Abstracts tagged "Safety issues"

Abstract Number: 2585 • 2018 ACR/ARHP Annual Meeting
Secukinumab Immunogenicity in Patients with Psoriatic Arthritis and Ankylosing Spondylitis during a 52-Week Treatment Period
Atul A. Deodhar¹, Dafna D Gladman², Iain B. McInnes³, Vibeke Strand⁴, Mengyuan Ren⁵, Sebastian Spindeldreher⁶, Luminita Pricop⁷, Brian Porter⁷, Jorge Safi⁷, Abhijit Shete⁸ and Gerard Bruin⁶, ¹Oregon Health & Science University, Portland, OR, ²Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada, ³Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom, ⁴Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ⁵Novartis Pharmaceuticals, Shanghai, China, ⁶Novartis Institutes for BioMedical Research, Basel, Switzerland, ⁷Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, East Hanover, NJ, ⁸Novartis Pharma AG, Basel, Switzerland, Basel, Switzerland
Background/Purpose: Secukinumab, a fully human monoclonal IgG1 antibody (mAb) that selectively targets IL-17A, is efficacious for the treatment of psoriasis, psoriatic arthritis (PsA) and ankylosing…
Abstract Number: 2858 • 2018 ACR/ARHP Annual Meeting
Gaps in Patient Safety Performance before Treatment with Biologic Disease-Modifying Antirheumatic Drugs or Tofacitinib in a Large Academic Healthcare System
Sarah L. Patterson¹, Michael Evans², Ishita Aggarwal³, Zara Izadi⁴, Milena Gianfrancesco⁵, Gabriela Schmajuk⁶ and Jinoos Yazdany⁷, ¹Division of Rheumatology, University of California, San Francisco, San Francisco, CA, ²University of California - San Francisco, San Francisco, CA, ³Medicine, Santa Clara Valley Medical Center, San Jose, CA, ⁴Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, ⁵Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁶San Francisco VA Medical Center, San Francisco, CA, ⁷University of California, San Francisco, San Francisco, CA
Background/Purpose: Treatment with biologic disease-modifying antirheumatic drugs (DMARDs) and tofacitinib confer increased risk of life-threatening infections, including reactivation of latent tuberculosis infection (LTBI), hepatitis B…
Abstract Number: 538 • 2017 ACR/ARHP Annual Meeting
Severe Adverse Drug Reactions Due to Disease Modifying Drugs in Patients with Incident Rheumatoid Arthritis
Lydia A Alcazar¹, Judit Font Urgelles², Cynthia Milagros León Cárdenas², Cristina Vadillo Font², Dalifer Freites Núñez¹, Leticia Leon¹, Juan A Jover Jover² and Zulema Rosales Rosado^1,2, ¹Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain, ²Rheumatology, Hospital Clínico San Carlos, Madrid, Spain
Background/Purpose: There is a well-known risk of developing adverse drug reactions (ADR) in rheumatology due, mainly, to the Disease Modifying Drugs (DMARD) used. It is…
Abstract Number: 1031 • 2017 ACR/ARHP Annual Meeting
Developing a Multi-Phase Claims-Based Algorithm to Facilitate the Study of Drug Exposure during Pregnancy
S Phillips¹, KE Johnson¹, SW Shen², KJ Woodcroft³, SA Oliveria⁴ and TA Simon⁵, ¹QuintilesIMS, Seattle, WA, ²Bristol-Myers Squibb, Hopewell, NJ, ³Henry Ford Health System, Detroit, MI, ⁴QuintilesIMS, New York, NY, ⁵Bristol-Myers Squibb, Princeton, NJ
Background/Purpose: The use of antirheumatic medications during pregnancy may lead to birth defects or other complications. Safety studies are critical, with registries being common but…
Abstract Number: 1089 • 2017 ACR/ARHP Annual Meeting
