Monday, October 20, 2003

DCRI Leads Pediatric Lupus Trial
By Mike Upchurch

Cholesterol-lowering statins have been shown definitively to lower cholesterol, and thus the risk of atherosclerosis, among adults. But now the DCRI aims to discover if these same drugs can help a patient population at particularly high risk - children with lupus.

Laura Schanberg, MD

Research shows that young girls with lupus have a heart attack risk as much as 50 times greater than girls the same age without the disease. Atherosclerosis, commonly called hardening of the arteries, is a prime factor in this increased risk and is much more common among young lupus patients. About 90% of pediatric lupus patients are female.

Lupus erythematosus is an autoimmune disease in which the body produces antibodies to its own tissues. The result is widespread inflammation that can cause arthritis, as well as damage to the kidneys and the protective tissue surrounding the heart.

The DCRI's Dr. Laura Schanberg will lead the APPLE (Atherosclerosis Prevention in Pediatric Lupus Erythematosus) trial, along with Stanford University's Dr. Christy Sandborg. The DCRI project leader for APPLE is Craig McClendon and Eric Yow is the lead statistician.

Beginning this fall, the trial will enroll 280 pediatric lupus patients at 20 sites around the country. All of the patients will receive their usual treatment for lupus, plus dietary counseling. They will also be randomized to either atorvastatin, a cholesterol reducer, or a placebo.

Cardiovascular trials have already proven that statins can reduce the risk of atherosclerosis, a fatty buildup of plaques in the arteries and a major contributing factor to heart disease. But no trials have tested the drugs in this particularly sensitive and vulnerable group of patients.

"We hope we will find that the patients treated with atorvastatin will exhibit a much lower rate of atherosclerosis, and therefore a lower risk for heart attack and stroke," said Schanberg.

This trial is the first large-scale pediatric rheumatology trial of its kind," she continued. "It is especially exciting because it is a collaboration among government, medical institutions, the pharmaceutical industry and the Childhood Arthritis and Rheumatology Research Alliance (CARRA)."

CARRA is a network of rheumatologists and clinical research sites based on the existing Pediatric Rheumatology Collaborative Study Group. Funded by The Arthritis Foundation and a number of other foundations, as well as several pharmaceutical makers, CARRA hopes to establish a nationwide infrastructure for large-scale pediatric rheumatology trials.

APPLE is being funded by a $10 million grant from National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health. Study drug will be provided by atorvastatin's manufacturer, Pfizer Inc.