Abstracts tagged "rheumatoid arthritis (RA) and safety"

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: 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: 464 • 2014 ACR/ARHP Annual Meeting
Analysis of Pooled Data from Two Randomized Controlled Trials and Their Open-Label Extensions: Long-Term Safety in Rheumatoid Arthritis before and after Certolizumab Pegol Dose Increase/Decrease
Boulos Haraoui¹, Vivian P. Bykerk², Ronald van Vollenhoven³, Marc de Longueville⁴, Kristel Luijtens⁵, Pauline Ralston⁶ and Arthur Kavanaugh⁷, ¹Department of Medicine, Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada, ²Rheumatology, Hospital for Special Surgery, New York, NY, ³Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden, ⁴SA Global Medical Affairs, UCB Pharma, Brussels, Belgium, ⁵UCB Pharma, Brussels, Belgium, ⁶Giant Professional Ltd, London, United Kingdom, ⁷University of California San Diego, La Jolla, CA
Background/Purpose Certolizumab pegol (CZP) is approved for adult patients (pts) with rheumatic diseases (RA, PsA and AS) at a maintenance dose of 200mg every 2…
Abstract Number: 463 • 2014 ACR/ARHP Annual Meeting
Golimumab 5-Year Safety: an Analysis of Pooled Data from the Long Term Extensions of Randomized, Double-Blind, Placebo-Controlled Studies in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
Jonathan Kay¹, Roy Fleischmann², Edward C. Keystone³, Elizabeth C. Hsia^4,5, Neil Goldstein⁴, Benjamin Hsu⁴, Yiying Zhou⁴, Jürgen Braun⁶ and Arthur Kavanaugh⁷, ¹UMass Memorial Medical Center, Worcester, MA, ²Southwestern Medical Center, Department of Medicine, Metroplex Clinical Research Center, University of Texas, Dallas, TX, ³University of Toronto, Mount Sinai Hospital, Toronto, ON, Canada, ⁴Janssen Research & Development, LLC., Spring House, PA, ⁵University of Pennsylvania, Philadelphia, PA, ⁶Rheumazentrum Ruhrgebiet, Herne, Germany, ⁷University of California San Diego, La Jolla, CA
Background/Purpose: To present an analysis of pooled data through approx 5yrs of follow-up from 5 completed golimumab(GLM) Ph3 SC trials across rheumatological indications. Methods: SC…
Abstract Number: 2822 • 2014 ACR/ARHP Annual Meeting
Safety and Efficacy of Baricitinib through 128 Weeks in an Open-Label, Long-Term Extension Study in Patients with Rheumatoid Arthritis
Edward C. Keystone¹, Peter C. Taylor², Mark C Genovese³, Douglas E. Schlichting⁴, Inmaculada De La Torre⁵, Scott D. Beattie⁴ and Terence Rooney⁴, ¹University of Toronto, Mount Sinai Hospital, Toronto, ON, Canada, ²NDORMS, Botnar Research Centre, University of Oxford, Oxford, United Kingdom, ³Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵AVDA. DE LA INDUSTRIA 30, Eli Lilly and Company, Alcobendas, Spain
Background/Purpose: Baricitinib is an oral inhibitor of JAK1/JAK2 being investigated as a treatment for rheumatoid arthritis (RA). In a phase 2b study, baricitinib treatment resulted…
Abstract Number: 2516 • 2014 ACR/ARHP Annual Meeting
Reasons and Risk Factor for Discontinuation of Biologic Agents in Rheumatoid Arthritis Patients
Kenya Terabe¹, Toshihisa Kojima¹, Nobunori Takahashi^1,2, Koji Funahashi³, Atsushi Kaneko⁴, Yuji Hirano⁵, Yasuhide Kanayama⁶, Yuichiro Yabe⁷ and Naoki Ishiguro¹, ¹Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan, ²65 Tsurumai-cho, Showa-ku, Nagoya University Graduate School of Medicine, Nagoya, Japan, ³Orthopedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan, ⁴Orthopedic Surgery and Rheumatology, Nagoya Medical Center, Nagoya, Japan, ⁵Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan, ⁶Orthopedic Surgery and Rheumatology, Toyota Kosei Hospital, Toyota, Japan, ⁷Rheumatology, JCHO Tokyo Shinjuku Medical Center, Tokyo, Japan
Background/Purpose Rheumatoid arthritis (RA) patients who failed a first biologic agent due to any reasons have the option of switching to a second one along…
