Pfizer Announces Data For XELJANZ® (tofacitinib citrate) In Rheumatoid Arthritis To Be Presented At The American College Of

  Pfizer Announces Data For XELJANZ® (tofacitinib citrate) In Rheumatoid
  Arthritis To Be Presented At The American College Of Rheumatology 2013
  Annual Meeting

    Long-Term Safety and Efficacy Data of XELJANZ Up to Five Years Will Be

2013 ACR/ARHP Annual Meeting

Business Wire

NEW YORK -- September 24, 2013

Pfizer Inc. (NYSE:PFE) announced today that 20 abstracts for XELJANZ^®
(tofacitinib citrate), the first in a new class for the treatment of
rheumatoid arthritis (RA), oral Janus kinase (JAK) inhibitors, will be
presented at the American College of Rheumatology (ACR) / Association of
Rheumatology Health Professionals (ARHP) 2013 Annual Meeting, which is being
held October 25-30 in San Diego, CA. XELJANZ is approved in the United States
for the treatment of adults with moderately to severely active RA who have had
an inadequate response or intolerance to methotrexate, at a dose of 5 mg
tablet twice daily.

These data add to the understanding of the efficacy and safety profile of
XELJANZ in the treatment of RA. XELJANZ was studied in a comprehensive,
global, multi-study program that included approximately 5,000 patients across
Phase 2 and 3 trials in more than 40 countries, resulting in 7,000
patient-years of exposure through 2011, the time of regulatory submission.
These data further inform rheumatologists who are prescribing or considering
prescribing XELJANZ for appropriate patients.

Among the analyses being presented are open-label safety and efficacy data up
to five years in long-term extension (LTE) studies; integrated and post-hoc
analyses of safety data; and post-hoc safety and efficacy analyses of clinical
trial sub-populations, notably one that analyzed the safety profile and
efficacy of XELJANZ in U.S. patients versus patients from the Rest of World
(ROW). More details on these abstracts are found below.

Title                   About                              Abstract Details
LTE Safety and Efficacy Data Up to Five Years
                         Data from a pooled analysis of
                         two open-label LTE studies
                         (global A3921024 ORAL Sequel
                         Study and Japan A3921041 Study)
                         involving patients with
Tofacitinib, an Oral     moderately to severely active RA    Poster
Janus Kinase             who had participated in
Inhibitor, in the        randomized Phase 2 or 3 studies     Abstract #: 33993
Treatment of            of XELJANZ dosed at 5 or 10 mg    
Rheumatoid Arthritis:    BID.                                
Open Label, Long-Term
Extension Safety and       *Analysis showed a consistent    Date: October 29,
Efficacy Up To 5 Years       safety profile and sustained    2013
                             efficacy for XELJANZ over
                             time up to five years in LTE.
                           *Primary endpoints were
                             adverse events and confirmed
                             laboratory safety data.
Post-Hoc Analysis Of Risk Factors for Serious Infection Events (SIE)
                         Data from a pooled analysis of
                         five randomized Phase 2 studies,
                         five randomized Phase 3 studies
                         and two open-label LTE studies
                         involving patients with
                         moderately to severely active RA
                         who had received XELJANZ dosed at
Post-Hoc Analysis Of     5 or 10 mg BID were analyzed to     Poster
Serious Infection        determine risk factors for SIEs.
Events and Selected                                          Abstract #: 34301
Clinical Factors In       *Consistent with reports from  
Rheumatoid Arthritis         multiple RA patient             
Patients Treated With        databases, analysis
Tofacitinib                  identified age (elderly);       Date: October 27,
                             diabetes; prednisone and        2013
                             corticosteroid equivalent
                             dose ≥7.5 mg as independent
                             factors associated with an
                             increased risk of SIEs.
                           *Tofacitinib dose was also
                             identified as an independent
                             risk factor for SIEs.
Integrated Safety Analysis Of Malignancies
                         Data from a pooled analysis of
                         six randomized Phase 2 studies,
                         six randomized Phase 3 studies
                         and two open-label LTE studies
                         involving patients with
                         moderately to severely active RA
                         who had received XELJANZ dosed at   Oral presentation
Tofacitinib, An Oral     5 or 10 mg BID were analyzed with
Janus Kinase             regards to malignancies.            Abstract #: 34063
Inhibitor: Analysis Of
Malignancies Across       *Analysis showed that the       
The Rheumatoid               malignancies that occurred
Arthritis Clinical           are consistent with the type    Date: October 27,
Program                      and distribution of             2013
                             malignancies expected for
                             patients with moderately to
                             severely active RA and rates
                             are consistent with published
                             estimates in RA patients
                             treated with biologic and
                             non-biologic DMARDs.
Safety and Efficacy of XELJANZ in U.S. Versus ROW Study Populations
                         Pooled data from DMARD-inadequate
                         responder patients with
                         moderately to severely active RA
                         in six Phase 2 and five Phase 3
                         randomized studies and two
                         open-label LTE studies who
                         received XELJANZ dosed at 5 or 10
                         mg BID were analyzed to determine
                         whether there were any
Efficacy and Safety      differences in efficacy and/or
Analyses Of              safety between the U.S. and ROW     Poster Abstract
Tofacitinib From         populations.                        #: 34280
Pooled Phase 2, Phase
3 and Long-Term           *Analyses showed numerical      
Extension Rheumatoid         differences with higher rates
Arthritis Studies:           for tuberculosis, herpes        Date: October 27,
U.S. Compared With           zoster and lymphoma in ROW      2013
Non-U.S. Populations         compared with the U.S. but
                             higher rates of serious
                             infection events,
                             malignancies and deaths in
                             the U.S.
                           *Efficacy in general was
                             similar between populations
                           *Conclusions are limited by
                             the difference in population

