Findings from the ASSERT Trial Presented at EULAR BARCELONA, Spain,
June 15 /PRNewswire-FirstCall/ -- 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 http://www.remicade.com/. For complete EU prescribing
information, please visit http://www.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 http://www.sec.gov/ 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 http://www.schering-plough.com/. 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. #46-0607
DATASOURCE: Schering-Plough and Centocor CONTACT: Media: Cathy
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