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

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

NEW YORK--(BUSINESS WIRE)-- 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
Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Rheumatoid Arthritis: Open Label, Long-Term Extension Safety and Efficacy Up To 5 Years  

Data from a pooled analysis of two open-label LTE studies (global A3921024 ORAL Sequel Study and Japan A3921041 Study) involving patients with moderately to severely active RA who had participated in randomized Phase 2 or 3 studies of XELJANZ dosed at 5 or 10 mg BID.

  • Analysis showed a consistent safety profile and sustained efficacy for XELJANZ over time up to five years in LTE.
  • Primary endpoints were adverse events and confirmed laboratory safety data.
 

Poster

Abstract #: 33993

 

Date: October 29, 2013

Post-Hoc Analysis Of Risk Factors for Serious Infection Events (SIE)
Post-Hoc Analysis Of Serious Infection Events and Selected Clinical Factors In Rheumatoid Arthritis Patients Treated With Tofacitinib  

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 5 or 10 mg BID were analyzed to determine risk factors for SIEs.

  • Consistent with reports from multiple RA patient databases, analysis identified age (elderly); diabetes; prednisone and 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.
  Poster

Abstract #: 34301

 

Date: October 27, 2013

Integrated Safety Analysis Of Malignancies
Tofacitinib, An Oral Janus Kinase Inhibitor: Analysis Of Malignancies Across The Rheumatoid Arthritis Clinical Program  

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 5 or 10 mg BID were analyzed with regards to malignancies.

  • Analysis showed that the malignancies that occurred are consistent with the type and distribution of 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.
 

Oral presentation

Abstract #: 34063

 

Date: October 27, 2013

Safety and Efficacy of XELJANZ in U.S. Versus ROW Study Populations
Efficacy and Safety Analyses Of Tofacitinib From Pooled Phase 2, Phase 3 and Long-Term Extension Rheumatoid Arthritis Studies: U.S. Compared With Non-U.S. 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 differences in efficacy and/or safety between the U.S. and ROW populations.

  • Analyses showed numerical differences with higher rates for tuberculosis, herpes zoster and lymphoma in ROW 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.
  Poster Abstract #: 34280

 

Date: October 27, 2013

   

Additional XELJANZ Data to be Presented:

         
Title   About

 

Abstract

Details

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

 

Date:

October 27, 2013

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

 

Date:

October 27, 2013

Relationship Between Lymphocyte Count and Risk Of Infection In Rheumatoid Arthritis Patients Treated With Tofacitinib   Relationship between lymphocytes and rates of infection   Poster Abstract #:34133

 

Date:

October 29, 2013

Association Of Mean Changes In Laboratory Safety Parameters With C-Reactive Protein At Baseline and Week 12 In Rheumatoid Arthritis Patients Treated With Tofacitinib   Relationship between laboratory safety parameters and disease activity   Poster Abstract #:34294

 

Date:

October 29,

2013

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

 

Date:

October 27, 2013

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

 

Date:

October 27, 2013

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   Comparison of tofacitinib safety between nonbiologic DMARD-IR and biologic DMARD-IR populations   Poster Abstract #:34132

 

Date:

October 27, 2013

Mechanism of Action    
The Jak Inhibitor Tofacitinib Suppresses Synovial Jak-Stat Signaling In Rheumatoid Arthritis   Synovial biopsy study and inflammatory biomarkers   Oral presentation Abstract #: 35154

 

Date:

October 28,

2013

Health Economics and Outcomes Research    
Effects Of The Oral JAK Inhibitor Tofacitinib In Combination With Methotrexate On Patient Reported Outcomes In a 24-Month Phase 3 Trial Of Active Rheumatoid Arthritis   Patient-reported outcomes at two years in A3921044 ORAL Scan Study   Poster Abstract #:34297

 

Date:

October 29, 2013

Effects Of Tofacitinib, An Oral Janus Kinase Inhibitor, On Work Limitations In Patients With Rheumatoid Arthritis   Work productivity   Poster Abstract #:35376

 

Date:

October 29, 2013

Improvements In Physical Function Correlate With Improvements In Health Related Quality Of Life: Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib: Results From 3 Randomized Phase 3 Trials   Correlation between physical function and improvements in health-related quality of life   Poster Abstract #:34053

 

Date:

October 29, 2013

Sub-population Studies    
Effects Of Smoking Status On Response To Treatment With Tofacitinib In Patients With Rheumatoid Arthritis   Smokers versus non-smokers   Poster Abstract #:34276

 

Date:

October 28, 2013

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

 

Date:

October 29, 2013

Efficacy and Safety Of Tofacitinib In Older and Younger Patients With Rheumatoid Arthritis   Elderly versus non-elderly   Poster Abstract #:34271

 

Date:

October 29, 2013

Post-hoc Analysis    
Remission At 3 Or 6 Months and Radiographic Non-Progression At 12 Months In Methotrexate-Naïve Rheumatoid Arthritis Patients Treated With Tofacitinib Or Methotrexate: A Post-Hoc Analysis Of The ORAL Start Trial   Prediction of response   Poster Abstract #:34274

 

Date:

October 29, 2013

Tofacitinib, An Oral Janus Kinase Inhibitor, In A Rheumatoid Arthritis Open-Label Extension Study Following Adalimumab Therapy In A Phase 3 Randomized Clinical Trial   Switch from adalimumab to tofacitinib   Poster Abstract #:34048

 

Date:

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 Americans1,2 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.



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