Pfizer in partnership with Celltrion
Healthcare presents new data for INFLECTRA in Crohn’s
disease
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.
“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
identified.
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 your doctor.
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 following:
- 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 problem.
- 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 syndrome).
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 taking INFLECTRA?
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 listed below:
- 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 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.
- 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:
Crohn's Disease
- 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
Ulcerative Colitis
- 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
Rheumatoid Arthritis
- 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
Ankylosing Spondylitis
- Can reduce signs and symptoms in
patients with active ankylosing spondylitis
Psoriatic Arthritis
- Can reduce signs and symptoms of active
arthritis, help stop further joint damage, and improve physical
function in patients with psoriatic arthritis
Plaque Psoriasis
- 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 (infliximab-dyyb).
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 health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us at
www.pfizer.com. In addition, to learn more, follow us on Twitter at
@Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
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 competitive
developments.
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 and www.pfizer.com.
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 2 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
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Pfizer Inc.Media:Rachel Hooper,
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