stormy

2/10/2004 (CHIPS)
CHIPS Network

REMICADE(R) Demonstrates Significant Results in the Treatment of Psoriasis
Patients With Psoriatic Arthritis
New ****ysis data presented at the American Academy of Dermatology Annual
Meeting shows huge potential for this new drug. The trial involved 249
patients, and showed a 91% improvment.


A new ****ysis was presented today at the annual meeting of the American
Academy of Dermatology (AAD) in Washington, DC from a Phase II study
investigating the effect of treatment with REMICADE(R) on quality of life in
249 patients with severe plaque psoriasis. In this study, treatment with
REMICADE resulted in significant improvement in quality of life from
baseline to week 10 versus placebo as measured by the Dermatology Life
Quality Index (DLQI). The median change from baseline was 84% for patients
treated with REMICADE 3 mg/kg and 91% for patients treated with REMICADE
5mg/kg. The median change from baseline in the placebo group was 0%.
"Psoriasis is a chronic disease that severely impacts quality of life,
affecting many aspects of a patient's life including work, family, ***ual
relations and physical and emotional well-being," said Steven R. Feldman,
M.D., Wake Forest School of Medicine. "Patients often live with the
condition, hoping for total clearance or relief of their symptoms and
continued research into potential treatments for psoriasis is critical for
patients with this difficult-to-treat disease."

REMICADE is a monoclonal antibody that specifically targets and irreversibly
binds to tumor necrosis factor-alpha (TNF-a) on the cell membrane and in the
blood. Overproduction of TNF-a is believed to play a role not only in
psoriasis, psoriatic arthritis, rheumatoid arthritis (RA) and Crohn's
disease, but also in a wide range of Immune-Mediated Inflammatory Disorders
(I.M.I.D.). REMICADE is currently indicated for the treatment of rheumatoid
arthritis and Crohn's disease and is being investigated in Phase III trials
for the treatment of severe psoriasis.

Study Findings

This study was a phase II, double blind, placebo-controlled trial to
investigate the safety and efficacy of REMICADE in 249 patients with
extensive or severe plaque psoriasis. Patients were randomly assigned to
infusions of 3 mg/kg or 5 mg/kg of REMICADE or placebo and were treated at
weeks zero, two and six. The primary endpoint of the study was the
percentage of patients achieving greater than or equal to 75% improvement in
the Psoriasis Area and Severity Index (PASI) score from baseline at week 10.
At week 10, significantly more patients treated with REMICADE achieved an
improvement of greater than or equal to 75% in their PASI score compared to
placebo-treated patients. The study also evaluated patient's health-related
quality of life through the use of the Dermatology Life Quality Index
(DLQI). The DLQI is a validated assessment of quality of life in adults with
dermatologic disease(1). DLQI responses are a series of questions scored in
increments of 0 to 3, with a maximum score of 30 indicating maximum
disability. Patients completed the Dermatology Life Quality Index (DLQI) at
baseline and week 10. The higher the DLQI score, the greater the impact on a
patient's quality of life.

The median percent change from baseline in DLQI at week 10 was a reduction
of 84 percent and 91 percent respectively for the 3 mg/kg and 5 mg/kg
REMICADE groups compared with 0 percent reduction in the placebo group
(p<0.001). Thirty-three and 40 percent of patients receiving REMICADE 3 or 5
mg/kg, respectively, had a DLQI score of 0 at week 10 (p<0.001). No patients
in the placebo group recorded a DLQI score of zero. A DLQI score of zero
indicates no reduction in quality of life.

During the ongoing clinical development program for REMICADE for this
investigational use, adverse reactions observed have generally been
consistent with those described in the prescribing information, including
information concerning serious infections (see Important Information).
Larger trials are necessary to establish a safety profile of infliximab in
the treatment of psoriasis.

About Psoriasis

According to the National Psoriasis Foundation, psoriasis is a chronic skin
disease that generally appears as patches of raised red skin covered by
flaky white scales. While the exact cause is unknown, psoriasis is believed
to be related to faulty inflammatory signals sent by the body's immune
system that causes development of skin plaques. Psoriasis affects more than
seven million Americans. This immune-mediated inflammatory disorder most
commonly appears between the ages of 15 and 35.

