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 Presented 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 studied. *Conclusions are limited by the difference in population sizes. Additional XELJANZ Data to be Presented: Abstract Title About Details 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 #:34133 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 #:34294 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, 2013 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: Arthritis October 28, 2013 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 #:35376 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 #:34276 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 #:34271 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 habits. *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). About XELJANZ 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. 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 and vaccines as well as many of the world's best-known consumer health care 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. To learn more, please visit us at www.pfizer.com. ^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 http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. ^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: 1400-1411 ^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. Contact: Pfizer Inc. Media Contact: Kim Bencker M: 610-329-1340 E: Kim.Bencker@pfizer.com or Investor Contact: Suzanne Harnett O: 212-733-8009 E: Suzanne.Harnett@pfizer.com
Pfizer Announces Data For XELJANZ® (tofacitinib citrate) In Rheumatoid Arthritis To Be Presented At The American College Of
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