Long-Term Data in Patients Receiving Every-Four-Week Subcutaneous
SIMPONI Presented at 2009 EULAR Annual Congress COPENHAGEN, June 9
/PRNewswire/ -- Findings from open-labeled, uncontrolled extensions
of two randomized, placebo-controlled Phase 3 studies showed that
subcutaneous (SC) injections of SIMPONI(TM) (golimumab) 50 mg or
100 mg every four weeks provided persistent improvements in the
signs and symptoms in patients with psoriatic arthritis (PsA) and
ankylosing spondylitis (AS). Investigators reported these new data
from the long term treatment extensions of the GO-REVEAL and
GO-RAISE trials at the 2009 European League Against Rheumatism
(EULAR) Annual Congress. In the Golimumab - A Randomized EValuation
of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a
Human Anti-TNF MonocLonal Antibody (GO-REVEAL) study, patients with
active PsA were randomized to placebo (n=113), SIMPONI 50 mg
(n=146) or SIMPONI 100 mg (n=146). Of the 405 patients originally
randomized in the Phase 3 study, a two-year observational analysis
of 276 patients remaining in the study and evaluated at two years
was performed. Sixty-four of 70 patients who received SIMPONI 50 mg
and 95 of 130 patients who received SIMPONI 100 mg achieved ACR 20,
respectively. Forty-three of 76 patients receiving SIMPONI 50 mg
who switched to SIMPONI 100 mg in early escape also achieved ACR
20. At least 50 percent improvement in arthritis signs and symptoms
(ACR 50) was seen in 47 of 70 patients receiving SIMPONI 50 mg and
70 of 130 patients receiving SIMPONI 100 mg, respectively, while 70
percent improvement (ACR 70) was seen in 31 of 70 patients and 48
of 130 patients in the SIMPONI 50 mg and 100 mg dose groups,
respectively. In a similar analysis, SIMPONI-treated patients also
experienced sustained improvements in skin manifestations of PsA
through two years. Patients with greater than three percent Body
Surface Area (BSA) psoriasis skin involvement at baseline (n=296)
were evaluated for Psoriatic Area and Severity Index (PASI)
responses. Of the 296 patients who had at least three percent BSA
involved with skin symptoms of PsA, 200 were evaluated at two
years. PASI 75 was also observed in 33 of 48 patients receiving
SIMPONI 50 mg who did not change dose and 73 of 96 patients
receiving SIMPONI 100 mg. Thirty-five of 56 patients receiving
SIMPONI 50 mg who switched to SIMPONI 100 mg in early escape also
achieved PASI 75. "According to our findings, patients receiving
golimumab 50 mg or 100 mg experienced sustained improvements in the
signs and symptoms of psoriatic arthritis through two years of
treatment," said Iain B. McInnes, MD, PhD, FRCP, Professor of
Experimental Medicine, University of Glasgow, study investigator.
"These findings demonstrate the promise and utility of golimumab in
treating both the joint and skin manifestations of this disease."
In the open-label, uncontrolled extension of the Golimumab - A
Randomized Study in Ankylosing Spondylitis Subjects of a Novel
Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE)
study, patients receiving every-four-week subcutaneous treatment
with SIMPONI experienced sustained improvements in the signs and
symptoms of AS. As in the GO-REVEAL study, the GO-RAISE findings
were based on observed data only, in patients who were followed
through two years. Of the 356 patients originally randomized, 286
were evaluated at two years. Improvements in the Assessment in
Ankylosing Spondylitis criteria (ASAS 20) were maintained through
two years in each of the study arms: -- SIMPONI 50 mg after switch
from placebo at week 16 (24 of 31 patients) -- SIMPONI 50 mg after
switch from placebo at week 24 (28 of 31 patients) -- SIMPONI 50 mg
only (77 of 90 patients) -- SIMPONI 50 mg to 100 mg (7 of 16
patients) -- SIMPONI 100 mg combined (91 of 118 patients) "In the
GO-RAISE trial, treatment with golimumab provided sustained symptom
relief to patients living with the chronic inflammatory disease,
ankylosing spondylitis," said Jurgen Braun, MD, lead physician at
the Rheumazentrum Ruhrgebiet, Professor of Rheumatology at the Free
University of Berlin, lead study investigator. "As seen in this
study, the possibilities of this new anti-TNF-alpha therapy are
encouraging for both the physician and rheumatology patient
communities." In similar analyses from GO-RAISE, investigators also
