Abstracts tagged "Safety"

Abstract Number: 894 • 2019 ACR/ARP Annual Meeting
Frequency, Severity and Costs of Flares Increase with Disease Severity in Newly Diagnosed Systematic Lupus Erythematous: A Real-World Cohort Study, United States, 2004–2015
Miao Jiang ¹, Barnabas Desta ¹, Aimee Near ², Xia Wang ¹ and Edward Hammond¹, ¹AstraZeneca, Gaithersburg, MD, ²IQVIA, Durham, NC
Background/Purpose: We evaluated the real-world frequency and severity of flares and associated costs 1 year post diagnosis in a US cohort with newly diagnosed SLE.Methods:…
Abstract Number: 1325 • 2019 ACR/ARP Annual Meeting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Japanese Subjects of the ADAMTS-5 Inhibitor S201086/GLPG1972, a Potential New Treatment in OA
Agnès Lalande ¹, Nadya Kuzniatsova-Mouchette ², Florian Chassereau ¹, Julia Geronimi ¹, Staffan Larsson ³, Andre Struglics ³, Stefan Lohmander ³ and Maria Pueyo¹, ¹Institut de Recherches Internationales Servier, Suresnes, France, Suresnes, France, ²Institut de Recherches Internationales Servier, Suresnes, France, Suresnes, ³Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden, Lund, Sweden
Background/Purpose: The disintegrin and metalloproteinase with thrombospondin motifs-5 (ADAMTS-5) is a key enzyme in OA (Verma P, et al. J Cell Biochem 2011;112:3507-14). In preclinical models…
Abstract Number: 1763 • 2019 ACR/ARP Annual Meeting
A Phase 3 Randomized Controlled Trial of Anifrolumab in Patients with Moderate to Severe Systemic Lupus Erythematosus
Richard Furie¹, Eric Morand ², Ian Bruce ³, Susan Manzi ⁴, Kenneth Kalunian ⁵, Edward Vital ⁶, Theresa Lawrence-Ford ⁷, Ramesh Gupta ⁸, Falk Hiepe ⁹, Mittermayer Santiago ¹⁰, Philip Brohawn ¹¹, Anna Berglind ¹² and Raj Tummala ¹³, ¹Zucker School of Medicine at Hofstra/Northwell, New York, NY, ²Monash University, Melbourne, Victoria, Australia, ³University of Manchester, Manchester, United Kingdom, Manchester, England, United Kingdom, ⁴Allegheny Health Network, Pittsburg, PA, ⁵Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, ⁶University of Leeds, Leeds, United Kingdom, ⁷North Georgia Rheumatology, Lawrenceville, GA, ⁸Baptist Memorial Hospital-Memphis, Memphis, TN, ⁹Charité University Hospital Berlin, Berlin, Germany, ¹⁰Bahiana School of Medicine and Public Health, Bahia, Brazil, ¹¹AstraZeneca, Gaithersburg, MD, ¹²AstraZeneca, Gothenburg, Sweden, ¹³AstraZeneca, Gaithersburg, MD, USA, Gaithersburg, MD
Background/Purpose: In a phase 2 study in SLE patients (pts), substantial efficacy was observed with anifrolumab, a human monoclonal antibody that binds the type I…
Abstract Number: 2117 • 2019 ACR/ARP Annual Meeting
Impact of Tapering Targeted Therapies (bDMARDs or Jakinibs) on the Risk of Adverse Events of Special Interest in Patients with Rheumatoid Arthritis or Spondyloarthritis: A Systematic Analysis of the Literature and Meta-analysis
DOROTHEE VINSON¹, LUC MOLLET-BENHAMOU ², Yannick Degboe ³, Thao Pham ⁴, Thomas BARNETCHE ⁵, Arnaud Constantin ⁶ and Adeline Ruyssen-Witrand ⁷, ¹AP-HM CHU Marseille, Marseille, France, ²CHU Toulouse, Toulouse, France, ³University of Glasgow, Glasgow, United Kingdom, ⁴Aix-Marseille University, CHU Marseille, department of Rheumatology, 13,000 Marseille, France, Marseille, France, ⁵CHU Bordeaux, Toulouse, France, ⁶CHU TOUOUSE, TOULOUSE, France, ⁷Rheumatology Unit, Toulouse university Hospital, UMR 1027, Inserm, Université Paul Sabatier Toulouse III, Toulouse, France
Background/Purpose: A previous meta-analysis1 showed that tapering of bDMARDs does not increase the risk of relapse in rheumatoid arthritis (RA) patients with remission or low…
Abstract Number: 2451 • 2019 ACR/ARP Annual Meeting
Rates of Myocardial Infarction, Stroke, and Revascularization Among Patients with Psoriatic Arthritis Treated with Apremilast, Biologics, DMARDs, and Corticosteroids in the US MarketScan Database
