New Phase III data show that treatment with REMICADE(R) (infliximab) resulted in significantly greater inhibition of
structural damage compared to placebo in patients with psoriatic arthritis. Radiographic analyses showed treatment with
REMICADE resulted in a mean change of -0.70 from baseline in structural damage as measured using the van der Heijde-Sharp
(vdH-S) scoring method. With this method, higher scores indicate greater structural damage while lower scores indicate less
structural damage. These 24-week data, presented this week at the European League Against Rheumatism (EULAR) Annual European
Congress of Rheumatology, also showed that REMICADE significantly reduced signs and symptoms of the joints and skin in these
patients.
"The inhibition of joint destruction is critical in the management and treatment of psoriatic arthritis patients," said
Desiree van der Heijde, MD, PhD, Professor of Rheumatology, University of Maastricht in the Netherlands and one of the
principal investigators in the trial. "While it is unclear exactly how to interpret negative score changes, the radiographic
evidence clearly shows that more patients experienced no worsening of joint destruction in the REMICADE group compared with
the placebo group."
In the Induction and Maintenance Psoriatic Arthritis Clinical Trial 2 (IMPACT 2), REMICADE-treated patients had significantly
less progression of structural damage compared to patients receiving placebo at week 24. Structural damage was measured
using the van der Heijde-Sharp score, an X-ray measure of changes in joint destruction, including joint erosion and joint
space narrowing. The mean (standard deviation) change from baseline in patients treated with REMICADE was a decrease of
-0.70 (2.53) score, compared to an increase of 0.82 ( 2.62) score in the placebo group (P < 0.001). Results were similar
when hands (P < 0.001), feet (P = 0.003), erosions (P < 0.001) and joint space narrowing (P = 0.013) were assessed.
Data presented from IMPACT 2 further demonstrated that treatment with REMICADE resulted in significant improvement in both
joint and skin disease. At week 14, 58 percent of REMICADE-treated patients achieved the primary efficacy outcome of at
least 20 percent improvement from baseline in arthritis symptoms as measured by the American College of Rheumatology scoring
criteria ACR 20, compared to 11 percent of patients receiving placebo (P < 0.001). Additionally, at week 14, 64 percent of
patients receiving REMICADE therapy experienced at least 75 percent improvement from baseline in the Psoriasis Area Severity
Index, compared to 2 percent of patients receiving placebo (P < 0.001). Similar results were seen at week 24.
REMICADE is a monoclonal antibody that specifically targets and binds to tumor necrosis factor-alpha (TNF-???) on the cell
membrane and in the blood. Overproduction of TNF-??? is believed to play a role in rheumatoid arthritis, ankylosing
spondylitis and psoriatic arthritis and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which
REMICADE is currently being studied.
Centocor, Inc. plans to submit a supplemental Biologics License Application (sBLA) with the United States Food and Drug
Administration (FDA) for inhibiting the progression of structural damage of active arthritis in patients with psoriatic
arthritis. REMICADE is approved in the U.S. and Europe for the treatment of active psoriatic arthritis. In May 2005,
REMICADE was approved in the U.S. for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis.
In September 2004, REMICADE received European Union approval, 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.
About IMPACT 2
IMPACT 2 was a Phase III randomized, double-blind, placebo-controlled study of 200 patients with active psoriatic arthritis
(defined as affecting at least five joints). The study evaluated the safety and efficacy of REMICADE in patients who had an
inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) or nonsteroidal anti-inflammatory drugs (NSAIDs).
Patients received REMICADE (5mg/kg) or placebo at weeks 0, 2, 6 and every 8 weeks until week 22. In patients with > 3
percent body surface area (BSA) psoriasis involvement at baseline, psoriasis activity was assessed using PASI at baseline and
weeks 2, 6, 14 and 24.
Through 24 weeks, a similar proportion of patients experienced adverse events (AEs) in each treatment group. No deaths,
cases of tuberculosis or other opportunistic infections or serious infusion reactions were reported and serious infections
were uncommon. Within 24 weeks of treatment, one placebo-treated patient was diagnosed with basal cell carcinoma. During
the continued treatment with REMICADE beyond week 24, one REMICADE patient was diagnosed with Hodgkin lymphoma. Laboratory
abnormalities were uncommon, with an elevation in liver function tests being the most common abnormality. There were more
patients with serious AEs in the REMICADE group (8.7 percent) than in the placebo group (6.2 percent). See "Important Safety
Information" below.
