First-of-its-Kind Study Demonstrates REMICADE More Likely to
Maintain Steroid-Free Remission in Patients Naive to
Immunomodulators and BiologicTherapy CHICAGO, June 2 /PRNewswire/
-- New long-term findings from the Phase 3b study of patients with
moderately to severely active Crohn's disease having inadequate
response to conventional therapies, but naive to immunomodulators
and biologic therapy, were presented at Digestive Disease Week
today. Data from the SONIC study showed that a greater proportion
of patients receiving REMICADE (infliximab) maintained steroid-free
remission at one year, compared with patients receiving
azathioprine alone. "The new, year-long data reinforce earlier 26
week findings from the SONIC trial and support the importance of
this first-of-its-kind study for treating Crohn's disease," said
Dr. Jean-Frederic Colombel, Professor of Hepatogastroenterology,
Centre Hospitalier Universitaire Lille, France, study investigator.
"The data further support the use of REMICADE earlier in the
treatment of moderate to severe Crohn's disease and its
effectiveness in patients maintaining steroid-free remission
through one year." The SONIC clinical trial is the first of its
kind to compare REMICADE, an anti-tumor necrosis factor (TNF)-alpha
therapy, with an immunomodulator (azathioprine) in patients with
moderate to severe Crohn's disease. Azathioprine is not approved by
the U.S. Food and Drug Administration (FDA) for the treatment of
Crohn's disease; however, it is widely used by gastroenterologists
and other physicians in the United States to treat patients with
Crohn's disease. Azathioprine is approved for the treatment of
Crohn's disease in some countries outside the United States.
Patients participating in the SONIC study through 30 weeks were
given the option of continuing in a blinded study extension through
54 weeks. The proportion of patients achieving steroid-free
remission among the overall randomized population (N=508),
including individuals who did not enter the study extension and
were assumed to be non-responders to therapy or not in steroid-free
remission at week 50, was 46 percent of patients receiving REMICADE
and azathioprine combination therapy, and 35 percent of patients
receiving REMICADE monotherapy, compared with 24 percent of
patients receiving azathioprine alone (P < 0.001 REMICADE with
azathioprine vs. azathioprine monotherapy; P = 0.028 REMICADE
monotherapy vs. azathioprine monotherapy; P = 0.035 REMICADE with
azathioprine vs. REMICADE monotherapy). In an analysis of only
those individuals participating in the extension (N=280), 72
percent of patients receiving REMICADE and azathioprine combination
therapy, 61 percent of patients receiving REMICADE monotherapy and
55 percent receiving azathioprine alone achieved steroid-free
remission at week 50 (P = 0.010 REMICADE and azathioprine vs.
azathioprine monotherapy; P = 0.324 REMICADE monotherapy vs.
azathioprine monotherapy; P = 0.065 REMICADE and azathioprine vs.
REMICADE monotherapy). A final safety evaluation for those patients
who entered the extension study occurred at week 54. The proportion
of patients with 1 or more serious adverse events during the study
was 27 percent (n=43) in the AZA monotherapy treatment group, 24
percent (n=39) in the REMICADE monotherapy treatment group, and 15
percent (n=27) in the combined REMICADE and AZA treatment group. No
new serious adverse events, such as opportunistic infections,
malignancies or death, were reported between weeks 30 and 54. Dr.