reported that study patients receiving SIMPONI showed sustained
improvements in spinal and hip mobility through two years as
measured by the Bath Ankylosing Spondylitis Metrology Index
(BASMI). Improvements in Mental Component Summary (MCS) and
Physical Component Summary (PCS) Short Form (SF)-36 questionnaire
scores were also maintained through two years. "The sustained
symptom relief demonstrated in these Phase 3 studies is
encouraging," said Robert J. Spiegel, MD, chief medical officer,
Schering-Plough Research Institute. "The sustained efficacy and
safety SIMPONI demonstrated through two years of observation
further support the positive benefit of SIMPONI in patients with
psoriatic arthritis and ankylosing spondylitis." About the
GO-REVEAL Trial The GO-REVEAL trial involved 405 adults with
psoriatic arthritis. Patients with at least 3 swollen and tender
joints and active psoriatic skin lesions of at least two cm in
diameter were randomly assigned to receive SC injections of placebo
or SIMPONI (50 or 100 mg) every four weeks for two years. The
primary endpoint was ACR 20 response at week 14 for combined
SIMPONI groups and individual SIMPONI dose groups vs. placebo. At
week 16, patients with inadequate arthritis response were switched
to SIMPONI 50 mg (patients originally receiving placebo) or SIMPONI
100 mg (patients originally receiving SIMPONI 50 mg). All patients
received SIMPONI from week 24. The trial was unblinded to
investigators and patients after all patients reached week 52 and
the week 52 database was locked. Investigators could choose to dose
escalate patients receiving SIMPONI 50 mg to 100 mg based on
clinical judgment. The primary endpoint was ACR 20 response at week
14 for combined SIMPONI groups and individual SIMPONI dose groups
vs. placebo. Through two years, SIMPONI was generally
well-tolerated, with nine percent of SIMPONI-treated patients
experiencing serious adverse events. Injection site reactions
occurred in eight percent of patients receiving SIMPONI. There were
no reports of tuberculosis, and one case of histoplasmosis in a
patient (SIMPONI 100 mg) living in an endemic area was successfully
treated. Malignancies reported through week 104 included basal cell
skin cancer (one patient), colon cancer (one patient) and small
cell lung cancer (one patient) in patients receiving SIMPONI 50 mg,
and basal cell skin cancer (three patients), prostate cancer (one
patient), and small cell lung cancer (one patient) in patients
receiving SIMPONI 100 mg. Two patients died through two years, one
due to a climbing accident (SIMPONI 50 mg) and one due to small
cell lung cancer (SIMPONI 100 mg). About the GO-RAISE Trial The
GO-RAISE trial included 356 patients with active ankylosing
spondylitis. Patients were randomized to receive subcutaneous
injections of SIMPONI 50 mg or 100 mg or placebo every four weeks.
The primary endpoint was the proportion of patients achieving ASAS
20 at week 14. At week 16, patients in the placebo or 50 mg group
demonstrating less than 20 percent improvement from baseline in
both total back pain and morning stiffness measures were switched
to either SIMPONI 50 mg (previously receiving placebo) or SIMPONI
100 mg (previously receiving SIMPONI 50 mg). At week 24, patients
still receiving placebo were switched to SIMPONI 50 mg. Through two
years, SIMPONI was generally well tolerated, with 11 percent of
SIMPONI-treated patients experiencing serious adverse events.
Injection site reactions occurred in 11 percent of patients
receiving SIMPONI. There was one case of pulmonary tuberculosis in
a patient (SIMPONI 100 mg). Malignancies reported through week 104
consisted of two basal cell skin cancers (one patient on SIMPONI
100 mg, one placebo patient). No deaths occurred. The GO-REVEAL and
GO-RAISE studies were supported by Centocor Ortho Biotech Inc. and
Schering-Plough Corporation. About Psoriatic Arthritis Psoriatic
arthritis is a chronic inflammatory arthropathy manifesting with
joint pain and swelling that can lead to joint destruction and
debilitation. It is frequently associated with inflamed, scaly, red
patches of skin psoriasis and psoriasis nail involvement. Symptoms
may include stiffness and tenderness of the joints and surrounding
tissue and reduced range of motion. Joints of the hands, wrists,
knees, ankles, feet, lower back and neck are commonly affected.
