Pfizer announces over 10 abstracts for XELJANZ® (Tofacitinib Citrate) in rheumatoid arthritis to be presented at the European League Against Rheumatism Annual Meeting

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).

The following additional abstracts focused on further characterizing the efficacy and safety profile of XELJANZ have also been accepted for presentation at the EULAR 2014 Annual Meeting:

Safety and Epidemiology

• “Tofacitinib, An Oral Janus Kinase Inhibitor: Analysis Of Malignancies Across The Rheumatoid Arthritis Clinical Programme.” Mariette X, Curtis JR, Lee EB et. al. [THU0147; June 12, 2014 11:45 a.m.; Poster Session]
• “Tofacitinib, An Oral Janus Kinase Inhibitor: Analysis Of Malignancies In Japanese Patients Across The Rheumatoid Arthritis Clinical Programme.” Tanaka Y, Takeuchi T, Yamanaka H et. al. [THU0148; June 12, 2014 11:45 a.m.; Poster Session]
• “Association Of Mean Changes In Laboratory Safety Parameters With C-Reactive Protein At Baseline And Week 12 In Rheumatoid Arthritis Patients Treated With Tofacitinib.” Strand V, Issacs JD, Beal J et. al. [THU0145; June 12, 2014 11:45 a.m.; Poster Session]
• “Evaluation Of The Effect Of Tofacitinib On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis.” Kremer J, Kivitz AJ, Simon-Campos JA et. al. [THU0126; June 13, 2014 11:45 a.m.; Poster Session]
• “Changes In T And B Lymphocyte Subsets With Tofacitinib Do Not Translate From Nonclinical Species To Humans.” Ball D J, Kawabata T, Vogel W M et. al. [AB0474; Abstract Book Only]
• “Contextualisation Of Safety Endpoints In The Tofacitinib Rheumatoid Arthritis (Ra) Development Programme: Collaboration With The Consortium Of Rheumatology Researchers Of North America (CORRONA) Registry.” Geier J, KC Saunders, G Reed G. [AB1057; Abstract Book Only]

Efficacy

• “Effects Of Tofacitinib Monotherapy Versus Methotrexate On Patient-Reported Outcomes In The 2-Year Phase 3 Oral Start Trial In Methotrexate-Naïve Patients With Rheumatoid Arthritis.” Alten RE, Strand V, Fleischmann R et al. [OP0152; June 13, 2014 11:10 a.m.; Oral Presentation].

Once Daily Formulation in Healthy Volunteers

• “Pharmacokinetics, Bioavailability And Safety Of A Modified Release Once Daily Formulation Of Tofacitinib In Healthy Volunteers.” Lamba M, Wang R, Fletcher T et. al. [THU0143; June 12, 2014 11:45 a.m.; Poster Session]
  Health Economics and Outcomes Research
• “Estimated Medical Expenditures Among Patients With Rheumatoid Arthritis Undergoing Treatment With Tofacitinib, An Oral Janus Kinase Inhibitor.” Rendas-Baum R, Kosinski M, Singh A et. al.[FRI0178; June 13, 2014 11:45 a.m.; Poster Session]

Safety findings observed in the overall rheumatoid arthritis program for XELJANZ include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; liver enzyme elevations; and lipid elevations.

The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.