Large Variations in Tuberculosis Testing for New Biologic Users with Rheumatoid Arthritis Among Providers in the RISE Registry
Gabriela Schmajuk¹, Michael Evans², Julia Kay³ and Jinoos Yazdany⁴, ¹San Francisco VA Medical Center, University of California San Francisco, San Francisco, CA, ²University of California San Francisco, San Francisco, CA, ³Medicine/Rheumatology, University of California - San Francisco, San Francisco, CA, ⁴Medicine/Rheumatology, University of California San Francisco, San Francisco, CA
Background/Purpose: Tuberculosis (TB) testing prior to biologic DMARD use helps prevent potentially fatal, medication-related adverse events and is a National Quality Forum-endorsed quality measure. We…
Abstract Number: 1443 • 2017 ACR/ARHP Annual Meeting
Adverse Drug Reactions Due to Disease Modifying Drugs in a Cohort of Patients with Incident Rheumatoid Arthritis
Zulema Rosales Rosado^1,2, Dalifer Freites Núñez², Cristina Lajas Petisco¹, Esperanza Pato Cour¹, Leticia Leon², Judit Font Urgelles¹, Juan A Jover Jover¹ and Lydia A Alcazar², ¹Rheumatology, Hospital Clínico San Carlos, Madrid, Spain, ²Instituto de Investigación Sanitaria San Carlos (IdISSC), Madrid, Spain
Background/Purpose: There is a well-known risk of developing adverse drug reactions (ADR) in rheumatology due, mainly, to the Disease Modifying Drugs (DMARD) used. After more…
Abstract Number: 2274 • 2017 ACR/ARHP Annual Meeting
Risk of Serious Events, Serious Infections, Uveitis, Crohn’s Disease, Colitis and Malignancies in Patients with Juvenile Idiopathic Arthritis on Continuous Treatment with Etanercept over Time: A Report from a Biologics Registry
Gerd Horneff¹, Frank Weller-Heinemann², Toni Hospach³, Prasad Oommen⁴, Gerd Ganser⁵, Johannes Peter Haas⁶, K Minden⁷ and Ariane Klein⁸, ¹Asklepios Clinic, Sankt Augustin, Germany, ²PRINTO, Genoa, Italy, ³Pediatrics, Olgahospital, Klinikum Stuttgart, Stuttgard, Germany, ⁴University Duesseldorf, Duesseldorf, Germany, ⁵Pediatric Rheumatology, Sankt Josef Stift Sendenhorst, Sendenhorst, Germany, ⁶Centre for Pediatric Rheumatology Garmisch-Partenkirchen, Garmisch-Partenkirchen, Germany, ⁷Charité – University of Medicine Berlin, Berlin, Germany, ⁸Center of Pediatrics and Neonatology, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany
Background/Purpose: To investigate changes in the risk for adverse events of special interest in juvenile idiopathic arthritis (JIA) patients treated with Etanercept documented in the…
Abstract Number: 2277 • 2017 ACR/ARHP Annual Meeting
Safety of Biologic Therapies for the Treatment of Juvenile Idiopathic Arthritis: Results from the Spanish Registry of Adverse Events with Biologic Therapies (BIOBADASER)
Juan José Bethencourt Baute¹, Carlos Sánchez-Piedra², Lorena Expósito Pérez¹, M. Victoria Hernández³, Javier Manero⁴, Rosa Rosello⁵, Fernando Sánchez-Alonso⁶, Dolores Ruiz-Montesinos⁷, Eva Perez Pampín⁸, Carlos Rodriguez-Lozano⁹, Cristina Campos Fernandez¹⁰, Cristina Fernández-Carballido¹¹, Raquel Martín-Domenech¹¹, Javier Del Pino-Montes¹², Mercedes Freire¹³, Federico Díaz-González¹⁴, Juan J. Gomez-Reino¹⁵ and Sagrario Bustabad¹⁶, ¹Servicio de Reumatología, Hospital Universitario de Canarias, Tenerife, Spain, ²Research Unit, Spanish Society of Rheumatology, Madrid, Spain, ³Hospital Clinic. Barcelona. Spain, Barcelona, Spain, ⁴Rheumatology, Hospital Miguel