Psoriasis affects an estimated two to three percent of the world's
population, and approximately one out of three patients affected by
psoriasis may develop psoriatic arthritis. Both men and women are
equally affected by psoriatic arthritis, most commonly between the
ages 30 and 50, in the peak of their productive years. About
Ankylosing Spondylitis AS is a painful and progressive form of
spinal arthritis, and symptoms of inflammatory back pain often
first present in people under the age of 35 years. It typically
begins in the late teens and early twenties and in severe cases can
result in fusing of the spinal vertebrae and 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 Spondylitis
Association of America estimates that between 350,000 and one
million people in the US suffer from AS. About SIMPONI SIMPONI is a
human monoclonal antibody that targets and neutralizes excess
TNF-alpha, a protein that when overproduced in the body, due to
chronic inflammatory diseases, can cause inflammation and damage to
bones, cartilage and tissue. The first once-monthly subcutaneous
anti-TNF-alpha therapy, SIMPONI is approved in Canada and the
United States and is available either through the SIMPONI
SmartJect(TM) autoinjector or a prefilled syringe. The approved
dose for SIMPONI in the US and Canada is a 50 mg subcutaneous
injection given once a month. Indications in the US: In the United
States, SIMPONI is indicated for the treatment of moderately to
severely active rheumatoid arthritis in adults, in combination with
methotrexate; active psoriatic arthritis in adults, alone or in
combination with methotrexate; and active ankylosing spondylitis in
adults. Indications in Canada: In Canada, SIMPONI, in combination
with methotrexate (MTX), is indicated for reducing the signs and
symptoms in adult patients with moderately to severely active RA;
reducing signs and symptoms in adult patients with moderately to
severely active PsA, alone or in combination with MTX; and reducing
signs and symptoms in adult patients with active AS who have had an
inadequate response to conventional therapies. SIMPONI is also
being studied as an intravenous infusion therapy for the treatment
of moderately to severely active rheumatoid arthritis. In March
2008, Centocor Ortho Biotech Inc. and Schering-Plough Corporation
announced that a Marketing Authorization Application (MAA) had been
submitted to the European Medicines Agency (EMEA) requesting the
approval of SIMPONI as a once-monthly subcutaneous treatment for
adults with RA, PsA and AS. Centocor Ortho Biotech Inc. developed
and discovered SIMPONI and has exclusive marketing rights to the
product in the United States. Following regulatory approvals,
Schering-Plough will assume exclusive marketing rights outside the
United States except in Japan, Indonesia and Taiwan, where SIMPONI
will be co-marketed by Mitsubishi Tanabe Pharma Corporation and
Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where SIMPONI
will be exclusively marketed by Janssen-Cilag; and China, where
SIMPONI will be exclusively marketed by Xian-Janssen. Important
Safety Information SIMPONI(TM) is a prescription medicine.
SIMPONI(TM) can lower your ability to fight infections. There are
reports of serious infections caused by bacteria, fungi, or viruses
that have spread throughout the body, including tuberculosis (TB)
and histoplasmosis. Some of these infections have been fatal. Your
doctor will test you for TB before starting SIMPONI(TM) and will
monitor you for signs of TB during treatment. Tell your doctor if
you have been in close contact with people with TB. Tell your
doctor if you have been in a region (such as the Ohio and
Mississippi River Valleys and the Southwest) where certain fungal
infections like histoplasmosis or coccidioidomycosis are common.
You should not start SIMPONI(TM) if you have any kind of infection.
Tell your doctor if you are prone to or have a history of
infections or have diabetes. You should also tell your doctor if
you are currently being treated for an infection or if you have or
develop any signs of an infection such as: -- fever, sweat, or
chills -- muscle aches -- cough -- shortness of breath -- blood in
phlegm -- weight loss -- warm, red, or painful skin or sores on
your body -- diarrhea or stomach pain -- burning when you urinate
or urinate more than normal -- feel very tired Tell your doctor
about all the medications you take or if you are scheduled to or
recently received a vaccine. Reactivation of hepatitis B virus has
been reported in patients who are carriers of this virus and are
taking TNF blocker medicines, such as SIMPONI(TM). Some of these
cases have been fatal. Your doctor may do blood tests before and
after you start treatment with SIMPONI(TM). 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: -- feel very
tired -- skin or eyes look yellow -- little or no appetite --
vomiting -- muscle aches -- dark urine -- clay-colored bowel
movements -- fevers -- chills -- stomach discomfort -- skin rash If
you take SIMPONI(TM) or other TNF blockers, your risk for
developing lymphoma or other cancers may increase. You should tell
your doctor if you have had or develop lymphoma or other cancers.