William J. Sandborn, Inflammatory Bowel Disease Clinic, Mayo
Clinic, and principal investigator for the SONIC trial, will
present the results of the SONIC extension trial on Tuesday, June 2
at 3:30 PM at the annual Digestive Disease Week meeting. In 1998,
REMICADE became the first anti-TNF-alpha therapy approved by the
FDA for the treatment of moderately to severely active Crohn's
disease for the reduction of the signs and symptoms in patients who
have an inadequate response to conventional therapy. During the
past decade, REMICADE has also become the first and only
anti-TNF-alpha therapy approved by the FDA for the treatment of
moderately to severely active ulcerative colitis, in patients with
an inadequate response to conventional therapy, a related
inflammatory bowel disease. REMICADE is also approved for the
treatment of pediatric patients with moderately to severely active
Crohn's disease who have had an inadequate response to conventional
therapies. The SONIC study was supported by Centocor Ortho Biotech,
Inc. About SONIC SONIC was a multicenter, Phase 3b, randomized,
double-blind, controlled clinical trial designed to compare the
efficacy and safety of REMICADE monotherapy, azathioprine
monotherapy and combination therapy with the 2 drugs in patients
with moderately to severely active Crohn's disease who were naive
to immunomodulator and biologic therapy. A total of 508 patients
from the U.S., Europe and Israel were enrolled in the study and
were randomized into three groups; 170 patients received
azathioprine less than or equal to 2.5 mg/kg/day and placebo
infusions, 169 patients received REMICADE 5 mg/kg infusions at
weeks 0, 2, 6 and every 8 weeks thereafter with placebo capsules
and 169 patients received REMICADE 5 mg/kg and azathioprine less
than or equal to 2.5 mg/kg/day at week 26. The primary endpoint of
SONIC was to assess the induction of steroid-free remission at week
26. Patients completing treatment through week 30, and who, in the
opinion of the investigator, may benefit from continued treatment,
entered into the study extension beginning at week 30 through week
50. SONIC previously demonstrated the effect of REMICADE therapy on
steroid-free remission and complete mucosal healing, the healing of
the lining of the bowel, at week 26. Results from the 26 week data
showed that 57 percent of patients receiving REMICADE combination
therapy and 44 percent receiving REMICADE monotherapy achieved
clinical remission without steroids compared with 31 percent of
patients receiving azathioprine alone (P < 0.001 REMICADE with
azathioprine vs. azathioprine monotherapy; P = 0.009 REMICADE
monotherapy vs. azathioprine monotherapy; P = 0.022 REMICADE with
azathioprine vs. REMICADE monotherapy). Additionally, mucosal
healing was achieved in 44 percent of patients receiving REMICADE
combination therapy and 30 percent receiving REMICADE monotherapy
achieved mucosal healing compared with 17 percent of patients
receiving azathioprine alone (P < 0.001 REMICADE with
azathioprine vs. azathioprine monotherapy; P = 0.023 REMICADE
monotherapy vs. azathioprine monotherapy; P = 0.055 REMICADE with
azathioprine vs. REMICADE monotherapy). Through the first 26 weeks
in SONIC, 24 percent of patients receiving azathioprine monotherapy
experienced one or more serious adverse events compared with 16 and
14 percent of patients receiving REMICADE monotherapy and REMICADE
with azathioprine, respectively. Two patients receiving
azathioprine monotherapy developed colon cancer, one patient
receiving azathioprine monotherapy died following a colectomy and
one patient receiving REMICADE combination therapy was diagnosed
with tuberculosis. Serious infections were reported as follows: 8
in the azathioprine monotherapy group, 4 in the REMICADE
monotherapy group and 6 in the REMICADE combination therapy group.
There were no deaths, malignancies or reports of tuberculosis
during the study extension. For more information regarding the
safety profile for REMICADE, please see "Important Safety
Information" below. About Crohn's Disease Crohn's disease, a
chronic inflammatory disease of the gastrointestinal tract, affects
approximately 500,000 Americans, including approximately 150,000
pediatric patients. The cause of Crohn's disease is not known, but
the disease is associated with abnormalities of the immune system
that could be triggered by a genetic predisposition or diet and
other environmental factors. Symptoms of Crohn's disease can vary
but often include abdominal pain and tenderness, frequent diarrhea,
rectal bleeding, weight loss and fever. There is currently no cure
for Crohn's disease. About REMICADE REMICADE was the first
anti-TNF-alpha treatment to be approved in three different
therapeutic areas: gastroenterology, rheumatology and dermatology.
REMICADE has demonstrated broad clinical utility with indications
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). The
safety and efficacy of REMICADE have been well established in
clinical trials over the past 16 years and through commercial
experience with more than one million patients treated worldwide.
