Enbrel® Shown
Safe, Effective in Children and Teenagers with Juvenile Rheumatoid
Arthritis
Enbrel®
(etanercept) has been shown to be a safe and effective drug in the
treatment of children and teenagers with polyarticular juvenile
rheumatoid arthritis (JRA), according to clinical trial results
reported in the New England Journal of Medicine.
In this clinical trial, 69 children, ages
4 to 17, were injected with Enbrel® twice a week; 74
percent responded with measurable improvement when treated for three
months. At the end of three months of treatment, on average, there was
a 56 percent decrease in the number of joints with active arthritis, a
75 percent decrease in the amount of joint stiffness and a 63 percent
decrease in the amount of joint pain. All measures of arthritis impact
— symptoms, joint abnormalities, ability to perform daily functions
and laboratory tests — were dramatically improved. The drug was well
tolerated.
The trial was coordinated at the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Multipurpose Arthritis and Musculoskeletal Diseases Center at the
Children's Hospital Medical Center of Cincinnati, Ohio. It was
performed by investigators in the Pediatric Rheumatology Collaborative
Study Group. Its success is the culmination of many years of basic
research supported by the NIAMS and other NIH components.
"These findings show a significant —
often profound — improvement for most children with JRA when treated
with Enbrel® compared to placebo," said Daniel J. Lovell,
M.D., M.P.H., principal investigator and lead author. "Before Enbrel®,
many children with severe JRA had a poor response to existing
treatment options. Often, they would have to stop attending school.
Now, there is hope for these children."
NIAMS Director Stephen I. Katz, M.D.,
Ph.D., stated, "Juvenile rheumatoid arthritis can be a devastating
disease, not only to the children who have it, but to their families
as well. We are pleased to have supported the basic research behind
this drug that relieves so much pain and reduces the amount of joint
destruction."
Enbrel® belongs to a new class
of drug treatments called "biologic agents" that are designed to
interfere with the specific biological process of a disease. Enbrel®
is a tumor necrosis factor (TNF) antagonist, a substance that blocks
the action of TNF, a naturally occurring protein in the body that
helps cause inflammation. It acts as a "sponge" to absorb TNF.
The clinical trial adhered to the Food
and Drug Administration's "Pediatric Rule," which requires
manufacturers of new drugs and biologic agents that will be commonly
used for children to provide specific information about safe pediatric
use.
JRA is a type of arthritis that causes
joint inflammation and stiffness for more than six weeks, beginning
when the child is 16 years of age or less. Inflammation causes
redness, swelling, warmth and soreness in the joints, although many
children with JRA do not complain of joint pain. Any joint can be
affected and inflammation may limit the mobility of affected joints.
There are three types of JRA: polyarticular (affecting five or more
joints), pauciarticular (affecting four or fewer joints) and systemic,
also called Still's disease (joint swelling, fever, rash, and organ
involvement).
NIAMS web site at
http://www.nih.gov/niams.
Enbrel® (etanercept) is
a trademark of Immunex Corporation, which markets Enbrel®
in North America with Wyeth-Ayerst, a division of American Home
Products Corporation. Manufactured by Immunex, Seattle, Wash.
Reference
Lovell D, Giannini, E, Reiff A, Cawkwell G, Silverman E, Nocton J,
Stein L, Gedalia A, Ilowite N, Wallace C, Whitmore J, Finck B.
Etanercept in children with polyarticular juvenile rheumatoid
arthritis. NEJM 2000;342:763-9.
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