Abstracts tagged "safety and tocilizumab"

Abstract Number: 550 • 2017 ACR/ARHP Annual Meeting
Long-Term Safety of Tocilizumab from Large Clinical Trial and Postmarketing Populations
Shalini Mohan¹, Margaret Michalska², Jeffrey Yourish², Jinglan Pei², Sara Gale¹, Christine Birchwood² and Erhan Berber², ¹Genentech, South San Francisco, CA, ²Genentech, Inc., South San Francisco, CA
Background/Purpose: Tocilizumab (TCZ) is a recombinant humanized monoclonal antibody targeted against the interleukin-6 receptor that was approved to treat rheumatoid arthritis (RA) in the EU…
Abstract Number: 778 • 2017 ACR/ARHP Annual Meeting
Safety Events in Giant Cell Arteritis and Rheumatoid Arthritis Patient Populations
Sara Gale¹, Sophie Dimonaco², Huong Trinh¹, Katie Tuckwell², Neil Collinson², John H. Stone³, Khaled Sarsour¹, Jinglan Pei⁴, Jennifer H. Best¹, Christine Birchwood⁴ and Shalini Mohan¹, ¹Genentech, South San Francisco, CA, ²Roche Products, Ltd., Welwyn Garden City, United Kingdom, ³Massachusetts General Hospital Rheumatology Unit, Harvard Medical School, Boston, MA, ⁴Genentech, Inc., South San Francisco, CA
Background/Purpose: Recent clinical trial findings have shown efficacy for tocilizumab (TCZ) in treating giant cell arteritis (GCA).1,2 TCZ was approved for the treatment of GCA…
Abstract Number: 2614 • 2016 ACR/ARHP Annual Meeting
Similar Rates of Death, Serious Infections, Cancers, Major Cardiovascular Events in Patients Treated with Abatacept, Rituximab and Tocilizumab: Long-Term Registry Data in 4498 Patients with Rheumatoid Arthritis
Jacques-Eric Gottenberg¹, Jacques Morel^2,3, Arnaud Constantin⁴, Thomas Bardin⁵, Alain Cantagrel^6,7, Bernard Combe⁸, Maxime Dougados^9,10, Rene-Marc Flipo¹¹, Alain Saraux¹², Thierry Schaeverbeke¹³, Jean Sibilia¹⁴, Martin Soubrier¹⁵, Olivier Vittecoq¹⁶, Elodie Perrodeau¹⁷, Philippe Ravaud¹⁸, Xavier Mariette¹⁹ and on behalf of the French Society of Rheumatology and of all the investigators participating to the AIR, ORA and REGATE registries, ¹Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ²Rheumatology, Department of Rheumatology, Montpellier University Hospital, Montpellier, France, ³Immuno-Rheumatology, University Hospital of Lapeyronie, University Montpellier 1, Montpellier, France, ⁴Rheumatology, CHU Purpan - Hopital Pierre-Paul Riquet, Toulouse, France, ⁵Service de Rhumatologie. Centre Viggo Petersen. Hôpital Lariboisière, Paris, France, ⁶Rheumatology, INSERM CNRS UMR 1043, Paul Sabatier University Toulouse, Purpan Teaching Hospital, Toulouse, France, ⁷Rheumatology, Purpan University Hospital, Toulouse Cedex 9, France, ⁸Département Rhumatologie, Hôpital Lapeyronie, Montpellier, France, ⁹Rheumatology, Paris Descartes University, Paris, France, ¹⁰René Descartes University and Hôpital Cochin, Paris, France, ¹¹Rheumatology, Hopital R Salengro CHRU, Lille, France, ¹²Rheumatology, Brest University Hospital, Brest, France, ¹³Rheumatology, CHU Bordeaux, Bordeaux, France, ¹⁴Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ¹⁵Rheumatology, Department of Rheumatology, CHU Gabriel Montpied, Clermont-Ferrand, France, ¹⁶Rheumatology, Rouen University Hospital &INSERM U905, Rouen, France, ¹⁷Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, ¹⁸Epidemiology, Hotel Dieu, PARIS, France, ¹⁹Rheumatology, Rheumatology department, Bicetre Hospital, Paris-Sud University, Le Kremlin Bicetre, France