Abstract Number: 1487 • 2014 ACR/ARHP Annual Meeting
A Phase 1 Dose-Ranging Repeated-Dose Trial of Parenteral Staphylococcal Protein A (PRTX-100) in Patients with Active Rheumatoid Arthritis on Methotrexate or Leflunamide Therapy
Craig Wiesenhutter^1,2, Rakesh Patel³, John Lavery⁴, Nighat Tahir^5,6, Lydie Hazan⁷, Alan Kivitz⁸, Elizabeth Bretton⁹ and Jeffrey Kaine¹⁰, ¹University of Washington School of Medicine, Seattle, WA, ²Coeur d’Alene Arthritis Clinic, Coeur d’Alene, ID, ³PMG Research of Salisbury, Salisbury, NC, ⁴Allen Arthritis and Allergy, Allen, TX, ⁵Community Hospital of Anderson and Madison County, Inc., Anderson, IN, ⁶Community Rheumatology of Anderson, Anderson, IN, ⁷Axis Clinical Trials, Los Angeles, CA, ⁸Altoona Center for Clinical Research, Duncansville, PA, ⁹Albuquerque Clinical Trials, Albuquerque, NM, ¹⁰Sarasota Arthritis Center, Sarasota, FL
Background/Purpose Staphylococcal protein A (SpA) binds with high affinity to the Fc region of human immunoglobulin G and also to the Fab framework region of…
Abstract Number: 1492 • 2014 ACR/ARHP Annual Meeting
Safety and Tolerability of NNC01140006, an Anti-IL-21 Monoclonal Antibody, at Multiple s.c. Dose Levels in Patients with Rheumatoid Arthritis
Frank Wagner¹, Birte Skrumsager² and Sergey Fitilev³, ¹Charité Research Org GmbH, Berlin, Germany, ²Novo Nordisk A/S, Søborg, Denmark, ³Department of Clinical Pharmacology, Municipal Clinic #2, Moscow, Russia
Background/Purpose A phase 1, randomised, double-blind, placebo-controlled, dose-escalation trial was conducted to assess the safety and tolerability of the anti-IL-21-antibody NNC0114-0006, in patients with active…
Abstract Number: 947 • 2014 ACR/ARHP Annual Meeting
Efficacy and Safety of NNC01140006, an Anti-IL-21 Monoclonal Antibody, in Patients with Active Rheumatoid Arthritis
Juan D. Cañete¹, Piotr Leszczynski², Rikke Riisbro³ and Klaus S. Frederiksen³, ¹Arthritis Unit. Rheumatology Department, Hospital Clínic of Barcelona, Barcelona, Spain, ²Department of Rheumatology and Rehabilitation, Poznan Medical University, Poznan, Poland, ³Novo Nordisk A/S, Søborg, Denmark
Background/Purpose A phase 2, randomised, double-blind, placebo-controlled, parallel-group trial was conducted to evaluate the efficacy and safety of NNC0114-0006 in patients with active rheumatoid arthritis…
Abstract Number: 516 • 2014 ACR/ARHP Annual Meeting
The Safety and Treatment Efficacy of Abatacept in Rheumatoid Arthritis Patients with Pulmonary Complications: From the Tsurumai Biologics Communication Registry (TBCR) Multicenter Study
Shinya Hirabara¹, Toshihisa Kojima², Nobunori Takahashi², Yuji Hirano¹, Atsushi Kaneko³, Daihei Kida⁴, Yasuhide Kanayama⁵ and Naoki Ishiguro², ¹Rheumatology, Toyohashi Municipal Hospital, Toyohashi, Japan, ²Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, Nagoya, Japan, ³Orthopedic Surgery and Rheumatology, Nagoya Medical Center, Nagoya, Japan, ⁴Orthopedic Surgery and Rheumatology, Nagoya Medical Center, National Hospital Organization, Nagoya, Japan, ⁵Orthopedic Surgery and Rheumatology, Toyota Kosei Hospital, Toyota, Japan
Background/Purpose: Roughly 10-30% of rheumatoid arthritis (RA) patients reportedly develop pulmonary complications. These patients are at increased risk of MTX or biologics-induced damage, which often…
Abstract Number: 479 • 2014 ACR/ARHP Annual Meeting
Long Term Safety of Intravenous Golimumab and Comparison with Subcutaneous Golimumab in Rheumatoid Arthritis: Results through 2 Years
