Abstracts tagged "rituximab and safety"

Abstract Number: 2458 • 2018 ACR/ARHP Annual Meeting
Predictors of Hypogammaglobulinemia during Rituximab Maintenance Therapy in Rheumatoid Arthritis: A 12-Year Longitudinal Multi-Center Study
Gonçalo Boleto¹, Jérôme Avouac¹, Julien Wipff¹, Marine Forien², Maxime Dougados³, Christian Roux⁴, André Kahan¹, Philippe Dieude² and Yannick Allanore¹, ¹Université Paris Descartes, Sorbonne Paris Cité, Service de Rhumatologie A, Hôpital Cochin, Paris, France, Paris, France, ²Université Paris Diderot, Service de Rhumatologie, Hôpital Bichat, APHP, Paris, France, Paris, France, ³Department of Rheumatology, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris Descartes University, Paris, France, Paris, France, ⁴Université Paris Descartes, Sorbonne Paris Cité, INSERM U1153, Service de Rhumatologie B, Hôpital Cochin, Paris, Paris, France
Background/Purpose: Rituximab (RTX) is an anti-CD20 monoclonal antibody that selectively depletes B-cell population. Thus, it presents a potential risk for the development of hypogammaglobulinemia and…
Abstract Number: 1233 • 2018 ACR/ARHP Annual Meeting
Rituximab Safety in Patients with Rheumatoid Arthritis. an Eleven-Year Follow-up Observational Study
Raul Castellanos-Moreira Sr.¹, Sebastian C Rodriguez-Garcia¹, M. Victoria Hernández², Virginia Ruiz-Esquide³, Oscar Camacho Sr.¹, Andrea Cuervo¹, Julio Ramírez³, Juan Cañete¹, Jose Gomez Puerta¹ and Raimon Sanmarti¹, ¹Rheumatology Service, Hospital Clínic de Barcelona, Barcelona, Spain, ²Rheumatology, Hospital Clinic. Barcelona. Spain, Barcelona, Spain, ³Rheumatology, Hospital Clínic de Barcelona, Barcelona, Spain
Background/Purpose: Rituximab (RTX) is a chimeric monoclonal antibody approved for the treatment rheumatoid arthritis (RA) patients who failed to respond to tumor necrosis factor inhibitors.…
Abstract Number: 2795 • 2017 ACR/ARHP Annual Meeting
Comparison of Switching from the Originator Rituximab to the Biosimilar Rituximab GP2013 or Re‑Treatment with the Originator Rituximab in Patients with Active Rheumatoid Arthritis: Safety and Immunogenicity Results from a Multicenter, Randomized, Double-Blind Study
Hans-Peter Tony¹, Hendrik Schulze-Koops², Klaus Krüger³, Stanley B Cohen⁴, Alan J. Kivitz⁵, Slawomir Jeka⁶, Edit Vereckei⁷, Liyi Cen⁸ and Dmitrij Kollins⁸, ¹Department of Internal Medicine 2, Rheumatology and Clinical Immunology, University Hospital Würzburg, Würzburg, Germany, ²Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany, ³Praxiszentrum St. Bonifatius München, München, Germany, ⁴Metroplex Clinical Research Centre, Dallas, TX, ⁵Altoona Center for Clinical Research, Duncansville, PA, ⁶2nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, ⁷National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, ⁸Clinical Development, Sandoz, a Novartis Division, Holzkirchen, Germany
Background/Purpose: GP2013, is a biosimilar to European Union (EU) approved reference rituximab (RTX), developed in a stepwise approach that adheres to stringent biosimilar development guidelines.…
Abstract Number: 2796 • 2017 ACR/ARHP Annual Meeting
A Randomized, Double Blind Trial over 52 Weeks to Demonstrate Bioequivalence of GP2013 and Reference Rituximab in Patients with Rheumatoid Arthritis
Josef S. Smolen¹, Stanley B Cohen², Morton Scheinberg³, Tamas Shisha⁴, Dmitrij Kollins⁴, Peijuan Zhu⁵, Liyi Cen⁴, Alan J. Kivitz⁶, Andra Rodica Balanescu⁷, Juan J. Gomez-Reino⁸ and Hans-Peter Tony⁹, ¹Medical University Vienna, Division of Rheumatology, Department of Internal Medicine III, Vienna, Austria, ²Metroplex Clinical Research Centre, Dallas, TX, ³Rheumatology, Hospital Israelita Albert Einstein, Sao Paulo, Brazil, ⁴Clinical Development, Sandoz, a Novartis Division, Holzkirchen, Germany, ⁵Clinical Pharmacology, Sandoz, a Novartis Division, NJ, NJ, ⁶Altoona Center for Clinical Research, Duncansville, PA, ⁷Research Center of Rheumatic Diseases, “Sf. Maria” Hospital, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania, ⁸BIOBADASER, Santiago, Spain, Santiago de Compostela, Spain, ⁹Department of Internal Medicine 2, Rheumatology and Clinical Immunology, University Hospital Würzburg, Würzburg, Germany
