Pfizer Announces Data For Investigational Compound Tofacitinib In Rheumatoid Arthritis To Be Presented At The American College Of Rheumatology 2012 Annual Meeting
Pfizer Inc.Media: Victoria DavisO: 484-865-5194E: orInvestor: Jennifer DavisO: 212-733-0717E:
Pfizer Inc. (NYSE: PFE) announced today that 14 abstracts for tofacitinib, an investigational oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA), will be presented at the American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) 2012 Annual Meeting, which is being held November 9-14 in Washington, D.C.
Tofacitinib is currently under review for the treatment of moderate–to-severe active RA by several regulatory agencies around the world, including in the United States, Europe and Japan. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) date of November 21, 2012. If approved, tofacitinib would be the first RA treatment in a new class of medicines known as JAK inhibitors and the first new oral disease-modifying antirheumatic drug (or DMARD) for RA in more than 10 years.
The overall safety profile of tofacitinib was consistent across all aforementioned trials. Notable safety findings observed in the tofacitinib RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; and lipid elevations. The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, nasopharyngitis and diarrhea.
The following data will also be presented:
Radiographic Analyses
Additional Efficacy Data
Dosing
Additional Safety Data
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 Americansand 23.7 million people worldwide. 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. There remains a need for additional options.
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.
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at .
van der Heijde, D. et al. Arthritis Rheum 2011; 63 (Suppl 10): S1017-1018.
Pfizer. (2011). Pfizer Announces Detailed Pivotal Data for Investigational Compound Tofacitinib in Rheumatoid Arthritis to be Presented at American College of Rheumatology 2011 Annual Scientific Meeting [Press release]. Available at .
Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis and Other Rheumatic Conditions in the Ambulatory Health Care System in the United States 2001-2005. . 2010. 62(4): 460-464
Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S. Census Bureau,
World Health Organization, “The Global Burden of Disease, 2004 Update.” Accessed 13 March 2012. Available at .
Klareskog L, Van der Heijde D, de Jager J, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomized controlled trial. 2004. 363: 675-681
Keystone, E, Kavanaugh A, Sharp J, et al. Radiographic, clinical and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy. 2004. 50: 1400-1411
Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in the treatment of rheumatoid arthritis. 2000. 1594-1602.
Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor necrosis factor blockers in daily practice in 770 rheumatic patients. J Rheumatol 2006; 33:2433-8.
Maradit-Kremers H, Nicola PJ, Crowson CS, et al. Patient, disease, and therapy-related factors that influence discontinuation of disease-modifying antirheumatic drugs: a population-based incidence cohort of patients with rheumatoid arthritis. J Rheumatol 2006; 33(2):248-55.
Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and adherence to biologics for rheumatoid arthritis: a systematic review. Clin Ther 2011;33(7):901-913.