Abstracts tagged "treatment"

Abstract Number: 441 • 2013 ACR/ARHP Annual Meeting
Tofacitinib, An Oral Janus Kinase Inhibitor: Safety Comparison In Patients With Rheumatoid Arthritis and An Inadequate Response To Nonbiologic Or Biologic Disease‑Modifying Anti-Rheumatic Drugs
G. R. Burmester¹, C Charles-Schoeman², J. D. Isaacs³, T. Hendrikx⁴, K. Kwok⁵, S. H. Zwillich⁶ and R. Riese⁶, ¹Department of Medicine/Rheumatology and Clinical Immunology and German Rheumatism Research Centre Berlin (DRFZ), Charité University Medicine Berlin, Berlin, Germany, ²University of California, Los Angeles, CA, ³Newcastle University, Newcastle-upon-Tyne, United Kingdom, ⁴Pfizer BV, Capelle aan den IJssel, Netherlands, ⁵Pfizer Inc, New York, NY, ⁶Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis provides comparative safety data on the incidence…
Abstract Number: 2355 • 2013 ACR/ARHP Annual Meeting
Sarilumab, a Subcutaneously-Administered, Fully-Human Monoclonal Antibody Against The IL-6 Receptor Alpha: Using Acute Phase Reactants, Efficacy and Safety Parameters To Inform Phase 3 Dose Selection
Janet van Adelsberg¹, Steven P. Weinstein², Neil Graham³, Tanya Momtahen⁴, Chunpeng Fan⁵ and Stefano Fiore⁶, ¹Clinical Science, Regeneron Pharmaceutials, Inc., Tarrytown, NY, ²Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, NY, ³Program Direction, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁴Program Direction, Sanofi, Bridgewater, NJ, ⁵Biostatistics, Sanofi, Bridgewater, NJ, ⁶Clinical Science, Sanofi, Bridgewater, NJ
Background/Purpose: Sarilumab (SAR) is a fully human mAb directed against IL-6Rα. In phase 2 MOBILITY Part A (NCT01061736), SAR administered SC plus MTX (methotrexate 10-25…
Abstract Number: 1454 • 2013 ACR/ARHP Annual Meeting
The Effects Of The Spleen Tyrosine Kinase Inhibitor Fostamatinib On Ambulatory Blood Pressure In Patients With Active Rheumatoid Arthritis – Results Of The Oskira Ambulatory Blood Pressure Monitoring Trial
G Kitas¹, G Abreu², K Jedrychowicz-Rosiak³, J Miller⁴, R Nakov², S Panfilov², J Vencovsky⁵, M Wang⁶, M Weinblatt⁷ and WB White⁸, ¹The Dudley Group of Hospitals NHS Foundation Trust, Dudley, United Kingdom, ²AstraZeneca, Molndal, Molndal, Sweden, ³MCBK SC, Grodzisk Mazowiecki, Poland, ⁴S.W. Florida Clinical Research Center, Florida, FL, ⁵Institute of Rheumatology, Prague, Czech Republic, ⁶AstraZeneca, Alderley Park, Macclesfield, United Kingdom, ⁷Brigham and Women's Hospital, Boston, MA, ⁸Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT
Background/Purpose: Fostamatinib (Fosta) is a spleen tyrosine kinase (SYK) inhibitor in clinical trials in patients (pts) with rheumatoid arthritis (RA). Previous clinical studies showed blood…
Abstract Number: 442 • 2013 ACR/ARHP Annual Meeting
Tolerability and Non-Serious Adverse Events In Rheumatoid Arthritis Patients Treated With Tofacitinib As Monotherapy Or In Combination Therapy
A. Dikranian¹, K. Soma², R. Riese², D. Gruben² and T. V. Jones³, ¹San Diego Arthritis Medical Clinic, San Diego, CA, ²Pfizer Inc, Groton, CT, ³Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). Tolerability remains an ill-defined construct in clinical trials.…
Abstract Number: 2358 • 2013 ACR/ARHP Annual Meeting
Sarilumab, a Subcutaneously Administered, Fully Human Monoclonal Antibody Inhibitor Of The IL-6 Receptor Alpha: 12 Week Infection Rates By Level Of Circulating Neutrophils In Rheumatoid Arthritis and Ankylosing Spondylitis
Kevin L. Winthrop¹, Tanya Momtahen², Stefano Fiore³, Steven P. Weinstein⁴, Janet van Adelsberg⁵, Richard Wu⁶ and Neil Graham⁷, ¹Dept of Infectious Disease, Oregon Health & Science University, Portland, OR, ²Program Direction, Sanofi, Bridgewater, NJ, ³Clinical Science, Sanofi, Bridgewater, NJ, ⁴Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, NY, ⁵Clinical Science, Regeneron Pharmaceutials, Inc., Tarrytown, NY, ⁶BioStatistics, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ⁷Program Direction, Regeneron Pharmaceuticals, Inc., Tarrytown, NY
