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  • Abstract Number: 460 • 2014 ACR/ARHP Annual Meeting

    Analysis of Non-Melanoma Skin Cancer Across the Tofacitinib Rheumatoid Arthritis Clinical Program

    Jeffrey R. Curtis1, E.B. Lee2, G. Martin3, X. Mariette4, K.K. Terry5, Y. Chen6, J. Geier7, J. Andrews5, M. Kaur6, K. Kwok7 and C. Nduaka5, 1University of Alabama at Birmingham, Birmingham, AL, 2Seoul National University College of Medicine, Seoul, South Korea, 3Dermatology and Laser Center of Maui, Kihei, HI, 4Paris-Sud University, Paris, France, 5Pfizer Inc, Groton, CT, 6Pfizer Inc, Collegeville, PA, 7Pfizer Inc, New York, NY

    Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). The incidence of non-melanoma skin cancer (NMSC) in the tofacitinib…
  • Abstract Number: 459 • 2014 ACR/ARHP Annual Meeting

    Evaluation of the Effect of Tofacitinib on Measured Glomerular Filtration Rate in Patients with Active Rheumatoid Arthritis

    J. Kremer1, A.J. Kivitz2, J.a. Simon Campos3, E.L. Nasonov4, H. Tony5, B. Vlahos6, C. Hammond6, J. Bukowski6, H. Li6, S. Schulman6, S. Raber7, A. Zuckerman8 and J. Isaacs9, 1Albany Medical College and The Center for Rheumatology, Albany, NY, 2Altoona Center for Clinical Research, Duncansville, PA, 3Hospital CEM/BIOCEM, Merida, Mexico, 4Nasonova State Institute of Rheumatology, Moscow, Russia, 5University Hospital Würzburg, Würzburg, Germany, 6Pfizer Inc, Collegeville, PA, 7Pfizer Inc, San Diego, CA, 8Pfizer Inc, Groton, CT, 9National Institute for Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle, United Kingdom

    Background/Purpose: In the clinical development program of the oral Janus kinase inhibitor tofacitinib for the treatment of rheumatoid arthritis (RA), small mean increases in serum…
  • Abstract Number: 478 • 2014 ACR/ARHP Annual Meeting

    Adverse Events and Infections in Patients with Rheumatoid Arthritis Treated with Conventional Drugs or Biologic Agents: A Real World Study

    Christos E. Lampropoulos1, Philippos Orfanos2, Vasiliki-Kalliopi Bournia3, Theofilos P. Karatsourakis4, Clio P. Mavragani5, Dimitrios Pikazis4, Menelaos N. Manoussakis6, Athanasios G. Tzioufas4, Haralampos M. Moutsopoulos7 and Panayiotis G. Vlachoyiannopoulos3, 1Department of Pathophysiology, School of Medicine, National University of Athens, Athens, Greece, 2Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National University of Athens, Athens, Greece, 3First Department of Propedeutic Internal Medicine, Laikon Hospital, Athens University Medical School, Athens, Greece, 4Pathophysiology, School of Medicine, National University of Athens, Athens, Greece, 5Department of Experimental Physiology, School of Medicine, University of Athens, Athens, Greece, Athens, Greece, 6Pathophysiology, School of Medicine, National University of Athens, Greece, Athens, Greece, 7Department of Pathophysiology, School of Medicine, University of Athens, Athens, Greece

    Background/Purpose: Rheumatoid arthritis (RA) is a chronic, inflammatory disease with joint destruction and permanent disability. Biologic agents (BAs) offer a better outcome when disease is…
  • Abstract Number: 477 • 2014 ACR/ARHP Annual Meeting

    Leflunomide Use Is Not Associated with an Increased Risk of Lung Disease in Rheumatoid Arthritis: A Meta-Analysis of Randomised Controlled Trials

    Richard Conway1, Candice Low2, Robert J. Coughlan1, Martin O'Donnell3 and John J. Carey1, 1Rheumatology, Galway University Hospitals, Galway, Ireland, 2Medicine, St. James Hospital, Dublin, Ireland, 3Clinical Research Facility, Galway University Hospitals, Galway, Ireland

    Background/Purpose Leflunomide is an effective treatment for rheumatoid arthritis. An association between pulmonary adverse events, in particular interstitial lung disease, and leflunomide use has been…
  • Abstract Number: 476 • 2014 ACR/ARHP Annual Meeting

    Medium-Term Safety  of TNF-Alpha Inhibitors in Rheumatoid Arthritis: A Meta-Analysis of Randomized Controlled Trials

    Lucile Poiroux1, Yannick Allanore2, Andre Kahan3 and Jerome Avouac4, 1Rhumatologie A, Cochin Hospital, Paris, France, 2Rheumatology, Rheumatology A, Paris Descartes University, Cochin Hospital, APHP, Paris, France, Paris, France, 3Paris Descartes University, Rheumatology A department, Cochin Hospital, Paris, France, 4Cochin Hospital, Paris, France