Background/Purpose: Rituximab (RTX) is a mAB indicated for the treatment of RA in patients with inadequate response to anti-TNF therapy. The current study compares the…
Abstract Number: 431 • 2016 ACR/ARHP Annual Meeting
Wide Variations in Hepatitis B Screening Practices for Patients Receiving Rituximab
Gabriela Schmajuk¹, Chris Tonner², Laura Trupin³, Jing Li⁴ and Jinoos Yazdany³, ¹San Francisco VA Medical Center, University of California, San Francisco, San Francisco, CA, ²Rheumatology, University of California, San Francisco, San Francisco, CA, ³Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁴University of California, San Francisco, San Francisco, CA
Background/Purpose: Hepatitis B reactivation in the setting of rituximab use is a potentially fatal but preventable event. The rate of hepatitis B screening in patients…
Abstract Number: 2430 • 2015 ACR/ARHP Annual Meeting
Immunological Risk Factors after Rituximab Therapy in Patients with Pediatric Rheumatic Diseases – a Prospective Single-Center Study
Fabian Speth¹, Johannes Peter Haas¹ and Claas Hinze², ¹German Center for Pediatric and Adolescent Rheumatology, Garmisch-Partenkirchen, Germany, ²Department of Pediatric Rheumatology and Immunology, University Hospital Münster, Münster, Germany
Background/Purpose: Rituximab (RTX) is used in refractory pediatric rheumatic diseases (PRD). Data regarding the effects of RTX on the immune system in children and safety…
Abstract Number: 518 • 2014 ACR/ARHP Annual Meeting
Risk of Infection Associated with Subsequent Biologic Use Following Rituximab—Results from a National RA Patient Registry
Leslie R. Harrold¹, George W. Reed^1,2, Chitra Karki³, Robert Magner¹, Ashwini Shewade⁴, Ani John⁴, Joel M. Kremer⁵ and Jeffrey D. Greenberg^3,6, ¹University of Massachusetts Medical School, Worcester, MA, ²Corrona, LLC., Southborough, MA, ³Corrona, LLC, Southborough, MA, ⁴Genentech, Inc, South San Francisco, CA, ⁵Albany Medical College and The Center for Rheumatology, Albany, NY, ⁶NYU School of Medicine, New York, NY
Background/Purpose: Rituximab is a chimeric monoclonal antibody for the treatment of rheumatoid arthritis (RA). Prolonged B-cell depletion from repeated doses of rituximab may be associated…
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: 2342 • 2013 ACR/ARHP Annual Meeting
Long-Term Safety Of Rituximab: Pooled Analysis Of The Rheumatoid Arthritis Global Clinical Trial Program Over 11 Years
Ronald van Vollenhoven¹, Paul Emery^2,3, Clifton O. Bingham III⁴, Edward Keystone⁵, Roy Fleischmann⁶, Daniel Furst⁷, Eva W. Hessey⁸, Abdul Mehbob⁸ and Patricia B. Lehane⁹, ¹Karolinska Institute, Stockholm, Sweden, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ⁴Rheumatology, Johns Hopkins University, Baltimore, MD, ⁵University of Toronto, Toronto, ON, Canada, ⁶University of Texas Southwestern Medical Center, Dallas, TX, ⁷Medicine, University of California, Los Angeles, Los Angeles, CA, ⁸Roche Products Ltd., Welwyn Garden City, United Kingdom, ⁹Roche Products Ltd, Welwyn Garden City, United Kingdom
Background/Purpose: This analysis evaluated the long-term safety of rituximab (RTX) in rheumatoid arthritis (RA) patients in a global clinical trial program. Methods: Pooled observed case…
Abstract Number: 2345 • 2013 ACR/ARHP Annual Meeting
Long-Term Targeted Safety Event Rates In RA Patients Following Initiation Of Rituximab: Interim Analysis From Sunstone Registry
Kenneth G. Saag¹, Kevin L. Winthrop², Kimberly Alexander³, Steven Francom⁴ and Daniel Furst⁵, ¹Immunology & Rheumatology, The University of Alabama at Birmingham, Birmingham, AL, ²Dept of Infectious Disease, Oregon Health & Science University, Portland, OR, ³Epidemiology, Genentech, Inc., South San Francisco, CA, ⁴Genentech, Inc., South San Francisco, CA, ⁵Rheumatology, UCLA, Los Angeles, CA