Background/Purpose: Sarilumab is a human monoclonal antibody directed against the alpha subunit of the IL-6 receptor (IL-6Rα). IL-6 blockade is associated with a reduction in…
Abstract Number: 1418 • 2013 ACR/ARHP Annual Meeting
Effects Of Smoking Status On Response To Treatment With Tofacitinib In Patients With Rheumatoid Arthritis
J. M. Kremer¹, J. D. Greenberg², C. Turesson³, D. Gruben⁴, C. A. Mebus⁴, E. Bananis⁵ and T. Robinson⁶, ¹Albany Medical College and The Center for Rheumatology, Albany, NY, ²Rheumatology, NYU Hospital for Joint Diseases, New York, NY, ³Lund University, Malmö, Sweden, ⁴Pfizer Inc, Groton, CT, ⁵Specialty Care, Pfizer Inc, Collegeville, PA, ⁶Pfizer Inc, Collegeville, PA
Background/Purpose: Cigarette smoking is a known risk factor for developing rheumatoid arthritis (RA).1 Several recent observational studies suggest that cigarette smoking may be associated with…
Abstract Number: 443 • 2013 ACR/ARHP Annual Meeting
Efficacy and Safety Analyses Of Tofacitinib From Pooled Phase 2, Phase 3 and Long-Term Extension Rheumatoid Arthritis Studies: US Compared With Non-US Populations
S. B. Cohen¹, Roy Fleischmann¹, J. M. Kremer², A. Koenig³, K. Kwok⁴, L. Wang⁵, C. a. Mebus⁵, R. Riese⁵ and T. Robinson³, ¹Metroplex Clinical Research Center, Dallas, TX, ²Albany Medical College and The Center for Rheumatology, Albany, NY, ³Pfizer Inc, Collegeville, PA, ⁴Pfizer Inc, New York, NY, ⁵Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor approved in the US for the treatment of rheumatoid arthritis at 5 mg BID. Phase (P) 3…
Abstract Number: 2331 • 2013 ACR/ARHP Annual Meeting
Efficacy and Safety Of Tofacitinib In Older and Younger Patients With Rheumatoid Arthritis
J. R. Curtis¹, H. Schulze-Koops², L Takiya³, C. A. Mebus⁴, K. Terry⁴, R. Chew⁴ and T. V. Jones³, ¹Rheumatology & Immunology, University of Alabama at Birmingham, Birmingham, AL, ²University of Munich, Munich, Germany, ³Pfizer Inc, Collegeville, PA, ⁴Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is a novel, oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The clinical development program for tofacitinib in RA enrolled ˃500…
Abstract Number: 1387 • 2013 ACR/ARHP Annual Meeting
Reversing Vascular Dysfunction In Rheumatoid Arthritis: Peroxisome Proliferator-Activated Receptor Gamma Agonist Therapy Improves Augmentation Index But Not Endothelial Function
Michelle J. Ormseth¹, Aihua Bian², Annette M. Oeser², Andrew Cunningham², Ayumi Shintani², S. Bobo Tanner³ and C. Michael Stein⁴, ¹Rheumatology, Vanderbilt Medical Center, Nashville, TN, ²Vanderbilt Medical Center, Nashville, TN, ³Div of Rheumatology & Allergy, Vanderbilt Medical Center, Nashville, TN, ⁴School of Medicine, Division of Clinical Pharmacology, Vanderbilt Medical Center, Nashville, TN
Background/Purpose: Rheumatoid arthritis (RA) is associated with insulin resistance and increased cardiovascular (CV) risk. Impaired vascular function, including arterial stiffness and endothelial dysfunction, is associated…
Abstract Number: 445 • 2013 ACR/ARHP Annual Meeting
Post-Hoc Analysis Of Serious Infection Events and Selected Clinical Factors In Rheumatoid Arthritis Patients Treated With Tofacitinib
J. J. Gomez-Reino¹, A. Hazra², C. Fosser², S. Menon³, S. H. Zwillich², R. Riese² and S. Krishnaswami³, ¹Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, ²Pfizer Inc, Groton, CT, ³Clinical Pharmacology, Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is a novel oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). Serious infections (requiring hospitalization or parenteral antibiotics; SIEs)…
Abstract Number: 2334 • 2013 ACR/ARHP Annual Meeting
ORAL SCAN: Effects Of The Oral JAK Inhibitor Tofacitinib In Combination With Methotrexate On Patient Reported Outcomes In a 24-Month Phase 3 Trial Of Active Rheumatoid Arthritis
