term trial, for an overall exposure-adjusted rate of 0.03 MIIs per patient year. This rate 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, which has been linked to anti-TNF therapy, or lupus; no malignancies or lymphomas; no nervous system disorders; and no deaths.
  
  
• Among patients who received 8 years worth of weekly etanercept treatment, 100 percent achieved an ACR Pedi 70 response, indicating 70 percent improvement in joint symptoms from baseline. Over the course of the study, only 7 patients withdrew due to the therapy’s lack of effectiveness on disease activity.
  
  

“Continuous treatment with etanercept resulted in truly important, often profound, sustained improvement in all aspects of this disease including clinically important signs and symptoms of JRA, improvements in functional ability and decreased pain for up to 8 years,” notes study group spokesperson Dr. Daniel J. Lovell. Demonstrating long-term safety comparable to studies of patients across a variety of rheumatic disorders, this study supports the potential of etanercept therapy to give children with JRA the promise of a better quality of life as adults.

Article: “Safety and Efficacy of up to Eight Years of Continuous Etanercept Therapy in Patients with Juvenile Rheumatoid Arthritis,” Daniel J. Lovell, Andreas Reiff, Norman T. Ilowite, Carol A. Wallace, Yun Chon, Shao-Lee Lin, Scott W. Baumgartner, and Edward H. Giannini, for the Pediatric Rheumatology Collaborative Study Group, Arthritis & Rheumatism, May 2008; 58:5 pp. 1496-1504.