FDA Accepts Application Requesting Approval of REMICADE in the Treatment of
Psoriatic Arthritis
MALVERN, Pa.--(BUSINESS WIRE)---- Supporting Data Show Significant Reduction
of Joint and Skin Symptoms in Psoriatic Arthritis
Centocor, Inc. announced today that the U.S. Food and Drug Administration
(FDA) has accepted its filing of a supplemental Biologics Licensee Application
(sBLA) for REMICADE(R) (infliximab) for the treatment of psoriatic arthritis
(PsA) in patients with active disease. PsA is a chronic, potentially
debilitating
disease, which affects approximately one million people and causes joint
inflammation frequently associated with active psoriasis.
"We are pleased that the FDA has accepted this application for REMICADE in
the treatment of psoriatic arthritis," said Cynthia Guzzo, Senior Director,
Clinical Research, Centocor, Inc. "The results we have seen are extremely
encouraging and we hope to gain approval for patients impacted by this disease."
The filing is based on the results of two double-blind, placebo-controlled
trials, IMPACT and IMPACT 2. The study results were presented in October 2004 at
the American College of Rheumatology Annual Scientific Meeting and in June
2004 at the European League Against Rheumatism's Annual European Congress of
Rheumatology.
IMPACT 2 is a Phase III, multi-center, randomized, double-blind,
placebo-controlled trial that demonstrated that treatment with REMICADE 5 mg/kg
resulted
in marked improvements in patients with PsA and significant improvement in both
joint and skin disease was evident as early as week 2. These data showed that
at week 14, more than half of the patients in the REMICADE treatment group
achieved significant improvements in the signs and symptoms of PsA as measured
by the proportion of patients achieving ACR 20 (58 percent of the REMICADE
patient group versus 11 percent placebo, p less than 0.001) and 75 percent
improvement in PASI (63.9 percent of the REMICADE treatment group versus 2.3
percent
placebo, p less than 0.001). The ACR 20 and PASI 75 responses were achieved
regardless of concomitant methotrexate use or level of joint involvement at
baseline.
Furthermore, compared to placebo, significantly more subjects in the REMICADE
treatment group achieved ACR 70 or PASI 90 as early as week 6 and improved or
maintained these results at later points in the study. At week 24, results
showed that 27 percent of patients treated with REMICADE exhibited a 70 percent
improvement in symptoms of arthritis (as measured by ACR 70) compared with 2
percent in the placebo group (p less than 0.001).
Thirty-nine percent of patients showed a 90 percent improvement in psoriasis
(as measured by PASI 90) compared with 0 percent in the placebo group (p less
than 0.001). In the first study, IMPACT, 104 people were randomized to
REMICADE (5mg/kg) or placebo. At week 16, 65 percent (n=34) of people on
REMICADE
therapy achieved ACR 20. Additionally, of the 38 people with evaluable
psoriasis,
68 percent (n=15) achieved a 75 percent or greater improvement from baseline
(PASI 75) indicating clinically meaningful improvement in psoriasis.
Significant improvements were maintained through 1 year.
REMICADE was generally well tolerated in these studies, with similar numbers
of patients experiencing adverse events (AE) in each group. No deaths, cases
of tuberculosis or other opportunistic infections were reported and serious
infections and infusion reactions were uncommon. Also, with the exception of one
case of basal cell carcinoma in the placebo group, no malignancies were
reported. In general, the AE observed in these studies were consistent with
those
reported in other indications, and most common AE included events that commonly
occur in the general population. Significant laboratory abnormalities were
unusual, with an elevation in liver function tests during the IMPACT 2 trial
being the most common abnormality. Overall, there were slightly more patients
with
serious AE in the REMICADE group than in placebo. See "Important Information"
below.
About Psoriatic Arthritis
PsA involves joint pain and swelling that can lead to debilitation coupled
with inflamed, scaly, red patches of psoriasis. Symptoms may include stiffness
and tenderness of the joints and surrounding tissue, reduced range of motion,
nail changes and redness and pain of the eye. Joints of the hands, wrists,
knees, ankles, feet, lower back and neck are commonly affected. Approximately
one
million Americans have PsA, and the disease affects both men and women
equally, most commonly between the ages 30 and 50.
