According to data presented today
at the American College of Rheumatology (ACR) Annual Scientific Meeting,
women and men (average age of 45 years) with rheumatoid arthritis (RA) who
have sustained, moderate disability have similar reductions in the
probability of employment and full-time employment. From the analysis,
investigators concluded that physical function and disease duration are
important factors associated with lack of employment in RA and that
improving physical function and treating patients earlier may have a
substantial impact on work disability. RA is the most common form of
inflammatory arthritis, affecting more than two million Americans, and
about 75 percent of those affected are women.(1)
"The ATTRACT and ASPIRE trials showed that intervention with REMICADE
(infliximab), in combination with methotrexate, reduced the signs and
symptoms, inhibited joint damage, and improved physical function in
patients with moderately to severely active RA," said Josef Smolen, MD,
Professor of Internal Medicine and Chairman of the Department of
Rheumatology of Vienna General Hospital, and investigator in both studies.
"Importantly, these latest analyses, based on patient characteristics at
enrollment in these trials, offer further insight on how the burden of this
disease relates to the probability of employment for women and men living
with RA."
According to a multiple regression analysis of data from the ATTRACT
and ASPIRE studies, which evaluated more than 1,400 patients with active
RA, employment was statistically significantly associated with physical
function, age, gender or disease duration at baseline. A regression model
showed that for a 45-year-old woman with RA with sustained moderate
disability (defined as a Health Assessment Questionnaire score of 1.5), the
probability of employment decreased from 0.63 to 0.56 to 0.48 to 0.40 after
five, 10 and 15 years of disease onset, respectively. For full-time
employment, the probability decreased from 0.48 to 0.38 to 0.28 to 0.20 at
five-year intervals over the course of 15 years.
For a man of the same age, disability level and disease duration, the
probability of being employed decreased from 0.69 to 0.62 to 0.54 to 0.46
after five, 10 and 15 years of disease onset, respectively. The model also
showed that the probability of full-time employment for a man decreased
from 0.64 to 0.55 to 0.43 to 0.33 at five-year intervals over the course of
15 years. The difference in employability between women and men after 15
years was similar to baseline differences seen between the genders. HAQ
scores of 0 to 1 are generally considered to represent mild to moderate
difficulty, 1 to 2 moderate to severe disability and 2 to 3 severe to very
severe disability. Average scores that have been reported in a
population-based study are 0.49, and in RA patients are 1.2.(2)
About ATTRACT
The Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy
(ATTRACT) study included 428 patients at 34 research centers in North
America and Europe. All patients had moderately to severely active RA
despite taking methotrexate. To enter the study, patients had to have at
least six swollen joints (out of 66) and six tender joints (out of 68).
Also, patients had X- rays of their hands and feet to look for evidence of
joint damage. Blood samples were taken to look for rheumatoid factor or for
high levels of C- reactive protein, which is a sign of inflammation. Many
patients were taking other medications such as nonsteroidal
anti-inflammatory drugs (NSAIDs) or steroids. Patients were randomized to
receive REMICADE 3 mg/kg or 10 mg/kg plus methotrexate or placebo plus
methotrexate at weeks 0, 2 and 6 and then every eight weeks thereafter
through week 102.
During the ATTRACT study, the incidence of side effects was similar for
patients treated with REMICADE and methotrexate and with placebo and
methotrexate. The most frequently reported side effects were upper
respiratory tract infection, headache, nausea, sinusitis and rash. The
incidence of serious side effects was low and was similar in patients
treated with REMICADE and methotrexate and with placebo and methotrexate.
The most frequent serious adverse event that occurred in patients treated
with REMICADE and methotrexate was pneumonia. Please see "Important Safety
Information" below.
About ASPIRE
The Active-Controlled Study of Patients Receiving Infliximab for
Treatment of Rheumatoid Arthritis of Early Onset (ASPIRE), the largest
controlled trial ever conducted exclusively in RA patients with early
disease, found REMICADE plus methotrexate to be superior to placebo and
methotrexate in patients with moderately to severely active disease. ASPIRE
was a 54-week, randomized, double blind, active control study involving
1,004 patients with early disease enrolled in 125 centers in North America
and Europe. At randomization, all patients received methotrexate and either
placebo, REMICADE 3 mg/kg or REMICADE 6 mg/kg at weeks 0, 2 and 6 and then
every eight weeks thereafter. The ASPIRE trial demonstrated superiority of
the REMICADE and methotrexate regimen over placebo and methotrexate on all
three primary endpoints, including reduction of signs and symptoms,
inhibition of the progression of structural damage and improvement in
physical function.
During the ASPIRE study, the most commonly reported adverse events were
upper respiratory infection, nausea and headache. Serious infections
included pneumonia, tuberculosis and sepsis. Please see "Important Safety
Information" below.
