Pfizer Inc. (NYSE:PFE) announced that three abstracts for
XELJANZ® (tofacitinib citrate), being investigated in moderate to
severe ulcerative colitis (UC), will be presented at the upcoming
United European Gastroenterology Week (UEG Week 2016), October
15-19 in Vienna, Austria. The tofacitinib presentations will
highlight new research results from the Phase 3 Oral
Clinical Trials for tofAcitinib in
ulceratiVE colitis (OCTAVE) Induction trials, including one
oral presentation looking at the effect of prior treatment with
tumor necrosis factor inhibitors (TNFi) on efficacy endpoints. In
addition, two abstracts have been accepted as poster presentations,
highlighting results by endoscopic response, and onset of action,
respectively.
“The new data to be presented at UEG Week deepen our
understanding of the efficacy and safety profile of tofacitinib in
ulcerative colitis,” said Michael Corbo, PhD, Chief Development
Officer, Inflammation & Immunology, Pfizer Inc. “We know there
is a significant unmet need in the UC community for additional
treatment options and, if approved, tofacitinib may have the
potential to offer patients and their physicians an oral treatment
option that could address these unmet needs in the course of the
disease.”
Tofacitinib is the first in a new class of medicines called
Janus kinase (JAK) inhibitors under investigation for the treatment
of moderate to severe UC. Tofacitinib is a small molecule taken as
a pill. It acts on specific inflammatory responses thought to play
a role in the inflammation associated with UC.
Tofacitinib data at UEG Week 2016 includes the following
presentations:
Oral Presentation
1. Tofacitinib has induction efficacy in moderately to severely
active ulcerative colitis, regardless of prior TNF inhibitor
therapy (#OP106, Session: 504 – Future drugs in IBD, Monday,
October 17, 15:45 – 17:15, Room C)
Poster Presentations
2. Tofacitinib for induction therapy in patients with active
ulcerative colitis in two phase 3 clinical trials: results by local
and central endoscopic assessments (#P0306, Poster Session: IBD I,
Monday, October 17, 10:30 – 17:00, Poster Exhibition – Hall X4
& X5)
3. Onset of efficacy of tofacitinib for induction therapy in
patients with active ulcerative colitis in two multinational, phase
3 clinical trials (#P0842, Poster Session: IBD II Tuesday, October
18, 09:00 – 17:00, Poster Exhibition – HALL X4 & X5)
About Ulcerative Colitis
UC is a chronic, often debilitating inflammatory bowel disease
that affects millions of people worldwide.a,b It is believed that
UC is the result of complex interactions between multiple factors
that include the environment, genetic predisposition, immune
response, and the gut microbiome in the colon or intestines.c It
can cause abdominal pain, fever, weight loss and chronic, bloody
diarrhea.d UC can have a significant effect on work, family and
social activities.e In up to one-third of patients with UC,
treatment is not completely successful or complications may arise.f
Under these circumstances, surgery to remove the colon (colectomy)
may be considered.g,h Even after surgery, certain symptoms of UC
may still persist.i
About the OCTAVE Clinical Development Program
The OCTAVE global clinical development program includes three
Phase 3 studies, OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE
Sustain, as well as a long-term extension trial, OCTAVE Open. These
four pivotal studies will form the core of a submission package to
regulatory authorities for a potential UC indication.
OCTAVE Induction 1 and OCTAVE Induction 2 are two replicate
Phase 3 placebo-controlled studies that evaluated induction of
remission by oral tofacitinib 10 mg twice daily (BID) in adult
patients with moderate to severe UC. Subjects must have failed or
been intolerant to at least one prior UC treatment, including
corticosteroids, thiopurines or TNFi. Positive results from OCTAVE
Induction 1 and OCTAVE Induction 2 were presented at the Congress
of European Crohn’s and Colitis Organisation (ECCO) in March
2016.
OCTAVE Sustain is a Phase 3 placebo-controlled study that
evaluated oral tofacitinib 5 mg and 10 mg BID as maintenance
therapy in adult patients with moderately to severely active UC.
Positive topline results were announced in July 2016.
OCTAVE Open is an ongoing open-label extension study designed to
assess the safety and tolerability of tofacitinib 5 mg and 10 mg
BID in patients who have completed or who have had treatment
failure in OCTAVE Sustain or who were non-responders upon
completing OCTAVE Induction 1 or 2.
References available upon request
About XELJANZ (tofacitinib citrate) and XELJANZ XR
(tofacitinib citrate) extended-release
XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a prescription
medicine called a Janus kinase (JAK) inhibitor. In the United
States, XELJANZ XR 11 mg QD is the first and only once-daily oral
JAK inhibitor approved for the treatment of moderate to severe
rheumatoid arthritis (RA) after intolerance or inadequate response
to methotrexate.
As the developer of XELJANZ/XELJANZ XR, Pfizer is a leader in
JAK innovation. XELJANZ is approved in 50 countries around the
world for the treatment of moderate to severe RA as a second-line
therapy after failure of one or more disease-modifying
antirheumatic drugs (DMARDs).
Pfizer is committed to advancing the science of JAK inhibition
and enhancing understanding of XELJANZ through a robust clinical
development program. The efficacy and safety profile of XELJANZ has
been studied in approximately 6,300 patients with moderate to
severe RA, amounting to more than 21,900 patient-years of drug
exposure in the global clinical development program.
XELJANZ is not approved for use by the European Medicines Agency
(EMA). A marketing authorization application for XELJANZ 5 mg BID
is currently under review by the EMA for the treatment of patients
with moderate to severe RA who have had an inadequate response or
intolerance to methotrexate.
XELJANZ is being investigated for the treatment of moderate to
severe UC and is not approved for this indication.
References available upon request
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 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
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well as many of the world's best-known consumer healthcare
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DISCLOSURE NOTICE: The information contained in this
release is as of October 15, 2016. 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 a
potential new indication for XELJANZ for the treatment of adult
patients with moderate to severe UC (the “potential indication”),
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, the
uncertainties inherent in research and development, including 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; whether and when any applications for the potential
indication may be filed with regulatory authorities in any
jurisdictions; whether and when regulatory authorities in any
jurisdictions may approve such applications and/or any other
applications that are pending (including the marketing
authorization application currently under review by the EMA for the
treatment of patients with moderate to severe RA who have had an
inadequate response or intolerance to methotrexate) 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 and XELJANZ XR, including the potential indication; 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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Incidence, Prevalence, and Environmental Influences.
Gastroenterology. 2004;126:1504–1517.
2 Kappelman MD, et al. Recent Trends in the Prevalence of
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https://www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2013/item/p180-impact-of-ulcerative-colitis-on-patient-quality-of-life-in-a-real-world-clinical-setting.html.
[p1/results/ln7-9].
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Drug Design, Development and Therapy. 2011. Available at:
http://www.researchgate.net/publication/51107773. Accessed August
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7 Landy J, Hart AL. Commentary: short-term efficacy of
tacrolimus in steroid-refractory ulcerative colitis. Alimentary
Pharmacology Therapeutics. 2013 Feb. Available at:
http://www.ncbi.nlm.nih.gov/pubmed/23336680. Accessed August 8,
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8 Travis SP, Farrant JM, et al. Predicting outcome in severe
ulcerative colitis. Gut. 1996. Available at:
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[P909/Col1/Par4/Ln 1-4].
9 Crohn’s and Colitis Foundation of America. Surgery for Crohn's
Disease & Ulcerative Colitis. Potential long-term
complications. Available at:
http://www.ccfa.org/resources/surgery-for-crohns-uc.html?referrer=https://www.google.com/.
Accessed September 7, 2016.
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