    Background/Purpose: TNF-a inhibitors have changed the prognosis of rheumatoid arthritis (RA). The number of molecules and the time of exposure have increased. However, few studies…
  • Abstract Number: 475 • 2014 ACR/ARHP Annual Meeting

    Risk Analysis of a First Adverse Event and Recurrent Infections during Biological Therapy in Chronic Inflammatory Arthritis

    G. Avila1, Arnald Alonso1, Andrea Pluma-Sanjurjo2, Carolina Diaz2, Roxana Juverdeanu2, María América López-Lasanta1 and Sara Marsal1, 1Rheumatology Research Group, Vall d'Hebron Hospital Research Institute, Barcelona, Spain, 2Rheumatology, University Hospital Vall d'Hebron, Barcelona, Spain

    Background/Purpose Biological therapies (BT) have significantly improved the prognosis of chronic inflammatory arthritis (CIA) patients. Although they are characterized by a good safety profile, the…
  • Abstract Number: 474 • 2014 ACR/ARHP Annual Meeting

    Renacer Study: Assessment of 12-Month Efficacy and Safety of 168 Certolizumabpegol Rheumatoid Arthritis Treated Patients from a Multicenter Retrospective National Study in Spain

    Vicente Torrente-Segarra1, Ana Urruticoechea2, Héctor Corominas1, Amalia Sánchez3, Juan Víctor Tovar4, Alejandro Muñoz5, Anna Martínez6, José Antonio González4, Manuel Fernández7 and Noelia Vázquez on behalf of RENACER Study Group8, 1Hospital General Hospitalet-Sant Joan Despí Moisès Broggi, Hospitalet Llobregat, Barcelona, Spain, 2Hospital de Can Mises, Ibiza, Spain, 3Hospital Universitario Lucus Augusti, Lugo, Spain, 4Hospital General Universitario de Elche, Alicante, Spain, 5Hospital Universitario de Valme, Sevilla, Spain, 6Hospital La Ribera, Alzira, Valencia, Spain, 7Hospital Universitario de Guadalajara, Guadalajara, Spain, 8Hospital Universitario de Ceuta, Ceuta, Spain

    Background/Purpose: There's scant data of CertolizumabPEGol (CZP) in clinical practice. Study goal: assess efficacy and safety of CZP in RA patients at 3, 6,12-month (m), and…
  • Abstract Number: 473 • 2014 ACR/ARHP Annual Meeting

    Complications of Varicella Zona Virus Infections Are More Frequent in Patients Treated with Biologic Drugs When Combined with Steroids

    Jacques Morel1, Florence Tubach2,3, Yannick Allanore4, Daniel Wendling5, Celine Cozic6, Emmanuelle Dernis Labous7, Eric Legangneux8, Thao Pham9, Sophie Odoit10, Isabelle Roitg11, Isabelle Koné-Paut12, Pierre Quartier13, Jean Sibilia14 and Severine Guillaume Czitrom15, 1Rheumatology, Hopital Lapeyronie, Montpellier, France, 2Département d'Epidémiologie Biostatistique et Recherche Clinique, APHP, Hôpital Bichat, Paris, France, 3INSERM, Universite Paris Diderot, Paris, France, 4Paris Descartes University, Rheumatology A Department and INSERM U1016, Cochin Hospital, Paris, France, 5Service de Rhumatologie, CHU J Minjoz, Besancon, France, 6Rheumatology, CHD la Roche sur Yon, La Roche Sur Yon, France, 7Rhumatologie, Ch Du Mans, Le Mans, France, 8Rheumatology, Centre Hospitalier Public du Cotentin, 50100, France, 9Rheumatology Department, Sainte Marguerite Hospital, Marseille, France, 10Dermatology, CHU de la Réunion, Saint Denis, France, 11Hopital De Perpignan, Perpignan, France, 12Pediatrics Rheumatology, CHU Bicêtre, Le Kremlin Bicêtre, France, 13Pediatric Rheumatology, IMAGINE Institute, Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris, Université Paris-Descartes, Paris, France, 14Division of Rheumatology, University Hospital of Strasbourg, Strasbourg, France, 15Ch De Bicetre, Le Kremlin Bicetre Cedex, France

    Background/Purpose To assess varicella zona virus (VZV) infection features under biological drugs. Methods A call for observations was sent from april 2013 to april 2014…
  • Abstract Number: 471 • 2014 ACR/ARHP Annual Meeting

    Improving of Safety in Treatment with Biologics during First Seven-Years Experiences; Long-Term Results from Observational Cohort Study of Clinical Practice Using Multicenter Registry in Japan

    Toshihisa Kojima1, Nobunori Takahashi1, Koji Funahashi2, Shuji Asai2, Yutaka Yoshioka2, Kenya Terabe2, Nobuyuki Asai2,3, Toki Takemoto2, Naoki Ishiguro1, Atsushi Kaneko4, Yuji Hirano5, Yuichiro Yabe6 and Yasuhide Kanayama7, 1Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan, 2Nagoya University Hospital, Nagoya, Japan, 3Nagoya Univeristy Hospital, Nagoya, Japan, 4Orthopedic Surgery and Rheumatology, Nagoya Medical Center, Nagoya, Japan, 5Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan, 6Rheumatology, JCHO Tokyo Shinjuku Medical Center, Tokyo, Japan, 7Orthopedic Surgery and Rheumatology, Toyota Kosei Hospital, Toyota, Japan

