Pfizer Announces 11 Abstracts for Tofacitinib to Be Presented at the European League Against Rheumatism (EULAR) 2013 Annual

  Pfizer Announces 11 Abstracts for Tofacitinib to Be Presented at the
  European League Against Rheumatism (EULAR) 2013 Annual Meeting

  Additional Analyses Further Evaluate Safety and Efficacy of Tofacitinib in
                             Rheumatoid Arthritis

Business Wire

NEW YORK -- May 13, 2013

Pfizer Inc. (NYSE: PFE) announced today that 11 abstracts for tofacitinib will
be presented at the European League Against Rheumatism (EULAR) 2013 Annual
Meeting being held June 12-15 in Madrid, Spain. The brand name for tofacitinib

Highlights include:

Comparison of monotherapy vs. combination therapy with tofacitinib

  *A meta-analysis of four Phase 3 trials (ORAL Sync, Standard, Scan and
    Solo) assessed whether there were relative differences in efficacy or
    safety between mono- and combination therapy with tofacitinib in patients
    with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate
    response (IR) to disease-modifying antirheumatic drugs (DMARDs). The
    results showed no statistically significant differences in efficacy or
    safety whether tofacitinib was administered as monotherapy or in
    combination with nonbiologic DMARDs in DMARD-IR patients. Definitive
    conclusions about the relative differences cannot be made based on this
    meta-analysis and would require a randomized clinical trial directly
    comparing mono- and combination therapy. “Tofacitinib, an Oral Janus
    Kinase Inhibitor: Post-Hoc Analyses of Efficacy and Safety of Monotherapy
    Versus Combination Therapy in a Phase 3 Rheumatoid Arthritis Population”
    [Abstract #0228; Thursday, June 13, 2013].

Patient-reported outcome (PRO) results from Phase 3 ORAL Start study

  *Results from a 12-month interim analysis of patient-reported outcomes from
    the 24-month Phase 3 ORAL Start study (A3921069) in methotrexate
    (MTX)-naïve patients with moderate-to-severe RA showed significant
    improvements in patient-reported outcomes, including pain, physical
    function and fatigue, in patients who received tofacitinib 5 mg or 10 mg
    twice daily (BID) monotherapy compared to MTX. In addition, a significant
    improvement in health-related quality of life was also seen in the 10 mg
    BID group versus MTX. “Oral START: Effects of the Oral JAK Inhibitor
    Tofacitinib Monotherapy Versus Methotrexate On Patient Reported Outcomes
    in The Phase 3 Oral START Trial of Active Rheumatoid Arthritis” [Abstract
    #0258; Thursday, June 13, 2013].

An analysis of cardiovascular (CV) biomarkers from Phase 2 and 3 studies

  *An analysis of three Phase 2 and 3 studies of tofacitinib explored changes
    in biomarkers relevant to lipid biochemistry and cardiovascular (CV) risk
    in moderate-to-severe RA patients treated with tofacitinib or placebo. The
    results showed that tofacitinib induced increases in biomarkers, including
    lecithin-cholesterol acyltransferase (LCAT) and paraoxonase, and decreases
    in biomarkers, including serum amyloid A (SAA) and high-density
    lipoprotein (HDL)-associated SAA, potentially implicating Janus kinase
    (JAK)-dependent pathways in structural and functional modifications of
    lipoprotein particles, thereby suggesting a potential for reduction in CV
    risk in patients treated with tofacitinib. Consequences on vascular
    co-morbidity require further investigation. “Effects of Tofacitinib on
    Lipid Biomarkers in Patients with Active Rheumatoid Arthritis” [Abstract
    #0137; Friday, June 14, 2013].

Analysis of lymphocyte count and risk of infection

  *An analysis of the relationship between lymphocyte counts and the risk of
    infection associated with tofacitinib treatment showed lymphocyte counts
    of less than 0.5 x 1000/mm^3 were infrequent but were associated with an
    increased risk of serious infections. These data help inform appropriate
    lymphocyte monitoring. “Relationship between Lymphocyte Count and Risk of
    Infection in Rheumatoid Arthritis Patients Treated with Tofacitinib”
    [Abstract #0252; Thursday, June 13, 2013].

