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Biologic Therapy, Abatacept, Shows Promise in the Treatment of Children with Severe, Treatment Resistant Juvenile Idiopathic Arthritis

ATLANTA, GA -- November 14, 2007 -- Abatacept, a biologic therapy used to treat adults with moderate to severe rheumatoid arthritis, may be a well-tolerated treatment for juvenile arthritis, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Boston, Mass.

Juvenile idiopathic arthritis, also known as juvenile rheumatoid arthritis, is the most common form of arthritis in children. There are several different types of JIA. All cause joint inflammation and begin before the age of 16, but otherwise are often associated with distinct symptoms and complications and may require different approaches to treatment.

Abatacept (Orencia) selectively inhibits T-cell activation, which is important in causing JIA symptoms. Trials in adults with rheumatoid arthritis have shown that abatacept induces significant improvement in disease and health-related quality of life, and inhibits progression of structural damage in patients who did not respond to other disease-modifying antirheumatic drugs including anti-TNF therapies.

Researchers recently evaluated the effectiveness and safety of abatacept in children and adolescents with active, treatment-resistant polyarticular JIA (with a focus on the safety of the treatment) in a phase III, double-blind, randomized, placebo controlled withdrawal trial.

This is the first trial to allow patients who had failed prior anti-TNF therapy biologic therapy to enroll, At the end of four months of open label treatment, 123 (65%) of the 190 patients enrolled were considered "responders," as they met the ACR Pediatric 30 (a validated, standardized definition of response). In those who had previously failed prior anti-TNF therapy, 39% met the ACR Pediatric 30.

Responders entered the blinded phase of the study and were randomized to either continue abatacept or receive placebo for up to 6 months, or until they met standardized definition for disease flare. Patients randomized to the placebo group compared to the abatacept group demonstrated disease flare much more frequently (53% vs. 20%, respectively) and quickly. An ACR Pediatric 90 response (representing excellent disease control) was seen in 40% of those who received abatacept for the 10 months of the study.

During the open-label lead-in, six patients reported serious adverse events, of which three were related to underlying disease. In the double-blind period, no SAEs were reported in the abatacept group and three SAEs were reported in two patients in the placebo group.

The overall frequencies of all adverse events were similar in the two treatment groups. Infusion reactions were reported in 1.7% versus 3.2% of the abatacept and placebo groups, respectively; all were mild/moderate (none serious) in intensity. No serious infections, autoimmune disorders or anaphylaxis episodes were reported in any period. No consistent patterns of abnormal liver/kidney function tests or hematological parameters emerged.

"The results of this randomized double blind trial of abatacept were very encouraging for both efficacy and safety in these children with severe polyarticular JIA. Abatacept was effective for many of the children who had already failed anti-TNF therapy. Because of its unique mechanism of action, abatacept is an important new treatment approach for children with JIA," said Daniel J. Lovell, MD, MPH, professor of pediatrics at Cincinnati Childrens Hospital Medical Center and a lead investigator in the study. The participating clinical investigators in this international collaborative effort were from the Pediatric Rheumatology Collaborative Study Group and the Pediatric Rheumatology International Trials Organization.


SOURCE: American College of Rheumatology

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