Servet, Zaragoza, Spain, ⁵Hospital San Jorge, Huesca, Spain, ⁶Unidad de Investigación, Spanish Society of Rheumatology, Madrid, Spain, ⁷Rheumatology, Hospital Virgen Macarena, Seville, Spain, ⁸Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain, ⁹Hospital de Gran Canaria Dr. Negrín, Gran Canaria, Spain, ¹⁰Rheumatology, Hospital Universitario de Valencia., Valencia, Spain, ¹¹Hospital General Universitario de Elda, Elda, Spain, ¹²Rheumatology, HOSPITAL CLÍNICO UNIVERSITARIO DE SALAMANCA, Salamanca, Spain, ¹³Servicio de Reumatología. Instituto de Investigación Biomédica de A Coruña (INIBIC). Complexo HospitalarioUniversitario de A Coruña (CHUAC), Sergas. Universidade da Coruña (UDC), A Coruña, Spain, ¹⁴Servicio de Reumatología. Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain, ¹⁵Fundacion Ramon Dominguez, Hospital Clinico Universitario, Santiago de Compostela, Spain, ¹⁶Rheumatology, Servicio de Reumatología. Hospital Universitario de Canarias, La Laguna, Tenerife, Spain
Background/Purpose: Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in childhood. The treatment of JIA has been revolutionized by the use of…
Abstract Number: 2886 • 2017 ACR/ARHP Annual Meeting
Safety and Efficacy of Long-Time Intensified Rituximab Treatment in Patients with Systemic Sclerosis
Hans-Peter Brezinschek¹, Sonja Kielhauser², Winfried Graninger³ and Florentine Moazedi-Fürst², ¹Internal Medicine/Division of Rheumatoloy and Immunology, Rheumatology and Immunology, Medical University Graz, Austria, Graz, Austria, ²Rheumatology and Immunology, Medical University Graz, Austria, Graz, Austria, ³Rheumatology and Immunology, Medical University of Graz, Graz, Austria
Background/Purpose: Rituximab (RTX), a monoclonal B cell depleting antibody, is one of the few new drugs that has been shown to have beneficial effects on…
Abstract Number: 120 • 2017 Pediatric Rheumatology Symposium
Use Of Thalidomide From A Tertiary Level Pediatric Rheumatology Centre In India
Manjari Agarwal¹, Abhay Shivpuri² and Sujata Sawhney³, ¹Institute of Child Health, Attending Consultant, New Delhi, India, ²Division of Pediatric Rheumatology,Institute of Child Health, Post Doctoral Fellow, New Delhi, India, ³Paediatric rheumatology, Senior Consultant, New Delhi, India
Background/Purpose: Thalidomide is an effective agent for several pediatric rheumatic diseases: Systemic onset Juvenile idiopathic arthritis(SOJIA), Behcet's disease and recalcitrant skin disease in cSLE to…
Abstract Number: 1L • 2016 ACR/ARHP Annual Meeting
The Cardiovascular Safety of Celecoxib Versus Ibuprofen or Naproxen in 24,081 Patients with Osteoarthritis or Rheumatoid Arthritis
M. Elaine Husni¹, Daniel H. Solomon², Katherine E Wolski³, Lisa M Wisniewski³, Steven E Nissen⁴ and on behalf of the PRECISION Trial Investigators, ¹Rheumatology, Cleveland Clinic, Cleveland, OH, ²Division of Rheumatology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ³Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, ⁴Cardiovascular Medicine, Chair, Cleveland Clinic, Cleveland, OH

*Both authors (Husni, Solomon)　contributed equally and will co present Background/Purpose: The relative cardiovascular (CV) safety of non-selective NSAIDs and selective COX-2 NSAIDs remains unclear. Given…
Abstract Number: 2246 • 2016 ACR/ARHP Annual Meeting
Glucocorticoids in Early Rheumatoid Arthritis Management, Friend or Foe?