    Background/Purpose: Many evidences including clinical trials of biologics lead us earlier and more aggressive treatment strategy for patients with rheumatoid arthritis (RA). It is stated…
  • Abstract Number: 470 • 2014 ACR/ARHP Annual Meeting

    Safety Profile of Biologic Agents for Rheumatoid Arhtisitis Treatment after the Complication with Methotrexate-Related Lymphoproliferative Disorder

    Shuntaro Saito1, Yuko Kaneko1, Katsuya Suzuki1, Michihide Tokuhira2 and Tsutomu Takeuchi1, 1Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, 2Department of Hematology., Saitama Medical Center, Saitama Medical University., Saitama, Japan

    Background/Purpose Lymphoproliferative disorder (LPD) is a rare complication in patients with rheumatoid arthritis(RA) treated with methotrexate(MTX). Although not a few patients experience exacerbation of RA…
  • Abstract Number: 469 • 2014 ACR/ARHP Annual Meeting

    Safety of Rituximab in Patients with Chronic Inflammatory Arthritis. Seven-Year Follow-up Observational Study

    Andrea Cuervo1, M. Victoria Hernández1, Sonia Cabrera1, Jose Inciarte-Mundo1, Julio Ramirez1, Virginia Ruiz-Esquide1, Juan D. Cañete2 and Raimon Sanmarti1, 1Arthritis Unit. Rheumatology Department, Hospital Clínic of Barcelona, Barcelona, Spain, 2Rheumatology, Hospital Clinic, Barcelona, Spain

    Background/Purpose: Rituximab (RTX) is a biologic therapy approved for the treatment of active rheumatoid arthritis (RA) refractory to tumour necrosis factor antagonists. It causes B…
  • Abstract Number: 468 • 2014 ACR/ARHP Annual Meeting

    Identification of Baseline Risk Factors for Adverse Events in Certolizumab Pegol Treated Rheumatoid Arthritis Patients

    Boulos Haraoui1, John Wade2, Marc de Longueville3, Pauline Ralston4 and Jeffrey R. Curtis5, 1Department of Medicine, Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada, 2Division of Rheumatology, University of British Columbia, and Vancouver General Hospital, Vancouver, BC, Canada, 3SA Global Medical Affairs, UCB Pharma, Brussels, Belgium, 4Giant Professional Ltd, London, United Kingdom, 5Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose Despite efficacy of anti-tumor necrosis factors (anti-TNFs) in treating chronic immune conditions, some patients (pts) report serious adverse events (SAEs) highlighting a need to…
  • Abstract Number: 467 • 2014 ACR/ARHP Annual Meeting

    Evaluation of the Rabbit Risk Score for Serious Infections in a UK Anti-TNF Treatment Cohort

    Lucia Silva-Fernandez1,2, Mark Lunt1, Kath D. Watson1, . BSRBR Control Centre Consortium1, Deborah P. Symmons1, Kimme Hyrich1 and . On behalf of the BSRBR3, 1Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester, United Kingdom, 2Rheumatology, Complexo Hospitalario Universitario de Ferrol, Ferrol, Spain, 3British Society for Rheumatology, London, United Kingdom

    Background/Purpose: Serious infections (SI) are a major concern in patients treated with tumour necrosis factor inhibitors (TNFi). The RABBIT Risk Score (RRS) (1) allows a…
  • Abstract Number: 466 • 2014 ACR/ARHP Annual Meeting

    Should Anti-Tnfa  treatment of RA be Stopped before Orthopedic Surgery?

    Charlotte Mabille1, Adeline Ruyssen Witrand2, Thomas Barnetche3,4, Arnaud Constantin5 and Alain G. Cantagrel5, 1Rheumatology Unit, hopital Purpan, Toulouse, France, 2Rheumatolgy, CHU Purpan - Hôpital Pierre-Paul Riquet, Toulouse, France, 3rheumatology, Rheumatology department, Bordeaux University Hospital, bordeaux, France, 4Rheumatology department, Bordeaux University Hospital, bordeaux, France, 5Rheumatology, CHU Purpan - Hôpital Pierre-Paul Riquet, Toulouse, France

    Background/Purpose Anti-TNFs have greatly contributed to improve RA prognosis. Hence, the needs for orthopedic surgery have considerably decreased in the past years. However, surgery, whether…
  • Abstract Number: 465 • 2014 ACR/ARHP Annual Meeting

    18-Month Worldwide Post-Marketing Surveillance Experience of Tofacitinib

    S. Cohen1, Jeffrey R. Curtis2, Roy Fleischmann1 and Y. Chen3, 1Metroplex Clinical Research Center, Dallas, TX, 2University of Alabama, Birmingham, AL, 3Pfizer Inc, Collegeville, PA

    Background/Purpose: Post-marketing surveillance is an important part of monitoring adverse events (AEs) following the approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor…
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