About Rheumatoid Arthritis
RA is a chronic, progressive disease and research suggests that a
critical therapeutic window may exist within the first two years of disease
onset when the rate of radiographic progression of the disease can be
"reset."(3, 4, 5) Radiographic changes occur within two years of disease
onset in 50-70 percent of RA patients.(6) The American College of
Rheumatology (ACR) suggests control of disease progression should start
early to limit joint damage in RA.(5) RA is associated with substantial
disability and economic losses, and one study showed that one-third of
patients in the UK who were employed became work-disabled within two years
of disease onset.(7) Rheumatologic disorders also account for 25 percent of
Social Security disability payments.(8)
About REMICADE
REMICADE is a monoclonal antibody that specifically targets TNF-alpha,
which has been shown to play a role in Crohn's disease (CD), rheumatoid
arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA),
ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis
(PsO). 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 RA and CD in North America, the European Union (EU) and
Japan. Additionally, REMICADE is the only anti-TNF approved in three
different therapeutic areas: gastroenterology, rheumatology and
dermatology. The safety and efficacy of REMICADE have been well established
in clinical trials over the past 14 years and through commercial experience with more than 840,000 patients treated worldwide.
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 reducing
signs and symptoms and inducing and maintaining clinical remission in adult
and pediatric 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 reducing signs and symptoms in
patients with active AS. In May 2005, REMICADE was approved for reducing
signs and symptoms of active arthritis in patients with PsA. Additionally,
in September 2005, REMICADE was approved for reducing signs and symptoms,
achieving clinical remission and mucosal healing, and eliminating
corticosteroid use in patients with moderately to severely active UC who
have had an inadequate response to conventional therapy. This approval
makes REMICADE the first and only biologic approved for the treatment of
moderate to severe UC. In May 2006, REMICADE was approved for reducing
signs and symptoms and inducing and maintaining clinical remission in
pediatric patients with moderately to severely active Crohn's disease who
have had an inadequate response to conventional therapy. This approval
establishes REMICADE as the first and only biologic therapy approved for
the treatment of PCD. In August 2006, REMICADE was approved for inhibiting
progression of structural damage and improving physical function in
patients with psoriatic arthritis. In September 2006, REMICADE was approved
for the treatment of adults with chronic, severe (i.e. extensive and/or
disabling) plaque psoriasis who are candidates for systemic therapy and
when other systemic therapies are medically less appropriate. In October
2006, REMICADE was approved for maintaining clinical remission and mucosal
healing in patients with moderately to severely active UC, who have had an
inadequate response to conventional therapy.
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/or 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 carefully selected patients
with RA who have tolerated three initial two-hour infusions of REMICADE,
consideration may be given to administering subsequent infusions over a
period of not less than one hour.
In the EU, REMICADE is also indicated for the treatment of AS in
patients who have severe axial symptoms, elevated serological markers of
inflammatory activity and who have responded inadequately to conventional
therapy. REMICADE is also approved for the treatment of active and
progressive PsA in patients who have responded inadequately to disease
modifying anti-rheumatic drug therapy. REMICADE should be administered in
combination with methotrexate or alone in patients who show intolerance to
methotrexate or for whom methotrexate is contraindicated. REMICADE is also
approved in the EU for the treatment of moderate to severe plaque psoriasis
in adults who failed to respond to, or have a contraindication to, or are
intolerant of other systemic therapy including cyclosporine, methotrexate
or PUVA (psoralen plus ultraviolet A light).
In February 2006, REMICADE was approved in the EU for the treatment of
moderately-to-severely active UC in patients who have had an inadequate
response to conventional therapy, including corticosteroids and 6-MP or
azathioprine, or who are intolerant to or have medical contraindications
for such therapies. This approval made REMICADE the first and only biologic
therapy approved to treat moderate-to-severe UC in the EU.
REMICADE is the only anti-TNF biologic therapy available as an IV form.
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 (3 mg/kg), CD
(5 mg/kg), PsA (5 mg/kg), UC (5 mg/kg), PCD (5 mg/kg), and PsO (5 mg/kg),
REMICADE is a two-hour infusion administered every 8 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 (5 mg/kg), REMICADE is a two-hour infusion administered every 6
weeks, following a standard induction regimen that requires treatment at
weeks 0, 2 and 6.
Centocor discovered REMICADE and has exclusive marketing rights to the
product in the United States.
Schering-Plough markets REMICADE in all countries outside of the United
States, except in Japan and parts of the Far East where Tanabe Seiyaku,
Ltd. markets the product and in China where Xian-Janssen markets REMICADE.
Important Safety Information
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 TB 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, flu or warm, red or painful skin
while taking REMICADE, tell your doctor right away. Also, tell your doctor
if you are scheduled to receive a vaccine or if you have lived in a region
where histoplasmosis or coccidioidomycosis is common.