Background/Purpose: Assessment of safety in randomized controlled trials is limited by trial durations, and selection of patients with few or now comorbidities. Such limitations can…
Abstract Number: 1487 • 2015 ACR/ARHP Annual Meeting
Tocilizumab in Combination with Methotrexate in the Treatment of Rheumatoid Arthritis in Patients Who Have Failed to Disease-Modifying Antirheumatic Drugs: Long Term Results of the Brazilian Cohort
Wiliam Chahade¹, Cristiano Zerbini², Sebastiao Radominski³, Morton Scheinberg⁴, Walber P. Vieira⁵ and Ana Paula Garcia Lucco⁶, ¹Director-Rheumatology, Hospital Servidor Estadual, Sao Paulo, Brazil, ²Centro Paulista de Investigação Clinica, São Paulo, Brazil, ³Universidade Federal do Paraná, Curitiba, Brazil, ⁴Clinical Research, Hospital Abreu Sodre-AACD, Sao Paulo, Brazil, ⁵Hospital Geral de Fortaleza, Fortaleza, Brazil, ⁶Produtos Roche Químicos e Farmacêuticos SA, São Paulo, Brazil
Background/Purpose: Tocilizumab is a humanized monoclonal antibody that binds to IL-6 receptor, blocking its effects. The efficacy and safety of tocilizumab in rheumatoid arthritis (RA)…
Abstract Number: 457 • 2014 ACR/ARHP Annual Meeting
First Confirmation Data of Long Term Safety for Tocilizumab in Real-World Setting; 3 Year Follow-up Postmarketing Surveillance of 5573 Patients with Rheumatoid Arthritis in Japan
Kazuhiko Yamamoto¹, Hajime Goto², Kenzo Hirao³, Atsuo Nakajima⁴, Hideki Origasa⁵, Nobuhiro Takagi⁶, Minako Tomobe⁷ and Kyoichi Totsuka⁸, ¹Allergy & Rheumatology, Univ Tokyo Gr School of Med, Tokyo, Japan, ²Fukujuji Hospital, Tokyo, Japan, ³Heart Rhythm Center, Tokyo Medical and Dental University, Tokyo, Japan, ⁴Department of Rheumatology, Tokyo Metropolitan Police Hospital, Tokyo, Japan, ⁵Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine, Toyama, Toyama, Japan, ⁶Medical Science, Chugai Pharmaceutical, Tokyo, Japan, ⁷Pharmacovigilance, Chugai Pharmaceutical, Tokyo, Japan, ⁸Kitatama Hospital, Tokyo, Japan
Background/Purpose: To evaluate the long-term safety of tocilizumab (TCZ) for the treatment of rheumatoid arthritis (RA) in a real-world clinical setting in Japan. Methods: In…
Abstract Number: 285 • 2014 ACR/ARHP Annual Meeting
Drug Safety in Treatment of Juvenile Idiopathic Arthritis (JIA): Biologic Therapy Compared with MTX
Gerd Horneff¹, Hans Huppertz², Gerd Ganser³, Johannes Peter Haas⁴, Ivan Foeldvari⁵ and Kirsten Minden⁶, ¹Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany, ²Prof Hess Children’s Hospital, Bremen, Germany, ³Pediatric Rheumatology, Sankt Josef Stift, Sendenhorst, Germany, ⁴German Center for Pediatric and Adolescent Rheumatology, Garmisch-Partenkirchen, Germany, ⁵Department of Pediatric Rheumatology, Hamburger Zentrum für Kinder und Jugendrheumatologie, Hamburg, Germany, ⁶Epidemiology unit, German Rheumatism Research Center, Berlin, Germany