V. Strand¹, D. van der Heijde², C. a. F. Zerbini³, C. A. Connell⁴, D. Gruben⁴, R. Riese⁴ and G. Wallenstein⁴, ¹Adjunct, Division of Immunology / Rheumatology, Stanford University, Palo Alto, CA, ²Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ³Rheumatology, Centro Paulista de Investigação Clinica, Sao Paulo, Brazil, ⁴Pfizer Inc, Groton, CT
Background/Purpose: Tofacitinib is an oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). Efficacy, inhibition of structural damage, and safety of tofacitinib…
Abstract Number: 1391 • 2013 ACR/ARHP Annual Meeting
Transporters As Drug Gateway Into The Cell For Specific Targeting Of Tyrosine Kinase Signaling Pathway In Rheumatoid Arthritis
Saliha Harrach¹, Christian Schmidt-Lauber², Bayram Edemir³, Eberhard Schlatter¹, Thomas Pap⁴, Giuliano Ciarimboli¹ and Jessica Bertrand², ¹Experimental Nephrology, Medical Clinic und Policlinic D, University Hospital Münster, Münster, Germany, ²Institute of Experimental Musculoskeletal Medicine (IEMM), University Hospital Münster, Münster, Germany, ³Experimental Nephrology, Medical Clinic und Policlinic D, University Hospital Münster, Muenster, Germany, ⁴Institute of Experimental Muskuloskeletal Medicine, University Hospital Münster, Münster, Germany
Background/Purpose: Tyrosine kinase inhibitors (TKI) are effective in treating malignant disorders and were suggested to also have an impact on non-malignant diseases such as rheumatoid…
Abstract Number: 455 • 2013 ACR/ARHP Annual Meeting
Oskira-2: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study Of 2 Dosing Regimens Of Fostamatinib In Rheumatoid Arthritis Patients With An Inadequate Response To Disease-Modifying Antirheumatic Drugs
Peter Dawes¹, Aleksandar Dimic², Mark C. Genovese³, Désiréé van der Heijde⁴, Martin Jenkins⁵, Chris O'Brien⁶, Barry Oemar⁷, Jiri Vencovsky⁸ and Michael Weinblatt⁹, ¹Department of Rheumatology, University of North Staffordshire NHS Trust, Stoke-on-Trent, United Kingdom, ²Rheumatology Institute, Niška Banja, Serbia, ³Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, ⁴Leiden University Medical Center, Leiden, Netherlands, ⁵AstraZeneca R&D Alderley Park, Macclesfield, United Kingdom, ⁶AstraZeneca R&D Wilmington, Wilmington, DE, ⁷AstraZeneca R&D Boston, Boston, MA, ⁸Department of Clinical and Experimental Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Institute of Rheumatology, Prague, Czech Republic, ⁹Division of Rheumatology, Brigham & Women's Hospital, Boston, MA
Background/Purpose: Fostamatinib (Fosta) is a novel spleen tyrosine kinase (SYK) inhibitor. The Phase II TASKi studies showed benefit in patients (pts) with active rheumatoid arthritis…
Abstract Number: 2336 • 2013 ACR/ARHP Annual Meeting
Phase 2 Evaluation Of PF-04171327, a Dissociated Agonist Of The Glucocorticoid Receptor, For The Treatment Of Rheumatoid Arthritis In Patients With An Inadequate Response To Methotrexate
Thomas Stock¹, Dona Fleishaker², Xin Wang², Arnab Mukherjee² and Charles Mebus², ¹Pfizer Inc., Collegeville, PA, ²Pfizer Inc., Groton, CT
Background/Purpose: PF-04171327, a pro drug of PF-00251802, is under investigation as a potential dissociated agonist of the glucocorticoid receptor (DAGR). PF-00251802 is a selective high-affinity…
Abstract Number: 1337 • 2013 ACR/ARHP Annual Meeting
Nearly Pain Free Self-Administration Of Methotrexate Using An Investigational Auto-Injector: Results Of a Phase-2 Clinical Trial In Rheumatoid Arthritis Patients With Mild-To-Severe Functional Limitations
Alan J. Kivitz¹, David McLain², John Hill³, Bruce Freundlich⁴, Jonathan Jaffe⁵ and Kaushik J. Dave⁶, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Rheumatology, McLain Medical Associates, PC, Birmingham, AL, ³Avail Clinical Research, DeLand, FL, ⁴University of Pennsylvania, Philadelphia, PA, ⁵Clinical Development, Antares Pharma Inc, Ewing, NJ, ⁶Product Development, Antares Pharma Inc, Ewing, NJ
Background/Purpose: Methotrexate (MTX) is the cornerstone of rheumatoid arthritis (RA) treatment. Limitations of systemic exposure of oral MTX can affect its efficacy. Subcutaneous (SC) MTX…

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