Pfizer announces data for XELJANZ® (tofacitinib citrate) in rheumatoid arthritis

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).