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Pfizer Announces Data For Investigational Compound Tofacitinib In Rheumatoid Arthritis To Be Presented At The American College Of Rheumatology 2012 Annual Meeting

Additional Tofacitinib Efficacy and Safety Data, including Inhibition of Structural Damage, Remission Rates, Patient-Reported Outcomes and Dosing to be Presented

The following data will also be presented:

Radiographic Analyses
  • A sensitivity analysis of ORAL Scan: “Trimmed Analysis: A New Approach to the Analysis of Sharp Score Data in the Assessment of the Progression of Patients with Rheumatoid Arthritis” [Abstract #26935; Monday, November 12, 2012]
  • A post-hoc analysis of radiographic progression in RA patients prone to develop structural damage: “Tofacitinib Inhibits Radiographic Progression in Patients with Rheumatoid Arthritis Prone to Develop Structural Damage: A Post-Hoc Analysis of a Phase 3 Trial” [Abstract #26976; Tuesday, November 13, 2012 at 4:45 p.m. EST]

Additional Efficacy Data
  • Prediction of low disease activity: “Tofacitinib And Adalimumab Achieve Similar Rates Of Low Disease Activity In Rheumatoid Arthritis — Lack Of Improvement In Disease Activity Score By 3 Months Predicts Low Likelihood Of Low Disease Activity At 1 Year” (NCT00853385) [Abstract #28067; Monday, November 12, 2012]
  • Remission rates: “Remission Rates With Tofacitinib Treatment In Rheumatoid Arthritis: A Comparison Of Various Remission Criteria” [Abstract #27787; Sunday, November 11, 2012 at 3:00 p.m. EST]
  • Patient-reported outcomes in ORAL Step and ORAL Scan: “Effects of Tofacitinib On Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis Receiving Stable-Dose Methotrexate” (NCT00960440 and NCT00847613) [Abstract #27211; Monday, November 12, 2012]

  • Dose-related safety and efficacy: “Tofacitinib, An Oral Janus Kinase Inhibitor: Analyses Of Efficacy And Safety Of 10 Versus 5mg Twice Daily In A Pooled Phase 3 And Long-Term Extension Rheumatoid Arthritis Population” [Abstract #26731; Tuesday, November 13 at 2:30 p.m. EST]

Additional Safety Data
  • Effects on cholesterol: “Effects Of Tofacitinib On Lipid Profiles And Cholesterol And Lipoprotein Kinetics In Patients With Rheumatoid Arthritis” [Abstract #27669; Monday, November 12, 2012]
  • ORAL Sequel vaccine sub-study: “Evaluation Of Influenza And Pneumococcal Vaccine Responses In Patients With Rheumatoid Arthritis Receiving Tofacitinib” (NCT00413699) [Abstract #27391; Monday, November 12, 2012]
  • Tuberculosis screening: “Tuberculosis And Tofacitinib Therapy In Patients With Rheumatoid Arthritis” [Abstract #26735, Monday, November 12, 2012]
  • Herpes zoster logistic regression analysis: “Herpes Zoster And Tofacitinib Therapy In Patients With Rheumatoid Arthritis” [Abstract #26957; Tuesday, November 13 at 3:45 p.m. EST]
  • Meta-analysis of certain side effects: “Meta-Analysis Of Malignancies, Serious Infections, And Serious Adverse Events With Tofacitinib Or Biologic Treatment In Rheumatoid Arthritis Clinical Trials” [Abstract #27741; Monday, November 12, 2012 at 5:15 p.m. EST]

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 affects approximately 1.6 million Americans 3,4 and 23.7 million people worldwide. 5 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 DMARD within five years. 6,7,8,9,10,11 There remains a need for additional options.

About Tofacitinib

Tofacitinib is a novel, oral JAK inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA. Unlike recent therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, tofacitinib takes a novel approach targeting the intracellular pathways that operate as hubs in the inflammatory cytokine network.

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