ACR Meeting Abstracts

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  • Abstract Number: 2744 • 2015 ACR/ARHP Annual Meeting

    What Is the Treatment Durability and Safety Profile of Rheumatoid Arthritis Patients Treated with Infliximab Plus Methotrexate and/or Leflunomide? an Analysis from a Real-World Registry

    Rafat Faraawi1, Raman Joshi2, William G Bensen3, Denis Choquette4, Wojciech Olsynzynski5, Regan Arendse5, Maqbool Sheriff6, Proton Rahman7, Emmanouil Rampakakis8, Eliofotisti Psaradellis9, Francois Nantel10, Allen J Lehman11, Susan Otawa11, Cathy Tkaczyk11 and Brendan Osborne11, 1McMaster University, Hamilton, ON, Canada, 2William Osler Health Centre-Brampton Civic Hospital, Brampton, ON, Canada, 3St Joseph's Healthcare Hamilton, Hamilton, ON, Canada, 4Rheumatology Department, Institut de Rhumatologie de Montréal and University of Montreal, Montreal, QC, Canada, 5University of Saskatchewan, Saskatoon, ON, Canada, 6Nanaimo Regional General Hospital, Nanaimo, BC, Canada, 7Medicine, Memorial University, St John's, NF, Canada, 8JSS Medical Research, St-Laurent, QC, Canada, 9JSS Medical Research, Montreal, QC, Canada, 10Janssen Inc., Toronto, ON, Canada, 11Medical Affairs, Janssen Inc., Toronto, ON, Canada

    Background/Purpose: Clinical trials of anti-TNF therapies have shown that concurrent methotrexate (MTX) therapy enhances the efficacy of TNF inhibitors. A scarcity of data exists on…
  • Abstract Number: 2745 • 2015 ACR/ARHP Annual Meeting

    Real World Evaluation of Patients with Rheumatoid Arthritis Initiating Tofacitinib Vs. Adalimumab and Etanercept

    Benjamin Chastek1, James Harnett2, Jeffrey R. Curtis3, Robert Gerber4, David Gruben4, Rui Song5 and Andrew Koenig6, 1Optum Insight, Eden Prairie, MN, 2Pfizer Inc, New York, NY, 3University of Alabama at Birmingham, Birmingham, AL, 4Pfizer Inc, Groton, CT, 5Optum Insight, Reston, VA, 6Pfizer Inc, Collegeville, PA

    Background/Purpose:  In November 2012, the first oral Janus kinase (JAK) inhibitor tofacitinib was approved in the US for the treatment of RA with or without…
  • Abstract Number: 2746 • 2015 ACR/ARHP Annual Meeting

    Comparison Study of Tests Available to Monitor Tocilizumab Therapy in Rheumatic Patients

    Sergio Martín1,2, Ainhoa Ruiz del Agua2, Nerea Torres2, Dora Pascual-Salcedo3, Chamaida Plasencia4, Teresa Jurado5, Alejandro Balsa6, Begoña Ruiz-Argüello2, Antonio Martínez2, Rosaura Navarro7 and Daniel Nagore2, 1Department of Physiology, Medicine and Dentistry School, University of the Basque Country UPV/EHU (Convocatoria ZabaldUZ, UPV/EHU; Departamento de Educación, Universidades e Investigación del Gobierno Vasco, Ref. IT687-13), Leioa, Spain, 2R&D, Progenika-Grifols, Derio, Spain, 3Immunology Unit, La Paz University Hospital-Immunology, Madrid, Spain, 4Rheumatology Unit, La Paz University Hospital-Rheumatology, Madrid, Spain, 5Immunology, La Paz University Hospital-Idipaz, Madrid, Spain, 6Rheumatology, La Paz University Hospital-Rheumatology Department, Madrid, Spain, 7Department of Physiology, Medicine and Dentistry School, University of the Basque Country UPV/EHU, Leioa, Spain

    Background/Purpose: The options for treatment of rheumatic diseases is constantly growing. Tocilizumab (TCZ) is an anti-interleukin 6 receptor monoclonal antibody indicated for the treatment of severe…
  • Abstract Number: 2747 • 2015 ACR/ARHP Annual Meeting

    Study Completion and Etanercept Retention in Patients with Rheumatoid Arthritis Treated with Etanercept Monotherapy Versus Etanercept and Methotrexate Combination Therapy

