Pfizer Announces Top-Line Results from the Oral Strategy Trial of XELJANZ® (tofacitinib citrate) Compared to Humira® (adali...
February 16 2017 - 8:00AM
Business Wire
Pfizer Inc. (NYSE:PFE) announced today top-line results from
ORAL Strategy, a Phase 3B/4 study of XELJANZ® (tofacitinib citrate)
5mg twice daily (BID) in the treatment of moderate to severe
rheumatoid arthritis (RA). ORAL Strategy is the first trial to
compare a JAK inhibitor as monotherapy or in combination with
methotrexate (MTX) versus adalimumab (Humira) plus MTX in MTX
inadequate responders using ACR50 at Month 6 as the primary
endpoint. There were three comparisons, which found:
- XELJANZ 5mg plus MTX met its primary
endpoint in demonstrating non-inferiority versus Humira plus
MTX
- XELJANZ 5mg monotherapy did not meet
its primary endpoint of non-inferiority versus Humira plus MTX or
versus XELJANZ plus MTX
“ORAL Strategy is representative of the type of innovative and
clinically meaningful trials that Pfizer Inflammation &
Immunology believes are important to help advance patient care and
the science of JAK inhibition,” said Michael Corbo, Chief
Development Officer, Inflammation & Immunology, Global Product
Development. “We are pleased that we demonstrated non-inferiority
of XELJANZ plus MTX versus Humira plus MTX, reinforcing the
efficacy of XELJANZ combination therapy. We will continue to
analyze the monotherapy data from this study and look forward to
sharing the full results of ORAL Strategy at an upcoming scientific
forum.”
ORAL Strategy is a 12-month, double-blind, head-to-head study
which included 1,152 patients randomized into one of three study
arms that were independently compared against each other:
- XELJANZ 5 mg BID as monotherapy
(n=386)
- XELJANZ 5 mg BID in combination with a
weekly dose of MTX (15-25 mg) (n=378)
- Humira 40 mg every-other-week via
subcutaneous injection in combination with a weekly dose of MTX
(15-25 mg) (n=388)
The safety findings were consistent with the known adverse
events and serious adverse events profile for XELJANZ.
The RA clinical development program has over 20 clinical trials
and to-date represents more than 21,100 patient-years of drug
exposure. The long-term extension program, spanning over eight
years of safety experience, is one of the largest in the RA
category with respect to number of patients and patient-years of
exposure.
About XELJANZ (tofacitinib citrate) and XELJANZ XR
(tofacitinib citrate) extended-release
XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a
prescription medicine called a JAK inhibitor. XELJANZ has been
approved for use in more than 50 countries. Since XELJANZ was first
approved in the U.S. in 2012, it has been prescribed to more than
90,000 patients worldwide. In the United States, Argentina, and
Macau, XELJANZ XR is the first once-daily oral JAK inhibitor
approved for the treatment of moderate to severe RA.
Pfizer is committed to advancing the science of JAK inhibition
and enhancing the understanding of the efficacy and safety of
XELJANZ through robust clinical development programs in the
treatment of immune-mediated inflammatory conditions.
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate)
extended-release is a prescription medicine called a Janus kinase
(JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with
moderately to severely active rheumatoid arthritis in which
methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a
single agent or in combination with methotrexate (MTX) or other
non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of
XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent
immunosuppressants, such as azathioprine and cyclosporine, is not
recommended.
- It is not known if XELJANZ/XELJANZ XR
is safe and effective in people with hepatitis B or C.
- XELJANZ/XELJANZ XR is not for people
with severe liver problems.
- It is not known if XELJANZ/XELJANZ XR
is safe and effective in children.
Important Safety Information
- XELJANZ/XELJANZ XR can lower the
ability of the immune system to fight infections. Some people can
have serious infections while taking XELJANZ/XELJANZ XR, including
tuberculosis (TB), and infections caused by bacteria, fungi, or
viruses that can spread throughout the body. Some people have died
from these infections. Healthcare providers should test patients
for TB before starting XELJANZ/XELJANZ XR, and monitor them closely
for signs and symptoms of TB and other infections during treatment.
People should not start taking XELJANZ/XELJANZ XR if they have any
kind of infection unless their healthcare provider tells them it is
okay.
- People may be at a higher risk of
developing shingles.
- XELJANZ/XELJANZ XR may increase the
risk of certain cancers by changing the way the immune system
works. Lymphoma and other cancers, including skin cancers, can
happen in patients taking XELJANZ/XELJANZ XR.