Background/Purpose Drug surveillance of biologics in juvenile patients using registries is of immense importance as patient numbers and duration in clinical trials are limited. There…
Abstract Number: 2351 • 2013 ACR/ARHP Annual Meeting
Tocilizumab In Patients With Rheumatoid Arthritis and Rates Of Malignancy: Results From Long-Term Extension Clinical Trials
Ronald F. van Vollenhoven¹, Andrea Rubbert-Roth², Anthony Sebba³, Benjamin Porter-Brown⁴, Lucy Rowell⁵, Pavel Napalkov⁶ and Devi Smart⁵, ¹Karolinska Institute, Stockholm, Sweden, ²Med Clinic I, University of Cologne, koln, Germany, ³University of South Florida, Tampa, FL, ⁴Roche Products Ltd., Welwyn Garden City, United Kingdom, ⁵Roche, Welwyn Garden City, United Kingdom, ⁶Epidemiology, Genentech, South San Francisco, CA
Background/Purpose: Malignancy is a potential risk of immunomodulatory treatments and may be increased in patients (pts) with rheumatoid arthritis (RA). The risk of malignancy was…
Abstract Number: 2352 • 2013 ACR/ARHP Annual Meeting
Evaluation and Management Of Laboratory Abnormalities During Tocilizumab Treatment Either As Monotherapy Or In Combination With Dmards In RA Patients: Findings From The ACT-STAR Study
Michael Weinblatt¹, Dennis Preston², Josh Friedman², Natasha Singh², Jenny Devenport³ and Joel M. Kremer⁴, ¹Division of Rheumatology, Brigham & Women's Hospital, Boston, MA, ²Genentech, Inc., South San Francisco, CA, ³Genentech, South San Francisco, CA, ⁴Albany Medical College and The Center for Rheumatology, Albany, NY
Background/Purpose: Laboratory values from phase III clinical trials of tocilizumab (TCZ) in patients with RA were the basis of the recommendations for monitoring and managing…
Abstract Number: 2028 • 2013 ACR/ARHP Annual Meeting
Efficacy and Safety Of Biologic Agents In Adult-Onset Still’s Disease: A Long-Term Follow-Up Of 19 Patients At a Single Referral Center
Giulio Cavalli^1,2, Stefano Franchini¹, Alvise Berti¹, Corrado Campochiaro¹, Barbara Guglielmi¹, Maria Grazia Sabbadini¹, Elena Baldissera³ and Lorenzo Dagna^4,5, ¹Internal Medicine and Clinical Immunology, Vita-Salute San Raffaele University, Milan, Italy, ²San Raffaele Scientific Institute, Milan, Italy, ³Vita-Salute San Raffaele University, Milano, Italy, ⁴Vita-Salute San Raffaele University, Milan, Italy, ⁵Medicine and Clinical Immunology, San Raffaele Scientific Institute, Milan, Italy
Background/Purpose: No data comparing the long-term outcome of Adult-Onset Still’s Disease (AOSD) patients treated with different biological drugs is currently available. We evaluated the efficacy…
Abstract Number: 1430 • 2013 ACR/ARHP Annual Meeting
Safety and Efficacy Of Subcutaneous Tocilizumab Monotherapy In a Long-Term Extension Study In Japanese Rheumatoid Arthritis Patients
Atsushi Ogata, Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine, Suita, Japan
Background/Purpose: Tocilizumab (TCZ) blocks interleukin-6-receptor signaling and is an effective rheumatoid arthritis (RA) therapy. The MUSASHI1 and SUMMACTA2 studies showed the efficacy and safety of…
Abstract Number: 459 • 2013 ACR/ARHP Annual Meeting
Transaminase Levels and Hepatic Events Observed During Tocilizumab Treatment: Pooled Analysis Of Long-Term Clinical Trial Safety Data In Patients With Rheumatoid Arthritis