Additional XELJANZ Data to be Presented:

Title                             About                   
Safety Data                                                 
                                                             Poster Abstract
Tofacitinib, An Oral Janus                                   #:34071
Kinase Inhibitor: Analysis Of      Integrated safety
Gastrointestinal Adverse Events   analysis of              
Across The Rheumatoid Arthritis    gastrointestinal
Clinical Program                   adverse events            Date:

                                                             October 27, 2013
                                                             Poster Abstract
Cardiovascular Safety Findings                               #:34076
In Rheumatoid Arthritis Patients   Integrated safety
Treated With Tofacitinib, A       analysis of              
Novel, Oral Janus Kinase           cardiovascular adverse
Inhibitor                          events                    Date:

                                                             October 27, 2013
                                                             Poster Abstract
Relationship Between Lymphocyte    Relationship between
Count and Risk Of Infection In    lymphocytes and rates    
Rheumatoid Arthritis Patients      of infection
Treated With Tofacitinib                                     Date:

                                                             October 29, 2013
                                                             Poster Abstract
Association Of Mean Changes In
Laboratory Safety Parameters       Relationship between      
With C-Reactive Protein At        laboratory safety       
Baseline and Week 12 In            parameters and disease    Date:
Rheumatoid Arthritis Patients      activity
Treated With Tofacitinib                                     October 29,

                                                             Poster Abstract
Reversibility Of Pharmacodynamic                             #:34285
Effects After Short- and
Long-Term Treatment With          Reversibility of the     
Tofacitinib In Patients With       pharmacodynamic effects
Rheumatoid Arthritis                                         Date:

                                                             October 27, 2013
                                                             Poster Abstract
Tolerability and Non-Serious                                 #:34275
Adverse Events In Rheumatoid
Arthritis Patients Treated With   Tolerability             
Tofacitinib As Monotherapy Or In
Combination Therapy                                          Date:

                                                             October 27, 2013
Tofacitinib, An Oral Janus                                   Poster Abstract
Kinase Inhibitor: Safety           Comparison of             #:34132
Comparison In Patients With        tofacitinib safety
Rheumatoid Arthritis and An       between nonbiologic      
Inadequate Response To             DMARD-IR and biologic
Nonbiologic Or Biologic            DMARD-IR populations      Date:
Disease-Modifying Anti-Rheumatic
Drugs                                                        October 27, 2013
Mechanism of Action                                         
                                                             Oral presentation
                                                             Abstract #: 35154

The Jak Inhibitor Tofacitinib      Synovial biopsy study     
Suppresses Synovial Jak-Stat      and inflammatory        
Signaling In Rheumatoid            biomarkers                Date:
                                                             October 28,

Health Economics and Outcomes Research                      
                                                             Poster Abstract
Effects Of The Oral JAK                                      #:34297
Inhibitor Tofacitinib In           Patient-reported
Combination With Methotrexate On  outcomes at two years    
Patient Reported Outcomes In a     in A3921044 ORAL Scan
24-Month Phase 3 Trial Of Active   Study                     Date:
Rheumatoid Arthritis
                                                             October 29, 2013
                                                             Poster Abstract
Effects Of Tofacitinib, An Oral
Janus Kinase Inhibitor, On Work   Work productivity        
Limitations In Patients With
Rheumatoid Arthritis                                         Date:

                                                             October 29, 2013
Improvements In Physical                                     Poster Abstract
Function Correlate With            Correlation between       #:34053
Improvements In Health Related     physical function and
Quality Of Life: Reported         improvements in          
Outcomes In Rheumatoid Arthritis   health-related quality
Patients Treated With              of life                   Date:
Tofacitinib: Results From 3
Randomized Phase 3 Trials                                    October 29, 2013
Sub-population Studies                                      
                                                             Poster Abstract
Effects Of Smoking Status On
Response To Treatment With        Smokers versus           
Tofacitinib In Patients With       non-smokers
Rheumatoid Arthritis                                         Date:

                                                             October 28, 2013
                                                             Poster Abstract
Assessment of Lipid Changes and                              #:34273
Infection Risk In Diabetic and
Nondiabetic Patients With         Diabetic versus          
Rheumatoid Arthritis Treated       nondiabetic patients
With Tofacitinib                                             Date:

