Pfizer (PFE) Announces Presentation of Additional XELJANZ Data at 2016 ACR/ARHP Annual Meeting

November 7, 2016 6:47 AM EST

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Pfizer Inc. (NYSE: PFE) 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.

Pfizer-sponsored research at the 2016 ACR/ARHP Annual Meeting includes the following presentations:

XELJANZ RA

Oral Presentations

  • Major Adverse Cardiovascular Events: Risk Factors in Patients with RA Treated with Tofacitinib [#3024, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III: Small Molecules and Early Intervention, Nov. 15, 2016, 2:30-4p.m.]
  • Inflammation Detected with Modern Sensitive MRI Analysis Demonstrates that Therapeutic Response as Early as One Month Predicts 12-Month Radiographic Progression: Data from a Study Using Tofacitinib and Methotrexate in Early RA [#3090, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy IV: Biomarkers, Nov. 15, 2016, 4:30-6p.m.]

Poster Presentations

  • Magnitude and Duration of Early Response with Tofacitinib: Post-Hoc Analysis of Two Phase 3, Placebo-Controlled Studies [#1595, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open-Label, Long-Term Extension Studies up to 8 Years [#1602, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • Efficacy of Tofacitinib in Patients who are Inadequate Responders to Disease-Modifying Antirheumatic Drugs According to Early Versus Late Duration of Rheumatoid Arthritis: Post-Hoc Analysis of Data from Phase 3 trials [#1609, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • Tofacitinib: Treatment Outcomes in Seropositive Versus Seronegative Patients in a Phase 3 RA Population [#1643, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • Discontinuation of Methotrexate or Glucocorticoids in Patients with Rheumatoid Arthritis Treated with Tofacitinib: Clinical Efficacy Data from Long-Term Extension Studies [#1646, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Rheumatoid Arthritis: Safety and Efficacy in Open-Label, Long-Term Extension Studies over 8 Years [#1647, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • Long-Term Clinical, Radiographic and Patient-Reported Outcomes Based on RAPID3 Responses with Tofacitinib at 6 Months [#1648, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • Evaluation of Disease Activity in Patients with Rheumatoid Arthritis Treated with Tofacitinib by RAPID3: An Analysis of Data from 6 Phase 3 Studies [#1600, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • 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 [#1608, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II, Nov. 14, 2016, 9-11a.m.]
  • Real World Results from a Post-Approval Safety Surveillance of Tofacitinib (Xeljanz): Over 3 Year Results from an Ongoing US-Based Rheumatoid Arthritis Registry [#2595, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster III, Nov. 15, 2016, 9-11a.m.]
  • Effect of Glucocorticoids on Clinical and Radiographic Efficacy Outcomes in Methotrexate-Naïve Patients with RA Receiving Tofacitinib or Methotrexate Monotherapy: Analysis of Data from a Phase 3 Trial [#2606, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster III, Nov. 15, 2016, 9-11a.m.]
  • The Effectiveness of Zoster Vaccine in RA Patients Subsequently Treated up to 19 Months with Tofacitinib [#2609, Session: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster III, Nov. 15, 2016, 9-11a.m.]

XELJANZ Investigational Research Areas

Oral Presentations

  • Treatment with Tofacitinib is Associated with Clinically Meaningful Reductions in Axial MRI Inflammation in Patients with Ankylosing Spondylitis [#1044, Session: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment II: Axial Spondyloarthritis – Treatment, Nov. 13, 2016, 4:30-6p.m.]
  • Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, or Adalimumab in Patients With Active Psoriatic Arthritis and An Inadequate Response to Conventional Synthetic DMARDs: A Randomized, Placebo controlled, Phase 3 Trial [#2983, Session: Plenary Session III: Discovery 2016, Nov. 15, 2016, 11a.m.-12:30p.m.]

Poster Presentations

  • Efficacy and Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Patients with Active Psoriatic Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitors: OPAL Beyond, a Randomized, Double Blind, Placebo-Controlled, Phase 3 Trial [#10L, Late-breaking Abstract Poster Session, Nov. 13, 2016, 9-11a.m.]
  • Pharmacokinetics, safety, and tolerability of tofacitinib in pediatric patients from two to less than eighteen years of age with juvenile idiopathic arthritis [#388, Session: Pediatric Rheumatology – Clinical and Therapeutic Aspects - Poster I: Juvenile Idiopathic Arthritis, Uveitis, Nov. 13, 2016, 9-11a.m.]

Additional Pfizer-Sponsored Abstracts

Poster Presentations

  • Understanding the Importance of a Patient’s Role in the Management of RA: Physician- and Patient-Based Survey [#81, Session: Health Services Research - Poster I, Nov. 13, 2016, 9-11a.m.]
  • Treatment Patterns, Unmet Need, and Impact of Psoriatic Arthritis on Patient-Reported Outcomes in the United States [#2729, Session: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster III, Nov. 15, 2016, 9-11a.m.]

About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib citrate) extended-release

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.



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