Pfizer to Present Additional Research For XELJANZ® (Tofacitinib Citrate) In Rheumatologic Diseases, Including Rheumatoid Arthritis and Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) announced today that 20 abstracts for XELJANZ^®
(tofacitinib citrate) will be presented at the upcoming 2016 ACR/ARHP
Annual Meeting (November 11-16, Washington, DC). Notably, results from
the two pivotal Phase 3 OPAL (Oral Psoriatic Arthritis
TriaL) studies of tofacitinib – the only Janus kinase (JAK)
inhibitor under investigation for psoriatic arthritis (PsA) – will be
presented for the first time. OPAL Broaden will be highlighted during a
plenary session and OPAL Beyond will be presented during a late-breaking
abstract poster session. In addition, new and updated research for
XELJANZ in rheumatoid arthritis (RA) will be presented.

“As part of our commitment to inflammation and immunology, we continue
to advance our leading science in the research of Janus kinase
inhibition,” said Michael Corbo, Chief Development Officer, Inflammation
& Immunology, Pfizer Global Product Development. “The extensive data
being presented at this year’s ACR/AHRP annual meeting expands upon our
knowledge about the role of XELJANZ for the treatment of moderate to
severe rheumatoid arthritis and also highlights its potential, if
approved, for the treatment of psoriatic arthritis.”

The RA presentations at this year’s meeting include new research on the
benefit:risk profile of XELJANZ as monotherapy; efficacy and safety
analyses of XELJANZ with or without concomitant use of glucocorticoids;
investigation in the treatment of early RA; and information on time to
response. Data being presented at ACR on the efficacy and safety of
long-term XELJANZ therapy include real-world experience from an interim
analysis of an RA registry and updated information from a long-term
extension study up to eight years.

Pfizer-sponsored research at the 2016 ACR/ARHP Annual Meeting includes
the following presentations:

XELJANZ RA

Oral Presentations

• Major Adverse Cardiovascular Events: Risk Factors in Patients with RA
  Treated with Tofacitinib [#3024, Session: Rheumatoid Arthritis – Small
  Molecules, Biologics and Gene Therapy III: Small Molecules and Early
  Intervention, Nov. 15, 2016, 2:30-4p.m.]
• Inflammation Detected with Modern Sensitive MRI Analysis Demonstrates
  that Therapeutic Response as Early as One Month Predicts 12-Month
  Radiographic Progression: Data from a Study Using Tofacitinib and
  Methotrexate in Early RA [#3090, Session: Rheumatoid Arthritis – Small
  Molecules, Biologics and Gene Therapy IV: Biomarkers, Nov. 15, 2016,
  4:30-6p.m.]