                                                             October 29, 2013
                                                             Poster Abstract
Efficacy and Safety Of
Tofacitinib In Older and Younger  Elderly versus           
Patients With Rheumatoid           non-elderly
Arthritis                                                    Date:

                                                             October 29, 2013
Post-hoc Analysis                                           
Remission At 3 Or 6 Months and                               Poster Abstract
Radiographic Non-Progression At                              #:34274
12 Months In Methotrexate-Naïve
Rheumatoid Arthritis Patients     Prediction of response   
Treated With Tofacitinib Or
Methotrexate: A Post-Hoc                                     Date:
Analysis Of The ORAL Start Trial
                                                             October 29, 2013
                                                             Poster Abstract
Tofacitinib, An Oral Janus                                   #:34048
Kinase Inhibitor, In A
Rheumatoid Arthritis Open-Label   Switch from adalimumab   
Extension Study Following          to tofacitinib
Adalimumab Therapy In A Phase 3                              Date:
Randomized Clinical Trial
                                                             October 27, 2013

Important Safety Information

  *XELJANZ can lower the ability of the immune system to fight infections.
    Some people have serious infections while taking XELJANZ, 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, and monitor them closely for signs and symptoms of TB
    and other infections during treatment. People should not start taking
    XELJANZ if they have any kind of infection unless their healthcare
    provider tells them it is okay.
  *XELJANZ may increase the risk of certain cancers by changing the way the
    immune system works. Lymphoma and other cancer can happen in patients
    taking XELJANZ.
  *Some people taking XELJANZ get tears in their stomach or intestines.
    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
  *XELJANZ 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 and while they are taking XELJANZ, to check
    for these side effects. Normal cholesterol levels are important to good
    heart health. Healthcare providers may stop XELJANZ treatment because of
    changes in blood cell counts or liver test results.
  *Patients should tell their healthcare providers if they plan to become
    pregnant or are pregnant.

    It is not known if XELJANZ will harm an unborn baby. To monitor the
    outcomes of pregnant women exposed to XELJANZ, 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 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. Healthcare providers may
    do blood tests for hepatitis before and during treatment with XELJANZ.
  *Common side effects include upper respiratory tract infections (common
    cold, sinus infections), headache, diarrhea, nasal congestion, sore
    throat, and runny nose (nasopharyngitis).


XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor.
XELJANZ is used to treat adults with moderately to severely active rheumatoid
arthritis in which methotrexate did not work well.

  *It is not known if XELJANZ is safe and effective in people with Hepatitis
    B or C.
  *XELJANZ is not for people with severe liver problems.
  *It is not known if XELJANZ is safe and effective in children.

About Rheumatoid Arthritis

RA is a chronic inflammatory autoimmune disease that typically affects the
hands and feet, although any joint lined by a synovial membrane may be
affected. RA affects approximately 1.6 million Americans^1,2 and 23.7 million
people worldwide.^3 Although multiple treatments are available, many patients
do not adequately respond. Specifically, up to one-third of patients do not
adequately respond and about half stop responding to any particular
non-biologic disease-modifying antirheumatic drug (DMARD) within five
years.^4,5,6,7,8,9 There remains a need for additional therapeutic options.

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^1 Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis
and Other Rheumatic Conditions in the Ambulatory Health Care System in the
United States 2001-2005. Arthritis Care and Research. 2010. 62(4): 460-464

^2 Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S. Census
Bureau, 2010 Census Summary File 1

^3 World Health Organization, “The Global Burden of Disease, 2004 Update.”
Accessed 13 March 2012. Available at

^4 Klareskog L, Van der Heijde D, de Jager J, et al. Therapeutic effect of the
combination of etanercept and methotrexate compared with each treatment alone
in patients with rheumatoid arthritis: double-blind randomized controlled
trial. The Lancet 2004. 363: 675-681

^5 Keystone, E, Kavanaugh A, Sharp J, et al. Radiographic, clinical and
functional outcomes of treatment with adalimumab (a human anti-tumor necrosis
factor monoclonal antibody) in patients with active rheumatoid arthritis
receiving concomitant methotrexate therapy. Arthritis & Rheumatism 2004. 50:

^6 Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in
the treatment of rheumatoid arthritis. The New England Journal of Medicine
2000. 1594-1602.

^7 Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor
necrosis factor blockers in daily practice in 770 rheumatic patients. J
Rheumatol 2006; 33:2433-8.

^8 Maradit-Kremers H, Nicola PJ, Crowson CS, et al. Patient, disease, and
therapy-related factors that influence discontinuation of disease-modifying
antirheumatic drugs: a population-based incidence cohort of patients with
rheumatoid arthritis. J Rheumatol 2006; 33(2):248-55.

^9 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and
adherence to biologics for rheumatoid arthritis: a systematic review. Clin
Ther 2011;33(7):901-913.


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