NEW YORK--(BUSINESS WIRE)--Data announced jointly today by Pfizer Inc. (NYSE:PFE) and Celltrion
Healthcare, at the 12th Congress of the European Crohn’s and
Colitis Organisation (ECCO), showed that for patients with
moderate-to-severe Crohn’s disease (CD), treatment with INFLECTRA
(infliximab CT-P13) has similar efficacy and safety to treatment with
REMICADE (infliximab).1 The randomized 54 week clinical trial
(RCT)2 in 214 patients met its primary end point
demonstrating that, at six weeks, INFLECTRA was similar to REMICADE in
the treatment of CD thereby meeting the criterion for non-inferiority.
The trial evaluated the number of patients experiencing a fall of 70
points or greater in the Crohn’s Disease Activity Index (CDAI-70), a
well-established assessment of treatment response in CD. The response
rates, 71.4% for INFLECTRA and 75.2% for REMICADE,1 were
not statistically significantly different. INFLECTRA is marketed
as INFLECTRA (infliximab-dyyb) in the United States (U.S.) and under
other brand names in some countries.
“Forward-Looking Information and Factors That May Affect Future
“Today’s presentation of randomized control trial data in patients with
Crohn’s disease further supports the existing clinical profile of CT-P13
in inflammatory bowel disease. In addition to existing data from the
registration studies, real-world experience and the NOR-SWITCH trial,
this data adds to the body of evidence supporting use of CT-P13 across
its approved indications,” said Sam Azoulay, M.D., Senior Vice
President, Chief Medical Officer, Pfizer Essential Health, Pfizer.
Additional disease activity measures used in the trial, clinical
remission and CDAI-100 response rates, demonstrated similar and
consistent efficacy between the two treatments. Six-week data also
showed that INFLECTRA had a similar safety and tolerability profile as
REMICADE. The number of patients experiencing at least one adverse
event, serious adverse events, and adverse events of special interest
(such as infusion reaction and infection) were similar between the two
treatment arms.1 No new safety signals were
Further results on the longer-term safety and efficacy of INFLECTRA from
this ongoing 54-week study in CD are expected later this year. The study
is also examining the treatment response and safety profile in patients
when switched from REMICADE to INFLECTRA, and from INFLECTRA to REMICADE.2
About the trial
This is a randomized, double-blind, parallel-group, phase III study
being conducted in patients with moderately-to-severe Crohn’s disease to
compare overall safety and efficacy between INFLECTRA and REMICADE in
terms of Crohn’s Disease Activity Index (CDAI)-70 response rates. The
primary endpoint of the 54-week study was collected at week six to
demonstrate that INFLECTRA is similar to REMICADE in the treatment of
CD. The study used the standard assessment of CDAI-70 as primary
endpoint. From Week 30, patients on REMICADE will be randomized to
either continue on the same treatment or switch to INFLECTRA while
patients on INFLECTRA will be randomized to either continue on the same
treatment or switch to the REMICADE. Further results will be collected
and reported at 54-weeks.2
ABOUT INFLECTRA: IMPORTANT SAFETY INFORMATION AND INDICATIONS FROM
THE U.S. PRESCRIBING INFORMATION
Only your doctor can recommend a course of treatment after checking your
health condition. INFLECTRA (infliximab-dyyb) can cause serious side
effects such as lowering your ability to fight infections. Some
patients, especially those 65 years and older, have had 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. Your doctor should monitor you
closely for signs and symptoms of TB during treatment with INFLECTRA.
Unusual cancers have been reported in children and teenage patients
taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, 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 infliximab
products and azathioprine or 6-mercaptopurine. For
children and adults taking TNF blockers, including INFLECTRA, the
chances of getting lymphoma or other cancers may increase.
You should discuss any concerns about your health and medical care with
What should I tell my doctor before I take INFLECTRA?
You should let your doctor know if you have or ever had any of the
Tuberculosis (TB) or have been near someone who has TB. Your doctor
will check you for TB with a skin test. If you have latent (inactive)
TB, you will begin TB treatment before you start INFLECTRA.
Lived in a region where certain fungal infections like histoplasmosis
or coccidioidomycosis are common.
Infections that keep coming back, diabetes, or an immune system
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 INFLECTRA.
Hepatitis B virus (HBV) infection or think you may be a carrier of
HBV. Your doctor will test you for HBV.
