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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

Stocks in this article: PFE

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]

Dosing

  • 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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