MC Genovese¹, Joel M. Kremer², Ronald F. van Vollenhoven³, Rieke Alten⁴, Juan José Scali⁵, Ariella Kelman⁶, Lucy Rowell⁷ and Laura Pitts⁷, ¹Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA, ²Center for Rheumatology, Albany Medical College, Albany, NY, ³Karolinska Institute, Stockholm, Sweden, ⁴Teaching Hospital of the Charité, University of Berlin, Berlin, Germany, ⁵Durand University Hospital, Buenos Aires, Argentina, ⁶Genentech, South San Francisco, CA, ⁷Roche, Welwyn Garden City, United Kingdom
Background/Purpose: The interleukin-6 receptor inhibitor tocilizumab (TCZ) has demonstrated efficacy in improving signs/symptoms, reducing joint damage, and improving function and is well tolerated in patients…
Abstract Number: 273 • 2013 ACR/ARHP Annual Meeting
Neutropenia With Tocilizumab Treatment Is Not Associated With Increased Infection Risk In Patients With Systemic Juvenile Idiopathic Arthritis
Fabrizio De Benedetti¹, Hermine Brunner², Eileen M. Baildam³, Ruben Burgos-Vargas³, Gerd Horneff³, Hans-Iko Huppertz³, Kirsten Minden⁴, Barry L. Myones², Karen Onel⁵, Jianmei Wang⁶, Kamal N. Bharucha⁷, Daniel J. Lovell², Alberto Martini⁸ and Nicolino Ruperto³, ¹IRCCS Ospedale Pediatrico Bambino Gesú, Rome, Italy, ²PRCSG, Cincinnati, OH, ³PRINTO, Genoa, Italy, ⁴Children’s University Hospital Charite/German Rheumatism Research Centre Berlin, Berlin, Germany, ⁵Pediatric Rheumatology, University of Chicago Hospitals, Chicago, IL, ⁶Roche Products Ltd., Welwyn Garden City, United Kingdom, ⁷Genentech, South San Francisco, CA, ⁸Pediatria II, Istituto Giannina Gaslini, Genova, Italy
Background/Purpose: In the phase 3 TENDER trial of tocilizumab (TCZ) in patients with systemic juvenile idiopathic arthritis (sJIA), decreases in neutrophil count were commonly observed.…
Abstract Number: 2545 • 2012 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Tocilizumab SC Versus Tocilizumab IV, in Combination with Traditional Dmards in Patients with Moderate to Severe RA
G. R. Burmester¹, Andrea Rubbert-Roth², Alain G. Cantagrel³, Stephen Hall⁴, Piotr Leszczynski⁵, Daniel Feldman⁶, Madura J. Rangaraj⁷, Georgia Roane⁸, Charles L. Ludivico⁹, Francesco Ramirez¹⁰ and Min Bao¹¹, ¹Charité-Universitätsmedizin Berlin, Berlin, Germany, ²Klinikum der Universität zu Köln, Köln, Germany, ³Dept of Rheumatology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France, ⁴Cabrini Medical Centre, Malvern, Australia, ⁵Dept. of Rheumatology and Clinical Immunology, J. Strus Poznan Municipal Hospital, Poznan University of Medical Sciences, Poznan, Poland, ⁶Rheumatology, Universidade Federal de de São Paulo, Sao Paulo, Brazil, ⁷Arthritis & Diabetes Clinic, Inc., Monroe, LA, ⁸Rheumatology Associates of South Carolina, Charleston, SC, ⁹East Penn Rheumatology Assoc, Bethlehem, PA, ¹⁰Roche Products Limited, Welwyn, United Kingdom, ¹¹Genentech, South San Francisco, CA
Background/Purpose: The objective of this study was to compare the efficacy and safety of tocilizumab (TCZ) subcutaneous (SC) and TCZ intravenous (IV) regimen in patients…

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