Data presented
today at the European League Against Rheumatism (EULAR) Annual European
Congress of Rheumatology showed that patients with ankylosing spondylitis
(AS) who received REMICADE(R) (infliximab) over two years experienced
significant improvement in spinal mobility. In addition, REMICADE-treated
patients showed sustained reductions in spinal inflammation through two
years as detected by magnetic resonance imaging (MRI).
The recommended dose of REMICADE in AS is 5 mg/kg given as an IV
induction regimen at 0, 2 and 6 weeks followed by a 5 mg/kg maintenance
regimen every 6 weeks in the United States or every 6-8 weeks in the
European Union.
AS is a progressive rheumatic disease that leads to inflammation of the
back, resulting in pain, stiffness and reduced mobility, which in advanced
cases can result in fusion of the vertebrae of the spine ('ankylosis').
Data collected from 279 patients with AS as part of the Ankylosing
Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy
(ASSERT) trial were analyzed to determine the long-term effect of REMICADE
on spinal mobility. The double-blind extension of this 24-week
placebo-controlled study utilized the Bath Ankylosing Spondylitis Metrology
Index (BASMI) and chest expansion measurements to assess range of motion in
patients with AS.
Patients in ASSERT were treated and assessed at six week intervals
through week 102. According to the findings, compared with placebo group
(N=78), at week 24 the REMICADE-treated patients (N=201) had a greater
improvement in BASMI (defined as a change of at least 1 in the BASMI score)
scores (-0.7 vs. -0.2, respectively; P = 0.02), and in percent change in
chest expansion (44 percent vs. 19 percent, respectively, P = 0.03).
Fifty-one percent of REMICADE-treated patients vs. 31 percent of
placebo-treated patients achieved a clinically meaningful improvement in
BASMI (P < 0.01). The improvement seen at week 24 was maintained through
week 102 in those patients who continued in the trial extension (N=161).
Furthermore, after crossing over to receive treatment with REMICADE at week
24 following initial treatment with placebo, patients experienced similar
improvements in BASMI and chest expansion scores as patients in the
REMICADE group at weeks 54, 78 and 102.
"Ankylosing spondylitis can limit spinal mobility and significantly
impair a patient's quality of life. These data demonstrate that treatment
with REMICADE improved spinal mobility. Over time, this improvement can be
maintained when REMICADE is coupled with physiotherapy," said Professor
Jurgen Braun, M.D., lead physician at the Rheumazentrum Ruhrgebiet and
Professor of Rheumatology at the Free University of Berlin. "In studying
the same group of patients, REMICADE therapy also had a positive effect on
spinal inflammation, a common and debilitating manifestation of ankylosing
spondylitis."
In ASSERT spinal inflammation as detected by MRI was examined. Patients
receiving REMICADE showed improvement in MRI Activity scores at week 24,
which was sustained through week 102 in those patients who continued in the
trial extension (N=161). Patients initially in the placebo group showed no
change in MRI Activity scores at week 24, but scores improved after
crossing over to receive treatment with REMICADE. The relationship of
spinal inflammation as measured by activity scores on MRI to long-term
structural damage in AS is unknown.
About ASSERT
In ASSERT (Ankylosing Spondylitis [AS] Study for the Evaluation of
Recombinant Infliximab Therapy), 279 patients with AS for at least three
months, radiographic evidence of sacroiliitis and symptoms of active
disease (BASDAI of at least 4 and visual analog scale for spinal pain of at
least 4, each on a scale of one to 10) were randomized to receive infusions
of REMICADE 5 mg/kg at weeks 0, 2 and 6 and every six weeks thereafter
through week 96 (n = 201) or placebo (n = 78). The primary endpoint of the
trial was a 20 percent decrease in disease activity score on the Assessment
in Ankylosing Spondylitis Response Criteria (ASAS 20) at week 24.
At week 24, placebo patients were crossed over to receive treatment
with REMICADE 5 mg/kg at weeks 0, 2 and 6 and every six weeks thereafter
and continued on REMICADE through the remainder of the study (96 weeks).
Starting at week 36, and continuing through week 96, patients initially
randomized to receive REMICADE 5 mg/kg had their dose increased to 7.5
mg/kg if they had a BASDAI of at least 3 in two consecutive evaluations to
assess the potential for improved response through increased dosing. Using
these rather strict criteria, 106 patients (53 percent) received a dose
increase some time after week 30.
Nine percent of patients who received REMICADE through week 102
discontinued the study due to adverse events (AEs). During the study,
REMICADE was generally well-tolerated. At week 24, the most commonly
reported AEs were upper respiratory tract infections, which occurred at a
rate of 15 percent in the placebo group, compared with 14 percent in the
REMICADE group. The only laboratory abnormalities that occurred more
frequently with REMICADE compared with placebo were asymptomatic liver
enzyme test elevations. At week 24, serious (AEs) were reported in 4
percent of REMICADE-treated patients, compared with three percent of
patients receiving placebo. AEs were generally mild and were consistent
with REMICADE prescribing information.
There were no reports of congestive heart failure, tuberculosis or
serious infections in the study population. Three malignancies were
reported in three patients during the ASSERT study and included squamous
cell skin cancer, lung cancer and breast cancer. Please see "Important
Safety Information" below.
About Ankylosing Spondylitis
AS is a painful and progressive form of spinal arthritis and symptoms
of inflammatory back pain often first present in people before age 35. It
typically begins in the late teens and early twenties and in severe cases
may result in fusing spinal vertebrae and may cause structural damage to
hips and other joints. Often misdiagnosed as "just back pain" or
undifferentiated arthritis, AS is a systemic inflammatory disease that, in
addition to its effect on the spine, can affect internal organs, peripheral
joints and vision. The Arthritis Research Campaign, estimates that on the
European continent, AS prevalence ranges from 0.2 to 1 percent of the
entire population. The Spondylitis Association of America estimates that
between 350,000 and one million people in the U.S. suffer from Ankylosing
Spondylitis.
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 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 15 years and through commercial experience with more
than 924,000 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. In May 2007,
REMICADE was approved in the EU for the treatment of severe, active Crohn's
disease (CD) in pediatric patients aged 6 to 17 years, who have not
responded to conventional therapy including a corticosteroid, an
immunomodulator and primary nutrition therapy, or who are intolert to, or
have contraindications for, such therapies.
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, or psoriatic arthritis
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. Rarely, children and young adults who have been treated for
Crohn's disease with REMICADE in combination with azathioprine or
6-mercaptopurine have developed a rare type of lymphoma, hepatosplenic T
cell lymphoma (HSTL), that often results in death. 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 your 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 important information about REMICADE, including full U.S.
prescribing information and Medication Guide, at remicade. For
complete EU prescribing information, please visit emea.eu.int.
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 December 31, 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 approximately 33,500
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 Private Securities Litigation Reform Act of 1995, including statements
related to the approval of REMICADE for CD in the EU 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, patent and other intellectual property protection, current
and future branded, generic or over-the-counter competition, the regulatory
process, and any developments following regulatory approval, among other
uncertainties. For further details and a discussion of risks and
uncertainties that may impact forward-looking statements, see
Schering-Plough's Securities and Exchange Commission filings, including
Part II, Item 1A, "Risk Factors" in the company's first quarter 2007 10-Q.
Schering-Plough and Centocor
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View drug information on Remicade.
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