Reports of a type of blood cancer called lymphoma in patients on
REMICADE or other TNF blockers are rare but occur more often than expected
for people in general. People who have been treated for rheumatoid
arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, or
plaque psoriasis for a long time, particularly those with highly active
disease may be more prone to develop lymphoma. Cancers, other than
lymphoma, have also been reported. Children and young adults who have been
treated for Crohn's disease with REMICADE have developed a rare type of
lymphoma that often results in death. These patients also were receiving
drugs known as azathioprine or 6- mercaptopurine. If you take REMICADE or
other TNF blockers, your risk for developing lymphoma or other cancers may
increase. You should also tell your doctor if you have had or develop
lymphoma or other cancers or if you have a lung disease called chronic
obstructive pulmonary disease (COPD).
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, swelling of your ankles or feet, or
sudden weight gain).
Reactivation of hepatitis B virus has been reported in patients who are
carriers of this virus and are taking TNF blockers, such as REMICADE. Some
of these cases have been fatal. Tell your doctor if you know or think you
may be a carrier of hepatitis B virus or if you experience signs of
hepatitis B infection, such as feeling unwell, poor appetite, tiredness,
fever, skin rash and/or joint pain.
There have been rare cases of serious liver injury in people taking
REMICADE, some fatal. Tell your doctor if you have liver problems and
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, visual disturbances or seizures while taking REMICADE.
Allergic reactions, some severe, have been reported during or after
infusions with REMICADE. Signs of an allergic reaction include hives,
difficulty breathing, chest pain, high or low blood pressure, swelling of
face and hands, and fever or chills. Tell you doctor if you have
experienced a severe allergic reaction. The most common side effects of
REMICADE are: respiratory infections, such as sinus infections and sore
throat, headache, rash, coughing, and stomach pain.
Please read the Medication Guide for REMICADE and discuss it with your
doctor.
About Centocor
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform
patients' lives. Centocor has already brought innovation to the treatment
of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic
arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.
The world leader in monoclonal antibody production and technology,
Centocor has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary
of Johnson & Johnson.
This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from Johnson & Johnson's expectations and
projections. Risks and uncertainties include general industry conditions
and competition; economic conditions, such as interest rate and currency
exchange rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms
and governmental laws and regulations; and trends toward health care cost
containment. A further list and description of these risks, uncertainties
and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual
Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of
this Form 10-K, as well as subsequent filings, are available online at
sec or on request from Johnson & Johnson. Johnson & Johnson
does not undertake to update any forward-looking statements as a result of
new information or future events or developments.
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 32,000
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 contains certain "forward-looking" statements within the meaning of
the Securities Reform Act of 1995, including statements related to REMICADE
and the potential market for REMICADE. Forward-looking statements relate to
expectations or forecasts of future events. Schering-Plough does not assume
the obligation to update any forward-looking statement. Many factors could
cause actual results to differ materially from Schering-Plough's forward-
looking statements, including market forces, economic factors, product
availability, current and future branded, generic or over-the-counter
competition and the regulatory process, among other uncertainties. For
further details and a discussion of risks and uncertainties that may affect
forward- looking statements, see the company's Securities and Exchange
Commission filings, including the company's second quarter 2006 10-Q.
References:
(1) American College of Rheumatology. Who Gets Rheumatoid Arthritis?
rheumatology/public/factsheets/ra_new.asp?aud=pat.
Accessed 10/19/06.
(2) Health and Quality of Life Outcomes. The Stanford Health Assessment
Questionnaire: Dimensions and Practical Applications.
hqlo/content/1/1/20. Accessed 10/20/06.
(3) Landewe RB, Boers M, Verhoeven AC, et al. COBRA combination therapy in
patients with early rheumatoid arthritis: long-term structural
benefits of a brief intervention. Arthritis Rheum. 2002;46:347-356.
(4) Egsmose C, Lund B, Borg G, et al. Patients with rheumatoid arthritis
benefit from early 2nd line therapy: 5 year follow up of a prospective
double blind placebo controlled study. J. Rheumatol. 1995;22:2208-
2213.
(5) American College of Rheumatology Subcommittee on Rheumatoid Arthritis
Guidelines, 2002 Update.
(6) van der Heijde DM. Joint erosions and patients with early rheumatoid
arthritis. Br J Rheumatol. 1995;34(suppl 2):74-78.
(7) Barrett EM, Scott DGI, Wiles NJ, Symmons DPM. The impact of rheumatoid
arthritis on employment status in the early years of disease: a UK
community-based study. Rheumatology. 2000;39:1403-1409.
(8) Social Security Disability Insurance Program.
Centocor, Inc.
schering-plough
View drug information on Remicade.
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