Diederik Decock¹, Rene Westhovens^1,2, Veerle Stouten¹, Kristien Van der Elst^2,3, Johan Joly², Patrick Verschueren^1,2 and CareRA Study Group, ¹KU Leuven Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, Leuven, Belgium, ²Rheumatology, University Hospitals Leuven, Leuven, Belgium, ³KU Leuven, Department of Public Health and Primary Care, Skeletal Biology and Engineering Research Center, Leuven, Belgium
Background/Purpose: ≥≥140/90 mmHg The only difference between treatments arms in either risk groups was a BMI decrease in Avant-Garde compared to Classic and Slim between baseline…
Abstract Number: 2440 • 2016 ACR/ARHP Annual Meeting
First Results from the Prospective German Pregnancy Register
Rebecca Fischer-Betz¹, Christina Bungartz², Jutta Richter¹, Angela Zink³, Matthias Schneider¹, Anja Weiss², Joachim Listing⁴ and Anja Strangfeld⁵, ¹Department of Rheumatology & Hiller Research Unit, Heinrich-Heine-University, Duesseldorf, Germany, ²German Rheumatism Research Centre, Berlin, Germany, ³Epidemiology Unit, German Rheumatism Research Center and Charité University Medicine, Berlin, Germany, ⁴German Rheumatism Research Center, Berlin, Germany, ⁵Epidemiology, German Rheumatism Research Center, Berlin, Germany
Background/Purpose: There is limited evidence on the safety of treatment during pregnancy and lactation. With the increasing number of new therapeutic options for inflammatory rheumatic…
Abstract Number: 2600 • 2016 ACR/ARHP Annual Meeting
Tofacitinib Is Associated with an Impaired Function of NK Cells and a Defective Immunosurveillance Against B-Cell Lymphomas
Gaetane Nocturne^1,2, Farhad Tahmasebi³, Saida Boudaoud⁴, Bineta Ly⁵ and Xavier Mariette^6,7, ¹Rheumatology Service, Bicêtre University Hospital, Le Kremlin Bicetre, France, ²INSERM U1184, Université Paris Sud, Le Kremlin Bicêtre, France, ³INSERM 1184, Paris Sud University, Le Kremlin Bicetre, France, ⁴INSERM U1184, Paris Sud University, Le Kremlin Bicêtre, France, ⁵INSERM U1184, Paris Sud University, Kremlin Bicetre, France, ⁶Department of Rheumatology, APHP - Hopitaux universitaire Paris Sud, Le Kremlin Bicetre, France, ⁷INSERM U1184, Université Paris-Sud, Paris, France, Le Kremlin Bicetre, France
Background/Purpose: Disease activity is the main risk factor for developing lymphoma in patients with rheumatoid arthritis (RA). However, the impact of immunosuppressive drugs remains an…
Abstract Number: 2630 • 2016 ACR/ARHP Annual Meeting
EBV Load Quantification in Peripheral Blood Mononuclear Cells of Patients with Rheumatoid Arthritis Treated By Abatacept and Tocilizumab
Emmanuel Massy¹, Gaétan Texier², Olivier Muis Pistor³, marielle Martin⁴, Isabelle Auger⁵, jean-Pierre Mattei⁶, Sandrine Guis⁷, Thao Pham^8,9,10, Jean Roudier^11,12,13 and Nathalie Balandraud¹⁴, ¹Rheumatology, Hôpital Sainte Marguerite, marseille, France, ²Centre d'épidémiologie et de santé publique des armées (CESPA) Marseille, marseille, France, ³rheumatology, Hôpital Sainte marguerite, marseille, France, ⁴INSERM UMRS 1097, marseille, France, ⁵Université Aix Marseille II, INSERM UMR1097, Marseille, France, ⁶Rheumatology, Hôpital Sainte Marguerite AP-HM, marseille, France, ⁷Rheumatology 1, CRMBM-CEMEREM 7339, Aix-Marseille Université, AP-HM, CNRS, Marseilles, France, ⁸Rheumatology, Service de rhumatoiogie, Marseille, France, ⁹Rheumatology Department, Sainte Marguerite Hospital, Marseille, France, ¹⁰Rheumatology, APHM, Aix Marseille University, Marseille, France, ¹¹Laboratoire d'Immunogénétique de la polyarthrite rhumatoide, INSERM UMR639, Marseille Cedex 09, France, ¹²Rheumatology 1, Aix Marseille Univ, AP-HM, INSERM, Marseille, France, ¹³Hopital Sainte Marguerite, Marseille, France, ¹⁴Rheumatology 1, AP-HM, INSERM, Marseilles, France
Background/Purpose: For twenty years, the Epstein-Barr Virus (EBV) has been suspected to contribute to Rheumatoid Arthritis (RA). Immunity against EBV is impaired in RA. RA…

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