Poster Presentations

• Magnitude and Duration of Early Response with Tofacitinib: Post-Hoc
  Analysis of Two Phase 3, Placebo-Controlled Studies [#1595, Session:
  Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy –
  Poster II, Nov. 14, 2016, 9-11a.m.]
• Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in
  Open-Label, Long-Term Extension Studies up to 8 Years [#1602, Session:
  Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy –
  Poster II, Nov. 14, 2016, 9-11a.m.]
• Efficacy of Tofacitinib in Patients who are Inadequate Responders to
  Disease-Modifying Antirheumatic Drugs According to Early Versus Late
  Duration of Rheumatoid Arthritis: Post-Hoc Analysis of Data from Phase
  3 trials [#1609, Session: Rheumatoid Arthritis – Small Molecules,
  Biologics and Gene Therapy – Poster II, Nov. 14, 2016, 9-11a.m.]
• Tofacitinib: Treatment Outcomes in Seropositive Versus Seronegative
  Patients in a Phase 3 RA Population [#1643, Session: Rheumatoid
  Arthritis – Small Molecules, Biologics and Gene Therapy – Poster II,
  Nov. 14, 2016, 9-11a.m.]
• Discontinuation of Methotrexate or Glucocorticoids in Patients with
  Rheumatoid Arthritis Treated with Tofacitinib: Clinical Efficacy Data
  from Long-Term Extension Studies [#1646, Session: Rheumatoid Arthritis
  – Small Molecules, Biologics and Gene Therapy – Poster II, Nov. 14,
  2016, 9-11a.m.]
• Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of
  Rheumatoid Arthritis: Safety and Efficacy in Open-Label, Long-Term
  Extension Studies over 8 Years [#1647, Session: Rheumatoid Arthritis –
  Small Molecules, Biologics and Gene Therapy – Poster II, Nov. 14,
  2016, 9-11a.m.]
• Long-Term Clinical, Radiographic and Patient-Reported Outcomes Based
  on RAPID3 Responses with Tofacitinib at 6 Months [#1648, Session:
  Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy –
  Poster II, Nov. 14, 2016, 9-11a.m.]
• Evaluation of Disease Activity in Patients with Rheumatoid Arthritis
  Treated with Tofacitinib by RAPID3: An Analysis of Data from 6 Phase 3
  Studies [#1600, Session: Rheumatoid Arthritis – Small Molecules,
  Biologics and Gene Therapy – Poster II, Nov. 14, 2016, 9-11a.m.]
• Lack of Early Change in Disease Activity Score Predicts the Likelihood
  of Achieving Low Disease Activity at Month 6: Tofacitinib Monotherapy
  versus Methotrexate in Methotrexate-Naïve Patients with Rheumatoid
  Arthritis [#1608, Session: Rheumatoid Arthritis – Small Molecules,
  Biologics and Gene Therapy – Poster II, Nov. 14, 2016, 9-11a.m.]
• Real World Results from a Post-Approval Safety Surveillance of
  Tofacitinib (Xeljanz): Over 3 Year Results from an Ongoing US-Based
  Rheumatoid Arthritis Registry [#2595, Session: Rheumatoid Arthritis –
  Small Molecules, Biologics and Gene Therapy – Poster III, Nov. 15,
  2016, 9-11a.m.]
• Effect of Glucocorticoids on Clinical and Radiographic Efficacy
  Outcomes in Methotrexate-Naïve Patients with RA Receiving Tofacitinib
  or Methotrexate Monotherapy: Analysis of Data from a Phase 3 Trial
  [#2606, Session: Rheumatoid Arthritis – Small Molecules, Biologics and
  Gene Therapy – Poster III, Nov. 15, 2016, 9-11a.m.]
• The Effectiveness of Zoster Vaccine in RA Patients Subsequently
  Treated up to 19 Months with Tofacitinib [#2609, Session: Rheumatoid
  Arthritis – Small Molecules, Biologics and Gene Therapy – Poster III,
  Nov. 15, 2016, 9-11a.m.]

XELJANZ Investigational Research Areas

Oral Presentations

• Treatment with Tofacitinib is Associated with Clinically Meaningful
  Reductions in Axial MRI Inflammation in Patients with Ankylosing
  Spondylitis [#1044, Session: Spondylarthropathies and Psoriatic
  Arthritis – Clinical Aspects and Treatment II: Axial Spondyloarthritis
  – Treatment, Nov. 13, 2016, 4:30-6p.m.]
• Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, or
  Adalimumab in Patients With Active Psoriatic Arthritis and An
  Inadequate Response to Conventional Synthetic DMARDs: A Randomized,
  Placebo controlled, Phase 3 Trial [#2983, Session: Plenary Session
  III: Discovery 2016, Nov. 15, 2016, 11a.m.-12:30p.m.]

Poster Presentations

• Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in
  Patients with Active Psoriatic Arthritis and an Inadequate Response to
  Tumor Necrosis Factor Inhibitors: OPAL Beyond, a Randomized, Double
  Blind, Placebo-Controlled, Phase 3 Trial [#10L, Late-breaking Abstract
  Poster Session, Nov. 13, 2016, 9-11a.m.]
• Pharmacokinetics, safety, and tolerability of tofacitinib in pediatric
  patients from two to less than eighteen years of age with juvenile
  idiopathic arthritis [#388, Session: Pediatric Rheumatology – Clinical
  and Therapeutic Aspects – Poster I: Juvenile Idiopathic Arthritis,
  Uveitis, Nov. 13, 2016, 9-11a.m.]

Additional Pfizer-Sponsored Abstracts

Poster Presentations

• Understanding the Importance of a Patient’s Role in the Management of
  RA: Physician- and Patient-Based Survey [#81, Session: Health Services
  Research – Poster I, Nov. 13, 2016, 9-11a.m.]
• Treatment Patterns, Unmet Need, and Impact of Psoriatic Arthritis on
  Patient-Reported Outcomes in the United States [#2729, Session:
  Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and
  Treatment – Poster III, Nov. 15, 2016, 9-11a.m.]

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 21,000 patient-years of drug exposure in the global clinical
development program.

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.

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,
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DISCLOSURE NOTICE: The information contained in this release is as of
November 7, 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 XELJANZ
(tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) extended-release,
including a potential new indication for XELJANZ for the treatment of
psoriatic arthritis and their 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, 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; whether and when any
applications for the potential new 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 European
Medicines Agency 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/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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