    Janet E. Pope1, Edward C. Keystone2, J Carter Thorne3, Melanie Poulin-Costello4, Krystene Phan-Chronis4 and Boulos Haraoui5, 1University of Western Ontario, London, ON, Canada, 2Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, 3Southlake Regional Health Centre, Newmarket, ON, Canada, 4Amgen Canada Inc., Mississauga, ON, Canada, 5University of Montreal Hospital Centre, Montreal, QC, Canada

    Background/Purpose: The CAnadian Methotrexate and Etanercept Outcome (CAMEO) study, an open-label trial in patients with active rheumatoid arthritis (RA), revealed that patients achieving low disease…
  • Abstract Number: 2748 • 2015 ACR/ARHP Annual Meeting

    Evaluation of Patient-Reported Outcomes By Baseline Disease Duration: 6-Month Data from Two Clinical Trials of Patients with Early Rheumatoid Arthritis Treated with Abatacept

    Daniel E. Furst1, VP Bykerk2, Gerd Burmester3, BG Combe4, T. W. J. Huizinga5, E Alemao6, A Johnsen6 and Paul Emery7, 1Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 2Weill Cornell Medical College, New York, NY, 3Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany, 4Montpellier University, Montpellier, France, 5Leiden University Medical Center, Leiden, Netherlands, 6Bristol-Myers Squibb, Princeton, NJ, 7University of Leeds, Leeds, United Kingdom

    Background/Purpose: Patients with RA and longer disease duration generally do not respond as well to treatment with DMARDs as patients with shorter duration of disease.…
  • Abstract Number: 2749 • 2015 ACR/ARHP Annual Meeting

    A Phase 1 Study of FPA008, an Anti-Colony Stimulating Factor 1 Receptor (anti-CSF1R) Antibody in Patients (pts) with Rheumatoid Arthritis (RA): Preliminary Results

    Lei Zhou1, Robert Sikorski1, Seema Rogers1, Stefan Costin2, Mariusz Korkosz3, Maria Jaraczewska-Baumann4, Péterfai Éva5, Bernadette Rojkovich6, Janos Bartalos7, Emma Masteller1, Hong Xiang1, Brian Wong1 and Julie Hambleton1, 1Five Prime Therapeutics, Inc., South San Francisco, CA, 2PRA Heath Sciences, Berlin, Germany, 3Malopolskie Centrum Medyczne, The University Hospital in Krakow, Krakow, Poland, 4MedPolonia Sp. z o.o, Poznan, Poland, 5Drug Research Center, Balatonfüred, Hungary, 6Hospitaller Brothers of St. John of God, Budapest, Hungary, 7PRA Hungary Ltd, Budapest, Hungary

    Background/Purpose: FPA008 is a humanized IgG4 anti-CSF1R antibody that blocks the binding of CSF1 and IL34 ligands to CSF1R, resulting in inhibition of the activation…
  • Abstract Number: 2750 • 2015 ACR/ARHP Annual Meeting

    Tocilizumab Is Effective As 1st, 2nd and 3rd-Line Biologic DMARD in Patients with Rheumatoid Arthritis

    Adrian Richter1, Anja Strangfeld2, Joern Kekow3, Arnold Bussmann4, Andreas Krause5, Carsten Stille6, Joachim Listing7 and Angela Zink8, 1German Rheumatism Research Center, Berlin, Germany, 2Epidemiology, German Rheumatism Research Center, Berlin, Germany, 3University of Magdeburg, Magdeburg, Germany, 4Rheumatologist, Geilenkirchen, Germany, 5Rheumatologist, Berlin, Germany, 6Rheumatologist, Hannover, Germany, 7Epidemiology, DRFZ, Berlin, Germany, 8Epidemiologie, Deutsches Rheuma-Forschungszentrum, Berlin, Germany

    Background/Purpose: In Germany, treatment with Tocilizumab (TCZ) is primarily used in rheumatoid arthritis patients with previous failures of biologic DMARDs. Effectiveness and adherence of TCZ…
  • Abstract Number: 2751 • 2015 ACR/ARHP Annual Meeting

    Assessment of the Effect of CYP3A Inhibition, CYP Induction, OATP1B Inhibition and Administration of High-Fat Meal on the Pharmacokinetics of the Potent and Selective JAK1 Inhibitor ABT-494