Rene Westhovens¹, Edward C. Keystone², Clifton O. Bingham III³, Elizabeth C. Hsia^4,5, Lilianne Kim⁴, Yiying Zhou⁴, Alan M. Mendelsohn⁶ and Michael E. Weinblatt⁷, ¹Rheumatology, University Hospital KU Leuven, Leuven, Belgium, ²Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ³Johns Hopkins University, Baltimore, MD, ⁴Janssen Research & Development, LLC., Spring House, PA, ⁵University of Pennsylvania, Philadelphia, PA, ⁶Immunology, Janssen Research & Development, LLC., Spring House, PA, ⁷Division of Rheumatology & Immunology, Brigham and Women's Hospital, Boston, MA
Long Term Safety of Intravenous Golimumab and Comparison with Subcutaneous Golimumab in Rheumatoid Arthritis: Results through 2 Years Background/Purpose: To describe the safety profile…
Abstract Number: 2378 • 2013 ACR/ARHP Annual Meeting
Safety Of Mavrilimumab In Cynomolgus Monkeys: Relevance Of Nonclinical Findings In Lung To Human Safety
Patricia C. Ryan¹, Matthew A. Sleeman², Marlon Rebelatto¹, Bing Wang³, Hong Lu⁴, Chi-Yuan Wu³, Dee Wilkins¹, Susan Spitz¹, Gopi Ranganna⁵, Alex Godwood⁶, Alex Michaels⁷, Didier Saurigny⁶, Lorin Roskos⁸, David Close⁶, Heidi Towers⁹, Kathleen McKeever¹ and Rakesh Dixit⁷, ¹Translational Sciences, MedImmune, Gaithersburg, MD, ²Respiratory, Inflammation and Autoimmunity, MedImmune Ltd, Cambridge, United Kingdom, ³Clinical Pharmacology and DMPK, Medimmune, Mountain View, CA, ⁴Translational Sciences, MedImmune, Hayward, CA, ⁵Clinical Development, MedImmune, LLC, Cambridge, United Kingdom, ⁶MedImmune, Ltd, Cambridge, United Kingdom, ⁷MedImmune, Gaithersburg, MD, ⁸One MedImmune Way, Medimmune, Gaithersburg, MD, ⁹MedImmune, LLC, Cambridge, United Kingdom
Background/Purpose: GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. Mavrilimumab (CAM-3001)…
Abstract Number: 2348 • 2013 ACR/ARHP Annual Meeting
Long Term Safety Of Intravenous Golimumab and Comparisons With Subcutaneous Golimumab In Rheumatologic Conditions: Results From The 120-Day Safety Report Of a Phase 3 Trial Of Intravenous Golimumab
Rene Westhovens¹, Clifton O. Bingham III², Michael E. Weinblatt³, Roy Fleischmann⁴, Edward C. Keystone⁵, Elizabeth C. Hsia⁶, Benjamin Hsu⁶, Lilianne Kim⁶, Surekha Mudivarthy⁶, Michael Mack⁷, Neil Goldstein⁶, Jürgen Braun⁸, Arthur Kavanaugh⁹, Alan M. Mendelsohn¹⁰ and Jonathan Kay¹¹, ¹Rheumatology, University Hospital KU Leuven, Leuven, Belgium, ²Rheumatology, Johns Hopkins University, Baltimore, MD, ³Department of Medicine, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ⁴University of Texas Southwestern Medical Center, Dallas, TX, ⁵Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁶Janssen Research & Development, LLC., Spring House, PA, ⁷Biostatistics, Janssen Research & Development, LLC., Spring House, PA, ⁸PsAID taskforce, EULAR, Zurich, Switzerland, ⁹University of California San Diego, San Diego, CA, ¹⁰Immunology, Janssen Research & Development, LLC., Spring House, PA, ¹¹UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA
Background/Purpose: To describe safety profile of IV GLM in RA from the Ph3 GLM IV program. AE rates of interest are indirectly compared to…
Abstract Number: 1732 • 2013 ACR/ARHP Annual Meeting
Efficacy and Safety Of Subcutaneous Administration Of Tabalumab, An Anti-B Cell Activating Factor Monoclonal Antibody, In Rheumatoid Arthritis: Results From a Phase 3 Multicenter, Randomized, Double-Blind Study
MC Genovese¹, Gregg J. Silverman², Paul Emery³, Ramesh Gupta⁴, Anne Gill⁵, Wendy J. Komocsar⁵, Melissa Veenhuizen⁵, Li Xie⁵, Pierre-Yves Berclaz⁵ and Chin Lee⁵, ¹Division of Rheumatology, Stanford University, Palo Alto, CA, ²Rheumatology, NYU School of Medicine, New York, NY, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ⁴Private Practice, Memphis, TN, ⁵Eli Lilly and Company, Indianapolis, IN
Background/Purpose: Tabalumab is a monoclonal antibody that neutralizes membrane-bound and soluble B cell activating factor (BAFF). These interim analyses evaluated the efficacy and safety of…

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