In the U.S., REMICADE is approved for the following indications: --
Reducing signs and symptoms, inhibiting the progression of
structural damage and improving physical function in patients with
moderately to severely active RA, when administered in combination
with methotrexate. -- Reducing signs and symptoms in patients with
active AS. -- 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. -- Reducing the number of
draining enterocutaneous and rectovaginal fistulas and maintaining
fistula closure in adult patients with fistulizing CD. -- Reducing
signs and symptoms, inducing and maintaining 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. -- Reducing signs and symptoms of
active arthritis, inhibiting the progression of structural damage
and improving physical function in patients with PsA. -- Treatment
of adult patients with chronic severe plaque PsO who are candidates
for systemic therapy and when other systemic therapies are
medically less appropriate. REMICADE is unique among available
anti-TNF biologic therapies. It is the only anti-TNF biologic
administered directly by caregivers in the clinic or office
setting. REMICADE is a two-hour infusion administered every 6 or 8
weeks (indication-dependent), 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.
Important Safety Information Only a doctor can recommend a course
of treatment after checking a patient's health condition. A doctor
should discuss any potential benefits and risks and help make the
best treatment decision on a patient by patient basis. Like other
medicines that affect the immune system, REMICADE can cause serious
side effects such as lowering a patient's ability to fight
infections. There are reports of serious infections caused by
viruses, fungi or bacteria that have spread throughout the body,
including tuberculosis (TB) and histoplasmosis. Some of these
infections have been fatal. Doctors should monitor closely for
signs and symptoms of TB during treatment with REMICADE. Patients
should discuss any concerns about their health and medical care
with their doctor. Patients should let their doctors know if they
have or ever had any of the following: -- Tuberculosis (TB) or have
been near someone who has TB. Doctors will check for TB with a skin
test. If a patient has latent (inactive) TB, TB treatment should
begin before starting REMICADE. -- Lived in a region where certain
fungal infections like histoplasmosis or coccidioidomycosis are
common. -- An infection that keeps coming back (or any problems
that increase the risk of infection) or have diabetes. -- Any type
of cancer or a risk factor for developing cancer, for example,
chronic obstructive pulmonary disease (COPD) or had phototherapy
for psoriasis. -- Heart failure or any heart condition. Many people
with heart failure should not take REMICADE. -- Hepatitis B virus
(HBV) infection or think you may be a carrier of HBV. -- Nervous
system disorders (like multiple sclerosis or Guillain-Barre
syndrome). Patients should tell their doctors about any medications
they are taking, including vaccines or Kineret (anakinra), and if a
woman is pregnant, plans to become pregnant or is nursing. Adults
and children should not receive a live vaccine while taking
REMICADE. The following serious (sometimes fatal) side effects have
been reported in people taking REMICADE. Patients should tell their
doctors right away if you have any of the signs listed below: --
Infections (like TB, blood infections, pneumonia) - fever,
tiredness, cough, flu, or warm, red or painful skin or any open
sores. REMICADE(R) can make patients more likely to get an
infection or make any current infection worse. -- Lymphoma, or any
other cancers. A rare form of fatal lymphoma has occurred mostly in
teenage or young adult males with Crohn's disease or ulcerative
colitis who were taking REMICADE and azathioprine or
6-mercaptopurine. -- Heart failure - new or worsening symptoms,
such as shortness of breath, swelling of ankles or feet, or sudden
weight gain. -- Reactivation of HBV - feeling unwell, poor
appetite, tiredness, fever, skin rash and/or joint pain. -- Liver
injury - jaundice (yellow skin and eyes), dark brown urine,
right-sided abdominal pain, fever, or severe tiredness. -- Blood
disorders - fever that doesn't go away, bruising, bleeding or
severe paleness. -- Nervous system disorders - numbness, weakness,
tingling, changes in your vision or seizures. -- Allergic reactions
during or after the infusion - hives, difficulty breathing, chest
pain, high or low blood pressure, swelling of face and hands, and
fever or chills. -- Lupus-like syndrome - chest discomfort or pain
that does not go away, shortness of breath, joint pain, rash on the
cheeks or arms that gets worse in the sun. The more common side
effects with REMICADE are respiratory infections (that may include
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/. About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in
immunology, nephrology and oncology. The company was formed when
Centocor, Inc. and Ortho Biotech Inc. were consolidated in late
2008, and 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/. DATASOURCE: Centocor
Ortho Biotech Inc. CONTACT: Investor Relations: Tina Pinto of
Johnson & Johnson, +1-732-524-2034 (office), or Media: Brian
Kenney of Centocor Ortho Biotech Inc., +1-215-325-2107(office), or
+1-215-620-0111 (cell) Web Site:
http://www.centocororthobiotech.com/
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