About Psoriatic Arthritis
Psoriatic arthritis 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 psoriatic
arthritis, and the disease affects both men and women equally, most commonly between the ages of 30 and 50. According to the
Arthritis Research Campaign, approximately 1 in 50 people have psoriasis in the United Kingdom and about 1 in 14 of these
individuals will develop psoriatic arthritis.
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 (EU) and
Japan. In the EU and in the U.S., REMICADE is approved for the treatment of active ankylosing spondylitis (AS) and psoriatic
arthritis.
In the EU, REMICADE is indicated for the treatment of severe, active CD in patients who have not responded despite a full and
adequate course of therapy with a corticosteroid and an
immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. REMICADE also is indicated
for the treatment of fistulizing, active CD in patients who have not responded despite a full and adequate course of therapy
with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
For RA patients in the EU, REMICADE, in combination with methotrexate, is indicated for the reduction of signs and symptoms
as well as the improvement in physical function in patients with active disease when the response to disease-modifying drugs,
including methotrexate, has been inadequate, and in patients with severe, active and progressive disease not previously
treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint
damage, as measured by X-ray, has been demonstrated.
In the EU, REMICADE is also indicated for treatment of AS in patients who have severe axial symptoms, elevated serological
markers of inflammatory activity and who have responded inadequately to conventional therapy.
In addition, REMICADE, in combination with methotrexate, is approved for the treatment of active and progressive psoriatic
arthritis in patients who have responded inadequately to disease-modifying anti-rheumatic drugs.
In the U.S., REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the
progression of structural damage, and improving physical function in patients with moderately-to-severely active RA.
REMICADE is the only biologic indicated for the treatment of patients with moderately-to-severely active CD 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 CD. In December 2004, REMICADE was
approved for the treatment of active AS and in May 2005, REMICADE was approved for reducing signs and symptoms of active
arthritis in patients with psoriatic arthritis in the U.S.
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, CD, and psoriatic arthritis, 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. In AS, REMICADE is a two-hour infusion (5 mg/kg) administered every six weeks,
following a standard induction regimen that requires treatment at weeks 0, 2 and 6. The safety and efficacy of REMICADE have
been well established in clinical trials over the past 12 years and through commercial experience with over a half a million
patients treated worldwide.
Important Safety Information
Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with
your doctor. Tell your doctor right away if you develop 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), sepsis and pneumonia. Some of these infections have
been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for
TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start
REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or
develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right
away.
Also tell your doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common.
There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Contact your doctor immediately if
you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe
fatigue.
Blood disorders have been reported, some fatal. Tell your 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 your doctor if you have or have had a disease that affects the nervous system, or if you experience 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 your doctor if you have or
have had 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. Please read important information about REMICADE, including full US
prescribing information, at remicade. For complete
REMICADE EU prescribing information, call Schering-Plough Corporation at +1 908-298-7616.
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 diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and
Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases. 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 discovered REMICADE and has exclusive marketing rights to the product in the United States. Schering-Plough
Corporation has rights to market REMICADE in all countries outside of the United States, except in Japan, China (including
Hong Kong), Taiwan and Indonesia, where Tanabe Seiyaku, Ltd. markets the product.
About Schering-Plough
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products.
Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets
advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians,
patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and
its Web site is schering-plough.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within
the meaning of the Securities Litigation Reform Act of 1995, including the company's strategy and the market for drugs to
treat rheumatoid arthritis. Forward-looking statements relate to expectations or forecasts of future events and use words
such as "will" and "plans." Actual results may vary materially from the forward-looking statements, and there are no
guarantees about the performance of Schering-Plough stock or Schering-Plough's business. Schering-Plough does not assume the
obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering-Plough's
forward-looking statements. These factors include uncertainties of the regulatory approval and review process and
difficulties in product development. For further details about these and other factors that may impact the forward-looking
statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's first quarter 2005 10-Q
and the 2004 annual report on Form 10-K.
Michael Parks
Centocor, Inc.
Denise Foy
Schering-Plough
View drug information on Remicade.
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