Nervous system disorders (like multiple sclerosis or Guillain-Barré
Also tell your doctor if you:
Use the medicines Kineret (anakinra), Orencia (abatacept), or Actemra
(tocilizumab) or other medicines called biologics used to treat the
same problems as INFLECTRA.
Are pregnant, plan to become pregnant, are breast-feeding, or have a
baby and were using INFLECTRA during your pregnancy. Tell your baby's
doctor about your INFLECTRA use. If your baby receives a live vaccine
within 6 months after birth, your baby may develop infections with
serious complications that can lead to death.
Recently received or are scheduled to receive a vaccine. Adults and
children taking INFLECTRA should not receive live vaccines or
treatment with a weakened bacteria (such as BCG for bladder cancer)
while taking INFLECTRA.
What should I watch for and talk to my doctor about before or while
The following serious (sometimes fatal) side effects have been reported
in people taking INFLECTRA.
You should tell your doctor right away if you have any of the signs
Infections (like TB, blood infections, pneumonia)—fever, tiredness,
cough, flu, or warm, red, or painful skin or any open sores. INFLECTRA
can make you more likely to get an infection or make any infection
that you have worse.
Lymphoma or any other cancers in adults and children.
Skin cancer—any changes in or growths on your skin.
Heart failure—new or worsening symptoms, such as shortness of breath,
swelling of your 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
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.
Psoriasis—new or worsening psoriasis such as red scaly patches or
raised bumps on the skin that are filled with pus.
The more common side effects with infliximab products are respiratory
infections (that may include sinus infections and sore throat),
headache, rash, coughing, and stomach pain.
INFLECTRA is a prescription medication used to treat:
Can reduce signs and symptoms and induce and maintain remission in
adult patients with moderately to severely active Crohn’s disease who
haven't responded well to other therapies
Pediatric Crohn's Disease
Can reduce signs and symptoms and induce and maintain remission in
children (ages 6-17) with moderately to severely active Crohn's
disease who haven't responded well to other therapies
Can reduce signs and symptoms, induce and maintain remission, promote
intestinal healing, and reduce or stop the need for steroids in adult
patients with moderately to severely active ulcerative colitis who
haven't responded well to other therapies
Can reduce signs and symptoms, help stop further joint damage, and
improve physical function in patients with moderately to severely
active rheumatoid arthritis, in combination with methotrexate
Can reduce signs and symptoms in patients with active ankylosing
Can reduce signs and symptoms of active arthritis, help stop further
joint damage, and improve physical function in patients with psoriatic
Approved for the treatment of adult patients with chronic severe
(extensive and/or disabling) plaque psoriasis under the care of a
physician who will determine if INFLECTRA is appropriate considering
other available therapies
Please see full
Prescribing Information for INFLECTRA
About Pfizer: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
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more than 150 years, Pfizer has worked to make a difference for all who
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DISCLOSURE NOTICE: The information contained in this release is as of
February 17, 2017. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information about INFLECTRA
(infliximab-dyyb), including its potential benefits, that
involves substantial risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
uncertainties regarding the commercial success of INFLECTRA; the
uncertainties inherent in research and development, including, without
limitation, the possibility of unfavorable clinical trial results,
including unfavorable new clinical data and additional analyses of
existing clinical data; intellectual property and/or litigation
implications; relationship with the application sponsor; decisions by
regulatory authorities regarding labeling and other matters that could
affect the availability or commercial potential of INFLECTRA; and
A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended December
31, 2015, including in the sections thereof captioned "Risk Factors" and
"Forward-Looking Information and Factors That May Affect Future
Results", as well as in its subsequent reports on Form 10-Q and Form
8-K, all of which are filed with the U.S. Securities and Exchange
Commission and available at www.sec.gov
a REMICADE® is a U.S. registered trademark of
Janssen Biotech, Inc.
1 Kim YH., et al., Phase III Randomised, Double-blind,
Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with
Innovator Infliximab (INX) in Patients with Active Crohn’s Disease:
Early Efficacy and Safety Results. DOP061, presented at ECCO 2017
Clinical Trials.gov. Demonstrate Noninferiority in Efficacy
and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease.
Available at: https://www.clinicaltrials.gov/ct2/show/NCT02096861?term=ct-p13+crohns&rank=1.
Last accessed February 2017