- The risks and benefits of treatment
should be considered prior to initiating XELJANZ/XELJANZ XR in
patients with chronic or recurrent infection; who have been exposed
to tuberculosis; with a history of a serious or an opportunistic
infection; who have resided or traveled in areas of endemic
tuberculosis or endemic mycoses; or with underlying conditions that
may predispose them to infection.
- Viral reactivation, including cases of
herpes virus reactivation (e.g., herpes zoster), was observed in
clinical studies with XELJANZ.
- Use of live vaccines should be avoided
concurrently with XELJANZ/XELJANZ XR. Update immunizations in
agreement with current immunization guidelines prior to initiating
XELJANZ/XELJANZ XR therapy.
- Some people who have taken XELJANZ with
certain other medicines to prevent kidney transplant rejection have
had a problem with certain white blood cells growing out of control
(Epstein Barr virus-associated post-transplant lymphoproliferative
disorder).
- Some people taking XELJANZ/XELJANZ XR
can get tears in their stomach or intestines. This happens most
often in people who also take nonsteroidal anti-inflammatory drugs
(NSAIDs), corticosteroids, or methotrexate.
- XELJANZ/XELJANZ XR should be used with
caution in patients who may be at increased risk for
gastrointestinal perforation (e.g., patients with a history of
diverticulitis), or who have a narrowing within their digestive
tract. Patients should tell their healthcare provider right away if
they have fever and stomach-area pain that does not go away or a
change in bowel habits.
- XELJANZ/XELJANZ XR can cause changes in
certain lab test results including low blood cell counts, increases
in certain liver tests, and increases in cholesterol levels.
Healthcare providers should do blood tests before starting patients
on XELJANZ/XELJANZ XR and while they are taking XELJANZ/XELJANZ XR,
to check for these side effects. Normal cholesterol levels are
important to good heart health. Healthcare providers may stop
XELJANZ/XELJANZ XR treatment because of changes in blood cell
counts or liver test results.
- Use of XELJANZ/XELJANZ XR in patients
with severe hepatic impairment is not recommended.
- Patients should tell their healthcare
providers if they plan to become pregnant or are pregnant.
It is not known if XELJANZ/XELJANZ XR will harm an unborn baby.
To monitor the outcomes of pregnant women exposed to
XELJANZ/XELJANZ XR, a registry has been established. Physicians are
encouraged to register patients and pregnant women are encouraged
to register themselves by calling 1-877-311-8972.
- Patients should tell their healthcare
providers if they plan to breastfeed or are breastfeeding. Patients
and their healthcare provider should decide if they will take
XELJANZ/XELJANZ XR or breastfeed. They should not do both.
- In carriers of the hepatitis B or C
virus (viruses that affect the liver), the virus may become active
while using XELJANZ/XELJANZ XR. Healthcare providers may do blood
tests before and during treatment with XELJANZ/XELJANZ XR.
- Common side effects include upper
respiratory tract infections (common cold, sinus infections),
headache, diarrhea, and nasal congestion, sore throat, and runny
nose (nasopharyngitis).
Please click the direct link to the full US Prescribing
Information for XELJANZ/XELJANZ XR, including Boxed Warning and
Medication Guide:
http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
Pfizer Inc.: 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 healthcare
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer healthcare
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
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on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this
release is as of February 16, 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 XELJANZ
(tofacitinib citrate) 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, the uncertainties
inherent in research and development, including, without
limitation, the ability to meet anticipated trial commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; uncertainties regarding the commercial success of
XELJANZ and XELJANZ XR; uncertainties regarding the commercial
impact of the results of the ORAL Strategy trial; whether and when
any other applications for XELJANZ or XELJANZ XR may be filed with
regulatory authorities in any jurisdictions; whether and when
regulatory authorities in any jurisdictions may approve any such
applications and/or any other applications that are pending
(including the marketing authorization application currently under
review by the European Medicines Agency for the treatment of
moderate to severe active RA in adult patients who have responded
inadequately to, or who are intolerant to one or more
disease-modifying antirheumatic drugs. XELJANZ can be given as
monotherapy in case of intolerance to MTX or when treatment with
MTX is inappropriate) or may be filed for XELJANZ or XELJANZ XR,
which will depend on the assessment by such regulatory authorities
of the benefit-risk profile suggested by the totality of the
efficacy and safety information submitted; decisions by regulatory
authorities regarding labeling and other matters that could affect
the availability or commercial potential of XELJANZ/XELJANZ XR; 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 and in its subsequent reports on Form 10-Q,
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 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.
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Pfizer Inc.Media:Steven Danehy,
978-273-3946Steven.Danehy@pfizer.comorInvestors:Chuck Triano,
212-733-3901Charles.E.Triano@pfizer.com
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