Pfizer Inc. announced today that over 10 abstracts have been accepted for presentation at the European League Against Rheumatism (EULAR) 2014 Annual Meeting (June 11-14, Paris, France), seven of which are focused on further characterizing the safety profile of XELJANZ (tofacitinib citrate) in treating moderately to severely active rheumatoid arthritis. Notably, an abstract titled, “Integrated safety analysis of tofacitinib in rheumatoid arthritis clinical trials with a cumulative exposure of 12,664 patient-years,” will be presented as an oral abstract session (OP0154) on June 13, 2014 at 11:30 a.m. CEST. This analysis describes safety data for XELJANZ in patients from the integrated rheumatoid arthritis clinical trial database, which is based on cumulative exposure in Phase 2, Phase 3, and open-label long-term extension studies. The analysis includes 5,671 patients with a median exposure of 2.4 years including more than 500 patients followed for greater than four years.
“Pfizer is proud to showcase our commitment to the ongoing study of XELJANZ, with a focus on further establishing its benefit:risk profile in rheumatoid arthritis, a disease which affects more than 23 million people worldwide,” said Dr. Steven Romano, Global Medicines Development Lead for the Pfizer Global Innovative Pharmaceutical business.
XELJANZ is now approved in more than 20 countries for the treatment of patients with moderately to severely active rheumatoid arthritis who had an inadequate response to existing therapies. Most recently, Health Canada approved XELJANZ 5 mg twice daily in combination with methotrexate for reducing the signs and symptoms of rheumatoid arthritis in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In cases of intolerance to methotrexate, physicians may consider the use of XELJANZ as monotherapy. Regulatory applications for XELJANZ for the treatment of moderately to severely active rheumatoid arthritis remain under review in more than 35 additional countries. In Europe, XELJANZ is approved in Russia, Switzerland and Turkey, and Pfizer is working on next steps to re-file an application with the European Medicines Agency (EMA).
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