FDA Approves REMICADE(R) With Methotrexate as First Drug To Inhibit Progression of Joint Damage in
Rheumatoid Arthritis
REMICADE(R) Also Controls Pain and Stiffness of This Disease
MALVERN, Pa., Jan. 2 /PRNewswire/ -- Millions of rheumatoid arthritis
sufferers have good news today. For the first time, the U.S. Food and Drug
Administration (FDA) has approved a drug to inhibit the progression of joint
damage in patients with rheumatoid arthritis, a chronic and debilitating
disease that affects 2.1 million Americans, mostly women.
The FDA granted marketing approval to REMICADE(R) (infliximab), in
combination with methotrexate, for inhibiting the progression of structural
damage in patients with moderately to severely active rheumatoid arthritis who
have had an inadequate response to methotrexate.
"For the first time, we now have a drug that can inhibit the progression
of joint damage as well as control the pain and stiffness associated with this
disease," said Michael Spiegel, M.D., ATTRACT trial investigator, Danbury, CT.
"This is excellent news for patients. REMICADE can have a tremendous impact
on patients."
REMICADE with methotrexate was first approved for marketing in October
1999 for the treatment of signs and symptoms of rheumatoid arthritis in
patients who have had an inadequate response to methotrexate.
REMICADE Inhibits Joint Damage on Two Fronts
In patients with rheumatoid arthritis, joint damage is evident as
narrowing of the joint space between bones and erosion of the bones at the
joint space. REMICADE inhibits both of these conditions.
"Joint damage progression in rheumatoid arthritis has two key components,
joint space narrowing and joint erosion. Clinical data demonstrates that
REMICADE inhibits not only joint erosions but joint space narrowing as well.
This provides considerable benefit to patients while also improving the pain
and stiffness associated with the disease," said Thomas Schaible, PhD, senior
director, medical affairs, Centocor.
Basis for Approval
Approval was based on 54-week data from the two-year ATTRACT trial
(Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy), one of the
largest and longest controlled rheumatoid arthritis clinical trials involving
428 patients at 34 centers in North America and Europe.
In the double blind, placebo-controlled, randomized clinical study,
patients treated with REMICADE in combination with methotrexate were compared
to those patients treated with methotrexate plus a placebo. Methotrexate is a
standard treatment for many patients with rheumatoid arthritis.
In the ATTRACT trial, progression of joint damage was measured
radiographically using the van der Heijde modified Sharp system, which
evaluates changes in joint-space narrowing and bone erosion on a 5-point scale
(a higher score indicates more damage). Among all REMICADE treatment groups,
overall median change from baseline for radiographic scores of 0.0 were
reported among patients treated with the combination of REMICADE plus
methotrexate (n=285) compared to a median change of 4.0 for patients treated
with methotrexate alone (n=63). A total of 53 percent of REMICADE patients
demonstrated 0 percent progression .
The methotrexate-only findings (control arm) demonstrated progression
comparable to that previously reported for patients with established
rheumatoid arthritis treated with methotrexate.
Patients on REMICADE plus methotrexate also reported significantly greater
relief from the pain and stiffness of the disease as well as a reduction in
the number of swollen and tender joints. After 54 weeks of therapy, more than
half (52 percent) of those treated with REMICADE and methotrexate experienced
a reduction in the signs and symptoms of RA as measured by ACR 20, a standard
assessment for disease activity, compared to 17 percent of patients receiving
methotrexate alone.
"The prospect of having a therapy that can actually inhibit the damage
caused by rheumatoid arthritis is extremely exciting," said Virginia Ladd,
president and executive director of the American Autoimmune Related Diseases
Association (AARDA). "Rheumatoid arthritis patients and their doctors will
now have a new tool at their disposal for managing this terrible disease."
REMICADE Generally Well Tolerated
In the clinical trials, REMICADE was generally well tolerated. The most
common adverse events included upper respiratory infection, headache, mild
reactions to the infusion, sinusitis, rash and cough. There was no increased
incidence of serious adverse events or serious infections in patients
receiving REMICADE and methotrexate compared to those receiving placebo and
methotrexate. The incidence of infusion reactions was also low in REMICADE
plus methotrexate patients (approximately three percent) for any given
infusion compared to those receiving methotrexate alone (approximately two
percent).
TNF-alpha mediates inflammation and cellular immune response including
response to infection. Serious infections, including sepsis and disseminated
tuberculosis, have been reported in patients receiving TNF-blocking agents,
including REMICADE. Some of these infections have been fatal. Many of the
serious infections in patients treated with REMICADE have occurred in patients
on concomitant immunosuppressive therapy that, in addition to their Crohn's
disease or rheumatoid arthritis, could predispose them to infections.
Caution should be exercised when considering the use of REMICADE in
patients with a chronic infection or a history of recurrent infection.
REMICADE should not be given to patients with a clinically important, active
infection. Patients should be monitored for signs and symptoms of infection
while on or after treatment with REMICADE. New infections should be closely
monitored. If a patient develops a serious infection including sepsis,
REMICADE therapy should be discontinued. Patients should be evaluated for the
risk of tuberculosis, including latent tuberculosis. Treatment for
tuberculosis should be initiated prior to treatment with REMICADE.
REMICADE and other agents that inhibit TNF have been associated in rare
cases with exacerbation of clinical symptoms and/or radiographic evidence of
de-myelinating disease. Prescribers should exercise caution in considering
the use of REMICADE in patients with pre-existing or recent onset of central
nervous system de-myelinating disorders.
Please see remicade.com for full prescribing information for
treatment of signs and symptoms of rheumatoid arthritis and additional
information regarding warnings, precautions and adverse events.
About REMICADE
REMICADE was initially cleared for marketing in the US in 1998, for short
term use in patients with Crohn's disease, a serious gastrointestinal
disorder. Centocor currently markets REMICADE in the United States.
Schering-Plough Corporation (NYSE: SGP) has rights to REMICADE in all other
countries throughout the world, except in Japan and parts of the Far East
where REMICADE will be marketed by Tanabe Seiyaku, Ltd.
About Centocor
Centocor is a leading biopharmaceutical company that creates, acquires and
markets cost-effective therapies that yield long-term benefits for patients
and the healthcare community. Its products, developed primarily through
monoclonal antibody technology, help physicians deliver innovative treatments
to improve human health and restore patients' quality of life. Centocor is a
wholly owned subsidiary of Johnson & Johnson, the worldwide manufacturer of
healthcare products. For additional information about Centocor and its
products, visit Centocor's Web sites: centocor.com or
remicade.com.
Contact: Christopher Allman, 610-651-6546, or beeper, 888-814-8342, for
Centocor.
SOURCE Centocor
Web Site: centocor.com remicade.com |
