Advances body of evidence for tofacitinib citrate (xeljanz®) providing clinicians with additional information for the treatment of moderate to severe ra

News Hour:

Pfizer Inc. (NYSE:PFE) announced that 23 abstracts, including research and analyses for tofacitinib citrate (XELJANZ^®), will be featured at the upcoming European League Against Rheumatism (EULAR) Congress (June 8-11, London). The research being shared at the meeting provides new and additional information on the efficacy and safety profile of tofacitinib citrate, including its use as a single agent without methotrexate.

“The data being presented at the Annual European Congress of Rheumatology (EULAR 2016) provides important information to help guide physicians on treatment approaches for tofacitinib citrate in rheumatoid arthritis (RA),” said Dr. Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and Co-Medical Director, Metroplex Clinical Research Center. “For years, combination therapy has been the standard of care for treating RA. However, the monotherapy data reinforces the use of tofacitinib citrate as an oral option for patients to manage their RA without the need for methotrexate.”

Tofacitinib citrate is approved in more than 45 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).

Tofacitinib citrate is not currently approved for use by the European Medicines Agency (EMA). A marketing authorization application for tofacitinib citrate 5 mg BID is currently under review by the EMA for the treatment of patients with moderate to severe RA who have had an inadequate response or intolerance to methotrexate.

Treatment Approaches

A number of analyses offer information to help guide physicians on treatment approaches for the use of tofacitinib citrate in moderate to severe RA. These include findings further contextualizing the safety profile of tofacitinib citrate as well as long-term data:

• Tofacitinib, An Oral Janus Kinase Inhibitor, In The Treatment Of Rheumatoid Arthritis: Changes In Lymphocytes And Lymphocyte Subset Counts And Reversibility After Up To 8 Years Of Tofacitinib Treatment [THU0199, Thursday, June 9]
• Persistence Of Tofacitinib In The Treatment Of Rheumatoid Arthritis In Open-label, Long-term Extension Studies Up to 7 Years [THU0169, Thursday, June 9]
• Tofacitinib, An Oral JAK Inhibitor, In The Treatment Of Rheumatoid Arthritis: Safety And Clinical And Radiographic Efficacy In Open-label, Long-term Extension Studies Over 7 Years [THU0185, Thursday, June 9]
• Assessment of Immunogenicity of Live Zoster Vaccination in Rheumatoid Arthritis Patients on Background Methotrexate Before and After Initiating Tofacitinib or Placebo [FRI0110, Friday, June 10]

Providing Evidence for tofacitinib citrate as Monotherapy

Data supporting the use of tofacitinib citrate as monotherapy – without the need for methotrexate – include real-world efficacy results, as well as additional safety data:

• Clinical Outcomes Of Rheumatoid Arthritis Patients Receiving Tofacitinib Monotherapy In The Open-label Long-term Extension [THU0202, Thursday, June 9]
• Lack Of Early Change In Disease Activity Score Predicts The Likelihood Of Achieving Low Disease Activity At Month 6: Tofacitinib Monotherapy Versus Methotrexate In Methotrexate-Naïve Patients With Rheumatoid Arthritis [THU0180, Thursday, June 9]
• Comparative Effectiveness Of TNFi And Tofacitinib Monotherapy In Clinical Practice: Results From Corrona Registry [THU0132, Thursday, June 9]
• A Safety Analysis Of Tofacitinib 5 Mg Twice Daily Administered As Monotherapy Or In Combination With Background Conventional Synthetic DMARDs In A Phase 3 Rheumatoid Arthritis Population [THU0174, Thursday, June 9]

“The research being presented at the Annual European Congress of Rheumatology (EULAR 2016) illustrates our continued commitment to improving care for patients living with chronic inflammatory conditions, like RA,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “Pfizer continues to advance the understanding of JAK science through the ongoing study of tofacitinib citrate, which has one of the largest RA clinical development programs with respect to the number of patients and patient years of exposure.”