Heart failure can occur or get worse in people who use TNF blockers
like SIMPONI(TM). Your doctor will monitor you closely if you have
heart failure. Tell your doctor right away if you get new or
worsening symptoms of heart failure like shortness of breath or
swelling of your lower legs or feet. Rarely, people using TNF
blockers can have nervous system problems such as multiple
sclerosis. Tell your doctor right away if you have symptoms like
vision changes, weakness in your arms or legs, or numbness or
tingling in any part of your body. Liver problems can happen in
people using TNF blockers. Contact your doctor immediately if you
develop symptoms such as feeling very tired, skin or eyes look
yellow, poor appetite or vomiting, or pain on the right side of
your stomach. Low blood counts have been seen with people using TNF
blockers. If this occurs, your body may not make enough blood cells
to help fight infections or help stop bleeding. Your doctor will
check your blood counts before and during treatment. Tell your
doctor if you have signs such as fever, bruising, bleeding easily,
or paleness. Rarely, people using TNF blockers have developed
lupus-like symptoms. Tell your doctor if you have any symptoms such
as a rash on your cheeks or other parts of the body, sensitivity to
the sun, new joint or muscle pain, becoming very tired, chest pain
or shortness of breath, swelling of the feet, ankles, and/or legs.
Tell your doctor if you are allergic to rubber or latex. The needle
cover contains dry natural rubber. Tell your doctor if you have any
symptoms of an allergic reaction while taking SIMPONI(TM) such as
hives, swollen face, breathing trouble, or chest pain. Common side
effects of SIMPONI(TM) include: upper respiratory tract infection,
nausea, abnormal liver tests, redness at site of injection, high
blood pressure, bronchitis, dizziness, sinus infection, flu, runny
nose, fever, cold sores, numbness or tingling. You are encouraged
to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088. The Full
Prescribing Information and Medication Guide for SIMPONI will be
available at http://www.simponi.com/. About Centocor Ortho Biotech
Inc. Centocor Ortho Biotech Inc. redefines the standard of care in
immunology, nephrology, and oncology. The company was created when
Ortho Biotech Inc. merged into Centocor, Inc., and Centocor, Inc.
was renamed Centocor Ortho Biotech Inc. Built upon a pioneering
history, Centocor Ortho Biotech Inc. harnesses innovations in
large-molecule and small-molecule research to create important new
therapeutic options. Beyond its innovative medicines, Centocor
Ortho Biotech is at the forefront of developing education and
public policy initiatives to ensure patients and their families,
caregivers, advocates, and healthcare professionals have access to
the latest treatment information, support services, and quality
care. For more information about Centocor Ortho Biotech, visit
http://www.centocororthobiotech.com/. Centocor Ortho Biotech 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 Centocor
Ortho Biotech Inc. and/or 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 28, 2008. Copies of this Form 10-K, as well as
subsequent filings, are available online at http://www.sec.gov/,
http://www.jnj.com/ or on request from Johnson & Johnson.
Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson
undertake to update any forward-looking statements as a result of
new information or future events or developments.) About
Schering-Plough Schering-Plough (headquartered in the US) is an
innovation-driven, science-centered global health care company.
Through its own biopharmaceutical research and collaborations with
partners, Schering-Plough creates therapies that help save and
improve lives around the world. The company applies its
research-and-development platform to human prescription and
consumer products as well as to animal health products.
Schering-Plough's vision is to "Earn Trust, Every Day" with the
doctors, patients, customers and other stakeholders served by its
colleagues 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 includes certain "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements relating to the potential market for SIMPONI.
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 about these and other factors
that may impact the forward-looking statements, see
Schering-Plough's Securities and Exchange Commission filings,
including Item 1A. "Risk Factors" in Schering-Plough's 2009 10-Q,
filed May 1, 2009. DATASOURCE: Centocor Ortho Biotech Inc. CONTACT:
Media, Brian Kenney of Centocor Ortho Biotech Inc.,
+1-215-325-2107, or mobile, +1-215-620-0111; or Catherine Cantone
of Schering-Plough, +1-908-298-3944, or mobile, +1-908-327-3013; or
Investors, Tina Pinto of Johnson & Johnson, +1-732-524-2034; or
Janet Barth or Joe Romanelli, both of Schering-Plough,
+1-908-298-7436 Web Site: http://www.simponi.com/
http://www.centocororthobiotech.com/
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