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Research is
underway to evaluate the potential of the first fully human monoclonal
antibody, D2E7 (adalimumab), in the treatment of juvenile rheumatoid
arthritis and Crohn's disease.
Monoclonal
antibodies mimic naturally occurring antibodies and can recognize
and neutralize proteins that are linked to promoting the inflammatory
process associated with many autoimmune diseases. Fully human
monoclonal antibodies have a protein structure that makes them
indistinguishable from antibodies found in the human body.
Juvenile rheumatoid
arthritis and Crohn's disease are autoimmune diseases in which
a human protein, tumor necrosis factor-alpha (TNF-alpha), has
been shown to cause abnormal immune responses. D2E7 works by specifically
targeting and blocking the activity of TNF-alpha.
"These
new trials are enrolling patients who may be facing joint destruction
at a young age with juvenile rheumatoid arthritis, or the serious
gastrointestinal symptoms associated with Crohn's disease,"
said Dr. Charles J. Fisher, Jr., divisional vice president, Global
Pharmaceutical Development at Abbott Laboratories.
The randomized,
multi-center, double-blind Phase III trial will study the safety
and effectiveness of D2E7 in patients with polyarticular juvenile
arthritis.
"We've
seen tremendous advances in the treatment of adult rheumatoid
arthritis and studies in pediatric patients are critical to understanding
the potential use of new treatments in children who are fighting
destructive symptoms at a much younger age," said Dr. Daniel
Lovell, chairman, Pediatric Rheumatology Study Group.
"This
disease can be particularly troubling for children because of
its impact on their ability to participate in activities with
other children. The symptoms of juvenile rheumatoid arthritis
are similar to adult rheumatoid arthritis, including swollen and
tender joints that if untreated may affect a child's growth and
development and lead to permanent joint destruction," Lovell
said.
D2E7 is currently
under review by the U.S. Food and Drug Administration for the
treatment of adult rheumatoid arthritis.
Other
sources: Abbott Laboratories
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