    Mohamed-Eslam Mohamed1, Steven Jungerwirth2, Armen Asatryan1, Ping Jiang2 and Ahmed Othman1, 1AbbVie, North Chicago, IL, 2AbbVie Inc., North Chicago, IL

    Background/Purpose: ABT‑494 is an oral selective JAK1 inhibitor that is being developed for treatment of rheumatoid arthritis and Crohn’s disease.  ABT-494 is metabolized by cytochrome…
  • Abstract Number: 2752 • 2015 ACR/ARHP Annual Meeting

    Profile of Joint Involvement over Time in Rheumatoid Arthritis and Psoriatic Arthritis Patients Treated with Anti-TNF in a Real-World Setting

    Algis Jovaisas1, Michael Starr2, Denis Choquette3, Michel Zummer4, Regan Arendse5, Dalton Sholter6, Rafat Faraawi7, Jude Rodrigues8, Emmanouil Rampakakis9, John S. Sampalis9, Francois Nantel10, Allen J Lehman11, Susan Otawa11, May Shawi10 and Karina Maslova10, 1Capital North Therapeutics & Research, Ottawa, ON, Canada, 2Rheumatology, McGill University, Montreal, QC, Canada, 3Rheumatology, Institut de recherche en rhumatologie de Montréal (IRRM), Montréal, QC, Canada, 4Université de Montréal, Quebec, QC, Canada, 5University of Saskatchewan, Saskatoon, SK, Canada, 6Rheumatology Associates, Edmonton, AB, Canada, 7McMaster University, Hamilton, ON, Canada, 8Jude Rodrigues Medicine Professional Corporation, Windsor, ON, Canada, 9JSS Medical Research, St-Laurent, QC, Canada, 10Janssen Inc., Toronto, ON, Canada, 11Medical Affairs, Janssen Inc., Toronto, ON, Canada

    Background/Purpose: :  Unlike rheumatoid arthritis (RA), the pattern of joint involvement in psoriatic arthritis (PsA) is usually asymmetric. Furthermore, PsA may demonstrate oligoarthritis or polyarthritis,…
  • Abstract Number: 2753 • 2015 ACR/ARHP Annual Meeting

    Effectiveness and Safety of Tocilizumab in Biologics-Naive RA Patients – Postmarketing Surveillance for Investigating Success in Achieving Clinical and Functional Remission and Sustaining Efficacy with Tocilizumab in Biologics-Naive RA Patients (FIRST Bio) Study

    Naoki Ishiguro1, Tatsuya Atsumi2, Masayoshi Harigai3, Tsuneyo Mimori4, Norihiro Nishimoto5, Takayuki Sumida6, Tsutomu Takeuchi7, Yoshiya Tanaka8, Nobuhiro Takagi9, Ayako Nakasone10 and Hisashi Yamanaka11, 1Department of Orthopedic Suregery, Nagoya University Hospital, Nagoya, Japan, 2Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, 3Department of Phamacovigilance, Tokyo Medical and Dental University, Tokyo, Japan, 4Dept of Rheum & Clinical Immun, Kyoto Univ Grad Schl of Med, Kyoto, Japan, 5Osaka Rheumatology Clinic, Osaka, Japan, 6Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan, 7Keio University School of Medicine, Tokyo, Japan, 8The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 9Medical Science, Chugai Pharmaceutical, Tokyo, Japan, 10Chugai Pharmaceutical Co. Ltd, Tokyo, Japan, 11Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan

    Background/Purpose: The all-patient postmarketing surveillance (PMS) of tocilizumab (TCZ; PMS7901), which followed 7901 rheumatoid arthritis (RA) patients for 28 weeks (wks), showed that patients with…
  • Abstract Number: 2754 • 2015 ACR/ARHP Annual Meeting

    Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of BI 655064, an Antagonistic Anti-CD40 Antibody Following Single-Dose Administration in Chinese and Japanese Healthy Volunteers

    Jiyoon Kim1, Yasuhiro Tsuda2, Kazuhiko Yamamoto3, Ralf Thiedmann4, Corinna Schoelch4, Stephen Norris5, Steven Padula6, Juergen Steffgen4 and In-Jin Jang7, 1Boehringer Ingelheim Korea Ltd., Seoul, South Korea, 2Clinical PK/PD department, Nippon Boehringer-Ingelheim.Co.,Ltd., Kobe, Japan, 3Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, 4Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, 5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, 6Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, 7Seoul National University Hospital, Seoul, South Korea