About REMICADE
REMICADE is the global market leader among anti-tumor necrosis factor alpha
(TNF-alpha) therapies and the only agent approved for the treatment of both
rheumatoid arthritis (RA) and Crohn's disease (CD) in North America, the
European
Union and Japan, and was the first biologic approved for ankylosing
spondylitis in the European Union. In the EU, REMICADE is indicated for the
treatment
of ankylosing spondylitis in patients who have severe axial symptoms, elevated
serological markers of inflammatory activity and who have responded
inadequately to conventional therapy.
In September, the European Commission gave approval for expanded labeling for
REMICADE, in combination with methotrexate, for the treatment of active and
progressive psoriatic arthritis in patients who have responded inadequately to
disease modifying anti-rheumatic drugs.
REMICADE is the only biologic indicated for the treatment of patients with
moderately-to-severely active Crohn's disease who have had an inadequate
response to conventional therapy. REMICADE is also indicated for reducing the
number
of draining enterocutaneous and rectovaginal fistulas and maintaining fistula
closure in patients with fistulizing Crohn's disease.
REMICADE is unique among available anti-TNF biologic therapies. Unlike
self-administered therapies that require patients to inject themselves
frequently,
REMICADE is the only anti-TNF biologic administered directly by caregivers in
the clinic or office setting. In RA and CD patients, REMICADE is a two-hour
infusion administered every eight weeks, following a standard induction regimen
that requires treatment at weeks 0, 2 and 6.
As a result, REMICADE patients may require as few as six treatments each
year. The safety and efficacy of REMICADE have been well established in clinical
trials over the past 12 years and through commercial experience with more than
a half million patients treated worldwide.
Important Information
Many people with heart failure should not take REMICADE; so prior to
treatment discussion of any heart condition with a doctor is necessary. A doctor
should be informed right away of new or worsening symptoms of heart failure
(such
as shortness of breath or swelling of your ankles or feet).
There are reports of serious infections, including tuberculosis (TB) and
sepsis. Some of these infections have been fatal. Tell your doctor if you have
had
recent or past exposure to people with TB.
Evaluation for TB should be performed. If latent (inactive) TB exists, a
doctor should begin TB treatment before starting REMICADE. REMICADE can lower
one's ability to fight infections, so if prone to or if a history of
infection(s)
exists, or one develops any signs of an infection such as fever, fatigue,
cough, or the flu while taking REMICADE, tell a doctor right away. Also tell a
doctor if you have lived in a region where histoplasmosis or coccidioidomycosis
is common. Blood disorders have been reported, some fatal. Tell a doctor if you
develop possible signs of blood disorders such as persistent fever, bruising,
bleeding, or paleness while taking REMICADE. Nervous system disorders have
also been reported.
Tell a doctor if there is a history of a disease(s) that affects the nervous
system, or if one experiences any numbness, weakness, tingling, or visual
disturbances while taking REMICADE. Reports of lymphoma (a type of cancer) in
patients on REMICADE and other TNF blockers are rare but occur more often than
in
the general population; tell a doctor if there exists a history of cancer.
Serious infusion reactions have been reported with REMICADE, including hives,
difficulty breathing, and low blood pressure. Reactions have occurred during
or after infusions. In clinical studies, some people experienced the following
common side effects: respiratory infections (that may include sinus
infections and sore throat), coughing, and stomach pain or mild reactions to
infusion
such as rash or itchy skin.
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. The company is dedicated to the research and
development of treatments for a wide range of Immune-Mediated Inflammatory
Disorders
(IMID), such as arthritis and inflammatory skin diseases and for cancer.
Centocor's 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.
Centocor has exclusive marketing rights to REMICADE in the United States.
Schering-Plough Corporation (NYSE:SGP) has rights to market REMICADE in all
other
countries throughout the world, except in Japan and parts of the Far East
where Tanabe Seiyaku, Ltd. markets the product.
Centocor, Inc. Michael Parks, 215-325-4010 Mobile: 610-216-3965
12/1/2004 09:01 ET
© Business Wire 2003