THU0136
CARDIOVASCULAR SAFETY FINDINGS IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB (CP-690,550), A NOVEL, ORAL JAK INHIBITOR
C. Charles-Schoeman 1,*P. Wicker 2U. Sechtem 3M. A. Gonzalez-Gay 4S. Wood 5M. Boy 5J. Geier 6D. Gruben 5K. Soma 5R. Riese 5J. Bradley 5
1University of California, Los Angeles, CA, 2PW Consulting LLC, Mystic, CT, United States, 3Robert-Bosch-Krankenhaus, Stuttgart, Germany, 4Hospital Universitario Marqués de Valdecilla, Santander, Spain, 5Pfizer Inc., Groton, CT, 6Pfizer Inc., New York, NY, United States
Background: Tofacitinib is a novel, oral Janus kinase inhibitor being investigated as a targeted immunomodulator and disease-modifying therapy in rheumatoid arthritis (RA).
Objectives: To evaluate the cardiovascular (CV) event rates and changes in blood pressure (BP) in the tofacitinib Phase 3 (P3) and long-term open-label extension (LTE) studies.
Methods: Five P3 studies in patients (pts) with inadequate response to nonbiologic/biologic disease-modifying anti-rheumatic drugs (DMARDs) and 2 LTE studies were included. Tofacitinib was administered as monotherapy or with background nonbiologic DMARDs, predominantly methotrexate. One P3 study included adalimumab (ADA) as active control. An independent CV Safety Endpoint Adjudication Committee performed blinded adjudication of deaths, potential major adverse CV events (MACE), and events of congestive heart failure (CHF). MACE was defined as CV death and non-fatal CV events.
Results:
Conclusions: Incidence rates of MACE were similar across groups in P3 with lower rates in LTE, suggesting no increased risk over 3 years of follow up. Tofacitinib was not associated with clinically meaningful increases in BP. Although the number of events have been few and longer observation periods are warranted, CV risk does not appear to be increased with tofacitinib treatment and rates of CV events are consistent with those observed among patients with RA of similar disease severity.1-3
References: 1. Solomon DH et al. Circulation 2003; 107: 1303-1307; 2. Solomon DH et al. Ann Rheum Dis 2006; 65: 1608-1612; 3. Nicola PJ et al. Arthritis Rheum 2006; 54: 60-67.
Disclosure of Interest: C. Charles-Schoeman Grant / Research support from: Pfizer Inc. Consultant for: Pfizer Inc.P. Wicker Consultant for: Pfizer Inc.U. Sechtem Consultant for: Pfizer Inc.M. Gonzalez-Gay Consultant for: Pfizer Inc.S. Wood Shareholder of: Pfizer Inc. Employee of: Pfizer Inc.M. Boy Shareholder of: Pfizer Inc. Employee of: Pfizer Inc.J. Geier Shareholder of: Pfizer Inc. Employee of: Pfizer Inc.D. Gruben Shareholder of: Pfizer Inc. Employee of: Pfizer Inc.K. Soma Shareholder of: Pfizer Inc. Employee of: Pfizer Inc.R. Riese Shareholder of: Pfizer Inc. Employee of: Pfizer Inc.J. Bradley Shareholder of: Pfizer Inc. Employee of: Pfizer Inc.