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Pfizer to present results of phase 3 studies for Xeljanz in rheumatologic diseases at 2016 ACR/ARHP annual meeting
New York | Tuesday, November 8, 2016, 17:00 Hrs  [IST]

Pfizer Inc. announced that 20 abstracts for Xeljanz (tofacitinib citrate) will be presented at the upcoming 2016 ACR/ARHP Annual Meeting (November 11-16, Washington, DC). Notably, results from the two pivotal phase 3 OPAL (Oral Psoriatic Arthritis TriaL) studies of tofacitinib – the only Janus kinase (JAK) inhibitor under investigation for psoriatic arthritis (PsA) – will be presented for the first time. OPAL Broaden will be highlighted during a plenary session and OPAL Beyond will be presented during a late-breaking abstract poster session. In addition, new and updated research for Xeljanz in rheumatoid arthritis (RA) will be presented.

“As part of our commitment to inflammation and immunology, we continue to advance our leading science in the research of Janus kinase inhibition,” said Michael Corbo, chief development officer, inflammation & immunology, Pfizer Global Product Development. “The extensive data being presented at this year's ACR/AHRP annual meeting expands upon our knowledge about the role of Xeljanz for the treatment of moderate to severe rheumatoid arthritis and also highlights its potential, if approved, for the treatment of psoriatic arthritis.”

The RA presentations at this year’s meeting include new research on the benefit: risk profile of Xeljanz as monotherapy; efficacy and safety analyses of Xeljanz with or without concomitant use of glucocorticoids; investigation in the treatment of early RA; and information on time to response. Data being presented at ACR on the efficacy and safety of long-term Xeljanz therapy include real-world experience from an interim analysis of an RA registry and updated information from a long-term extension study up to eight years.

Xeljanz/Xeljanz XR (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. In the United States, Xeljanz XR 11 mg QD is the first and only once-daily oral JAK inhibitor approved for the treatment of moderate to severe rheumatoid arthritis (RA) after intolerance or inadequate response to methotrexate.

As the developer of Xeljanz/Xeljanz XR, Pfizer is a leader in JAK innovation. Xeljanz is approved in 50 countries around the world for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).

Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of Xeljanz through a robust clinical development program. The efficacy and safety profile of Xeljanz has been studied in approximately 6,300 patients with moderate to severe RA, amounting to more than 21,000 patient-years of drug exposure in the global clinical development program.

Xeljanz (tofacitinib citrate)/Xeljanz XR (tofacitinib citrate) extended-release is a prescription medicine called a Janus kinase (JAK) inhibitor. Xeljanz/Xeljanz XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. Xeljanz/Xeljanz XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of Xeljanz/Xeljanz XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine is not recommended.

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