Background/Purpose: Rituximab (RTX) is used for the treatment of rheumatoid arthritis (RA) in patients (pts) with an inadequate response to anti-TNF therapy (TNF-IR). Long-term safety…
Abstract Number: 1432 • 2013 ACR/ARHP Annual Meeting
The Rate Of Serious Infections Remains Stable In Patients With Multiple Retreatments In Real life : Data From The “Auto Immunity and Rituximab” (AIR) Registry
Jacques-Eric Gottenberg¹, Philippe Ravaud², Patrice Cacoub Sr.³, Thomas Bardin⁴, Alain G. Cantagrel⁵, Bernard Combe⁶, Maxime Dougados⁷, Rene-Marc Flipo⁸, Bertrand Godeau⁹, Loic Guillevin¹⁰, Xavier Le Loet¹¹, Eric Hachulla¹², Thierry Schaeverbeke¹³, Jean Sibilia¹⁴, Isabelle Pane¹⁵, Gabriel Baron¹⁶ and Xavier Mariette¹⁷, ¹Strasbourg University Hospital, Strasbourg, France, ²Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, ³Department of Internal Medicine 2., CHU Pitié-Salpêtrière, Paris, France, ⁴Rhumatology Departement, Hôpital Lariboisière, Paris, France, ⁵Rheumatology, Purpan University Hospital, Toulouse Cedex 9, France, ⁶Rheumatology, Lapeyronie Hospital, Montpellier, France, ⁷Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, ⁸Rheumatology, Hopital R Salengro CHRU, Lille, France, ⁹Internal Medicine, University of Paris, AP-HP, Hôpital Mondor Créteil, Creteil, France, ¹⁰Department of Internal Medicine,, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, ¹¹Rheumatology Department, CHU of ROUEN, Rouen, France, ¹²Department of Internal Medicine, Claude Huriez University Hospital, Lille, France, ¹³Rhumatology departement, Groupe Hospitalier Pellegrin, Bordeaux, France, ¹⁴Rhumatologie, CHU Hautepierre, Strasbourg, France, ¹⁵Hotel Dieu University Hospital Paris, Hotel Dieu University Hospital Paris, Paris, France, ¹⁶Epidemiology & Clinical Research, Groupe Hospitalier Bichat-Claude Bernard, Paris, France, ¹⁷Rheumatology Departement, Bicêtre University Hospital, Paris, France
Background/Purpose: Serious infections in patients with rheumatoid arthritis (RA) treated with rituximab (RTX) are slightly more frequent in common practice than in clinical trials. Morevover,…
Abstract Number: 877 • 2013 ACR/ARHP Annual Meeting
Results From The RATE-RA Study: A Multicenter, Single-Arm Study To Evaluate The Safety Of Administering Rituximab At a More Rapid Infusion Rate In Patients With Rheumatoid Arthritis
Charles H. Pritchard¹, Maria W. Greenwald², Joel M. Kremer³, Norman B. Gaylis⁴, William Rigby⁵, Steve Zlotnick⁶, Carol Chung⁷, Birgit Jaber⁸ and William Reiss⁹, ¹Rheumatology, Drexel University College of Medicine, Willow Grove, PA, ²Desert Medical Advances, Palm Desert, CA, ³Center for Rheumatology, Albany Medical College, Albany, NY, ⁴Arthritis & Rheumatic Disease Specialties, Aventura, FL, ⁵Department of Medicine, Geisel School of Medicine at Dartmouth, Lebanon, NH, ⁶Genentech, Inc., a Member of the Roche Group, South San Francisco, CA, ⁷Genentech Inc., South San Francisco, CA, ⁸F. Hoffmann-La Roche Ltd., Basel, Switzerland, ⁹Genentech, South San Francisco, CA
Background/Purpose: The FDA-approved dose of rituximab (RTX) in rheumatoid arthritis (RA) is 2 × 1000 mg IV infusions given 2 weeks apart (1 course), with…
Abstract Number: 502 • 2012 ACR/ARHP Annual Meeting
Safety and Efficacy of Rituximab in Patients with Rheumatoid Arthritis and Lung Involvement
Elena Becerra¹, Geraldine Cambridge² and Maria J. Leandro², ¹Rheumatology, University College London, London, United Kingdom, ²Centre for Rheumatology, Department of Medicine, University College London, London, United Kingdom
Background/Purpose: Lung involvement is common in patients with Rheumatoid Arthritis (RA), including interstitial lung disease (ILD), pleural disease and small airway disease. There are no…

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