About REMICADE(R)

REMICADE is a monoclonal antibody that specifically targets and irreversibly
binds to tumor necrosis factor-alpha (TNF-a) on the cell membrane and in the
blood. Overproduction of TNF-a is believed to play a role in RA, Crohn's
disease (CD), a serious gastrointestinal disorder, and ankylosing
spondylitis (AS), in addition to a wide range of Immune-Mediated
Inflammatory Disorders (I.M.I.D.) in which REMICADE is currently being
studied.

REMICADE is the only anti-TNF biologic therapy that has received marketing
authorizations for the treatment of both RA and CD and, in the European
Union, AS. In most countries, REMICADE, in combination with methotrexate, is
indicated for the treatment of patients with moderately to severely active
rheumatoid arthritis who have had an inadequate response to methotrexate
alone. REMICADE is the only biologic indicated for the treatment of patients
with moderate to severe, 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 recto******l 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 received 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 conducted over the
past 10 years and through commercial experience with more than 400,000
patients treated worldwide -- more patients treated than all other TNF
inhibitors combined.

Important Information

Many people with heart failure should not take REMICADE; so, prior to
treatment, patients should discuss any heart condition with their doctor.
Patients should tell their doctor right away if they develop new or
worsening symptoms of heart failure (such as shortness of breath or swelling
of the ankles and feet).

There are reports of serious infections, including tuberculosis (TB) and
sepsis. Some of these infections have been fatal. Patients should tell their
doctor if they have had recent or past exposure to people with TB. Their
doctor will evaluate them for TB and perform a skin test.

If a patient has latent (inactive) TB, his or her doctor should begin TB
treatment before starting REMICADE. If a patient is prone to or has a
history of infections, currently has one, or develops one while taking
REMICADE, he or she should tell his or her doctor right away. Patients
should also tell their doctor if they have lived in a region where
histoplasmosis or coccidioidomycosis is common, or if they have or have had
a disease that affects the nervous system, or if they experience any
numbness, weakness, tingling, or visual disturbances.

There are also reports of serious infusion reactions with hives, difficulty
breathing, and low blood pressure. 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 the infusion such as rash or itchy skin. Please read
important information about REMICADE, including full prescribing
information, at http://www.remicade.com.

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 (I.M.I.D.), such as arthritis, 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. will market the product.

jxstern

....

Thanks for the post. Yep, Remicade is getting a great reputation for
effectiveness on psoriasis. Only problem is because it's not
biologically fully human, there are a fair number of people who have
allergic reactions to it which are dangerous enough on their own, and
of course mean those patients can't use the drug.

(No, I don't know the percentage, probably between 5% and 10%, I
gather)

Six office visits per year, sounds reasonable. Maybe they'll figure
out a way to do a home version.

J.

scottie

Enbrel also came out with results on P.
Amgens report noted the percentage of people achieving 75% on PASI.
A pity REMICADE's numbers were substituted by "significantly more"
compared to placebo.
It would be interesting to know if it did better or worse than enbrel.

patients

for

antibody

all

dick

How does one interpret "significant improvement?"

Enbrel has "improved" my skin quality, but not elimenated all signs.
Is that significant improvement?

gman13579

Ive had three doses and was 100% clear by dose three. I am in the study and go
in for my first dose in eight weeks the 24th. have one tiny dot on my right
forearm and that is the only sign of recurrence (sp?). I am confident the dose
in a week will knock out the little dot!!! In my opinion remicade is much more
effective. I have done enbrel, amevive, and raptiva. Remicade has acted the
quickest by far but i cant offer experience on how long it lasts. I anly did
raptiva for one 12 week course and it lasted a good 5 months. Amevive lost
effectiveness after the third course but i am crossing my fingers remicade
lasts longer. The study lasts over 18 months which is great i am in the
atlanta area and i believe they are still looking for guinea pigs, if anyone is
interested email me and i will give you the number. GOOD LUCK FELLOW FLAKERS!