Additional abstracts accepted for presentation include:

  *A post-hoc analysis from the Phase 3 ORAL Start study evaluating
    tofacitinib efficacy, including inhibition of structural damage, in
    patients with early RA (defined by disease duration of <6 months), versus
    MTX in MTX-naïve patients with moderate-to-severe active RA. “Tofacitinib
    Monotherapy is Effective in Methotrexate-Naïve Patients with Disease
    Duration Less Than 6 Months: A Post-Hoc Analysis of Early Rheumatoid
    Arthritis Subjects in a Phase 3 Trial” [Abstract #0225; Thursday, June 13,
  *Efficacy and safety analysis of moderate-to-severe RA patients
    transitioning directly from adalimumab to tofacitinib in a clinical trial
    setting: “Tofacitinib, An Oral Janus Kinase Inhibitor, in a Rheumatoid
    Arthritis Open-Label Extension Study Following Adalimumab Therapy in a
    Phase 3 Randomized Clinical Trial” [Abstract #0046; Hall 4; Thursday, June
    13, 2013 at 11:20 a.m. CEST/ 5:20 a.m. EST].
  *A network meta-analysis comparing efficacy and safety of tofacitinib
    relative to biologic DMARDs in tumor necrosis factor-IR patients:
    “Tofacitinib Versus Biologic Treatments In Patients With Active Rheumatoid
    Arthritis Who Have Had An Inadequate Response To Tumor Necrosis Factor
    Inhibitors -- A Network Meta-Analysis” [Abstract #0115; Saturday, June 15,
  *Assessment of responses of two standard vaccines in RA patients treated
    with tofacitinib: “Evaluation of Influenza and Pneumococcal Vaccine
    Responses in Rheumatoid Arthritis Patients using tofacitinib” [Abstract
    #0163; Hall 8; Friday, June 14 at 10:50 a.m. CEST/4:50 a.m. EST].
  *Comparison of tofacitinib safety between nonbiologic DMARD-IR and biologic
    DMARD-IR populations: “Tofacitinib, An Oral Janus Kinase Inhibitor: Safety
    Comparison In Patients With Rheumatoid Arthritis And An Inadequate
    Response To Nonbiologic Or Biologic Disease Modifying Anti-Rheumatic
    Drugs” [Abstract #0238; Thursday, June 13, 2013].
  *Assessment of hemoglobin changes and the relationship to patient-reported
    fatigue or vitality: “Hemoglobin Changes And Relationship Between Anemia
    And Fatigue Or Vitality In Rheumatoid Arthritis Patients Treated With
    Tofacitinib” [Abstract #0241; Thursday, June 13, 2013].
  *Human mechanistic Phase 2A study assessing how tofacitinib alters synovial
    biology and inflammatory biomarkers in RA: “The JAK Inhibitor Tofacitinib
    Suppresses Synovial JAK1-STAT1 Signaling in Rheumatoid Arthritis”
    [Abstract #0253; Friday, June 14, 2013 at 10:20 a.m. CEST/4:20 a.m. EST].

Safety findings observed in the overall tofacitinib RA program include serious
and other important infections, including tuberculosis and herpes zoster;
malignancies, including lymphoma; gastrointestinal perforations; decreased
neutrophil and lymphocyte counts; liver enzyme elevations; and lipid

The most common serious adverse events were serious infections. The most
commonly reported adverse events were upper respiratory tract infections,
headache, diarrhea and nasopharyngitis.

About Rheumatoid Arthritis

Rheumatoid arthritis 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 can be painful and disabling^1 causing swelling,
stiffness and loss of function in the joints.^1 RA affects 23.7 million people
worldwide.^2 Although multiple treatments are available, up to one-third of
patients do not adequately respond, and about half stop responding to any
particular DMARD within five years.^3,4,5,6,7,8 As a result, there remains a
need for additional options.

About XELJANZ (tofacitinib citrate)

XELJANZ is a novel, oral Janus kinase (JAK) inhibitor for the treatment of RA.
XELJANZ is approved in the United States, Japan and Russia for the treatment
of adults with moderate-to-severe active RA with previous treatment history,
and is the first approved RA treatment in a new class of medicines known as
Janus kinase (JAK) inhibitors.

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 health care products. Our global portfolio includes medicines
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who rely on us. To learn more, please visit us at

DISCLOSURE NOTICE: The information contained in this release is as of May 13,
2013. Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future events or

This release contains forward-looking information that involves substantial
risks and uncertainties about tofacitinib, including its potential benefits
and risks as well as clinical trial data relating to tofacitinib and the
potential implications of such data. Such risks and uncertainties include,
among other things, the uncertainties inherent in research and development,
including the possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing clinical
data, and the need for additional clinical studies to confirm certain results
discussed in this release; whether and when regulatory authorities in
jurisdictions in which applications for tofacitinib for the treatment of
moderate-to-severe rheumatoid arthritis are pending or will be submitted will
approve such applications as well as their decisions regarding labeling and
other matters that could affect its availability or commercial potential; and
competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s
Annual Report on Form 10-K/A for the fiscal year ended December 31, 2012 and
in its reports on Form 10-Q and Form 8-K.

^1 Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903–911.

^2 World Health Organization, “The Global Burden of Disease, 2004 Update.” Accessed
13 March 2012. Available at

^3 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

^4 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: 1400-1411

^5 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.

^6 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;

^7 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.

^8 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and
adherence to biologics for rheumatoid arthritis: a systematic review. Clin Ther


Pfizer Inc.
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