    Background/Purpose: The CD40-CD40L pathway may play a major role in autoimmune disorders like rheumatoid arthritis or SLE. Blocking this pathway may be a promising new…
  • Abstract Number: 2755 • 2015 ACR/ARHP Annual Meeting

    Evaluating Pharmacokinetic Predictors of Tofacitinib Clinical Response in Rheumatoid Arthritis

    Manisha Lamba1, Daniel E. Furst2, Ara Dikranian3, Martin Dowty1, Matthew M Hutmacher4, Daniela Conrado1, Thomas Stock5, Chudy Nduaka5 and Sriram Krishnaswami1, 1Pfizer Inc, Groton, CT, 2Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 3San Diego Arthritis Medical Clinic, San Diego, CA, 4Ann Arbor Pharmacometrics Group, Ann Arbor, MI, 5Pfizer Inc, Collegeville, PA

    Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. A modified-release (MR) formulation to provide a once-daily (QD) dosing alternative to…
  • Abstract Number: 2756 • 2015 ACR/ARHP Annual Meeting

    Impact of Tocilizumab Monotherapy on Patient-Reported Quality of Life Outcomes in the US Corrona Registry

    Leslie Harrold1,2, Ani John3, George W. Reed2,4, Chitra Karki2, YouFu Li4, Joel M. Kremer5, Tmirah Haselkorn6 and Jeffrey D. Greenberg2,7, 1Department of Orthopedics and Medicine, University of Massachusetts Medical School, Worcester, MA, 2Corrona, LLC, Southborough, MA, 3Genentech, Inc., South San Francisco, CA, 4University of Massachusetts Medical School, Worcester, MA, 5Albany Medical College, Albany, NY, 6Genentech, Inc, South San Francisco, CA, 7NYU School of Medicine, New York, NY

    Background/Purpose: The objective of this real-world analysis was to examine the impact of the interleukin-6 receptor α inhibitor tocilizumab (TCZ) on patient-reported outcomes (PROs) in…
  • Abstract Number: 2757 • 2015 ACR/ARHP Annual Meeting

    Secondary Efficacy Endpoints: Results from a Phase 3 Study Comparing ABP 501 with Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

    Alan K. Matsumoto1, Karel Pavelka2, Warren Rizzo3, Ramesh Gupta4, William Shergy5, Pawel Heycaj6, Nan Zhang7 and Primal P. Kaur8, 1Rheumatology, Arthritis & Rheumatism Assoc, Wheaton, MD, 2Charles University, Prague, Czech Republic, 3Advanced Arthritis Care & Research, Scottsdale, AZ, 4Private Practice, Rheumatology, Memphis, TN, 5RANA Clinical Research Center, Huntsville, AL, 6Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, 7Biosimilars, Amgen, Inc., Thousand Oaks, CA, 8Amgen, Inc., Thousand Oaks, CA

    Background/Purpose: ABP 501 is being developed as a biosimilar candidate to adalimumab (Humira®), a fully human recombinant monoclonal antibody. Evidence from analytical and pharmacokinetic comparisons…
  • Abstract Number: 2758 • 2015 ACR/ARHP Annual Meeting

    Clinical Utility and Factors Associated with Certolizumab Pegol Drug Levels and Anti-Drug Antibodies in the Long-Term Treatment of Rheumatoid Arthritis

    Meghna Jani1, Hector Chinoy1,2, John Isaacs3, Ann W. Morgan4, Anthony Wilson5, Kimme L. Hyrich6, Darren Plant1,2 and Anne Barton1,7, 1Centre for Musculoskeletal Research, University of Manchester, Manchester, United Kingdom, 2NIHR Manchester Musculoskeletal Biomedical Research Unit, Manchester Academy of Health Sciences, Manchester, United Kingdom, 3National Institute for Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle, United Kingdom, 4NIHR-Leeds Musculoskeletal Biomedical Research Unit, Leeds & Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, 5Infection & Immunity, University of Sheffield, Sheffield, United Kingdom, 6Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, United Kingdom, 7NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester Foundation Trust and University of Manchester, Manchester Academy of Health Sciences, Manchester, United Kingdom

    Background/Purpose: Up to 40% of RA patients on anti-TNF agents fail to respond either due to primary or secondary inefficacy. One explanation is immunogenicity leading…
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