Rebecca Persson¹, Katrina Wilcox Hagberg ¹, Ellen Qian ¹, Catherine Vasilakis-Scaramozza ¹, Steve Niemcryk ², Michael Peng ², Maria Paris ², Anders Lindholm ² and Susan Jick ³, ¹Boston Collaborative Drug Surveillance Program, Lexington, ²Celgene Corporation, Summit, ³Boston Collaborative Drug Surveillance Program and Boston University School of Public Health, Boston
Background/Purpose: Patients with psoriatic arthritis (PsA) are at increased risk for cardiovascular (CV) events, but different treatment options may not have the same rates of…
Abstract Number: 2559 • 2019 ACR/ARP Annual Meeting
A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of Anifrolumab in Adults with Systemic Lupus Erythematosus
W. Winn Chatham ¹, Richard Furie ², Amit Saxena ³, Philip Brohawn ⁴, Erik Schwetje⁵, Gabriel Abreu ⁶ and Raj Tummala ⁵, ¹University of Alabama Medical Center, Birmingham, AL, ²Zucker School of Medicine at Hofstra/Northwell, New York, NY, ³NYU Langone Orthopedic Center, New York, ⁴AstraZeneca, Gaithersburg, MD, ⁵AstraZeneca, Gaithersburg, MD, USA, Gaithersburg, MD, ⁶AstraZeneca, Gothenburg, Sweden, Gothenburg, Sweden
Background/Purpose: Anifrolumab is a fully human, IgG1κ monoclonal antibody that binds to the type I IFN receptor and inhibits activity of all type I IFNs.1…
Abstract Number: 2903 • 2019 ACR/ARP Annual Meeting
Cryopyrin-Associated Periodic Syndrome Treated with Canakinumab – Long-Term Follow-up Data Documents Sustained Safety and Remission
Jasmin Kuemmerle-Deschner¹, Norbert Blank ², Michael Borte ³, Ivan Foeldvari ⁴, Gerd Horneff ⁵, Prasad Thomas Oommen ⁶, Catharina Schuetz ⁷, Frank Weller-Heinemann ⁸, Julia Weber-Arden ⁹ and Tilmann Kallinich ¹⁰, ¹University Hospital Tuebingen, Pediatric Department, Tuebingen, Germany, ²Rheumatology, University Hospital Heidelberg, Germany, Heidelberg, Germany, ³3ImmunoDeficiencyCenter Leipzig (IDCL), Hospital St. Georg gGmbH Leipzig, Germany, Leipzig, Germany, ⁴Hamburg Centre for Pediatric and Adolescence Rheumatology, Hamburg, Germany, ⁵Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, ⁶Clinic of Pediatric Hematology, Oncology and Clinical Immunology, Heinrich-Heine-University Düsseldorf, Duesseldorrf, Germany, ⁷Department of Pediatrics, Medical Faculty Carl Gustav Carus, Technical University Dresden, Dresden, Germany, Dreaden, Germany, ⁸Prof. Hess Kinderklinik, Bremen, Germany, Bremen, Germany, ⁹Novartis Pharma GmbH Germany, Nuremberg, Germany, ¹⁰Charite, Berlin, Germany
Background/Purpose: Targeting the interleukin(IL)-1 pathway with anti-IL-1 drugs is a treatment option in patients with autoinflammatory diseases like monogenic periodic fever syndromes. The study aims…
Abstract Number: 1439 • 2018 ACR/ARHP Annual Meeting
Yellow Fever Vaccination in Brazil: Short-Term Safety in Pediatric Autoimmune Rheumatic Diseases
Nadia E Aikawa¹, Verena A Balbi², Adriana C Tonacio³, Adriana M E Sallum², Lucia M A Campos², Katia T. Kozu², Margarete B Vendramini¹, Nicole Fontoura¹, Ana MC Sartori⁴, Leila Antonangelo⁵, Clovis A Silva² and Eloisa Bonfa⁶, ¹Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil, ²Pediatric Rheumatology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil, ³Infectology Division, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil, ⁴Infectology, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil, ⁵Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil, ⁶Rheumatology Division, Hospital das Clinicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
Background/Purpose: Yellow fever (YF) immunization is not routinely performed in juvenile autoimmune rheumatic disease (ARD) patients. However, during the recent epidemic campaign in state of…
Abstract Number: 495 • 2017 ACR/ARHP Annual Meeting
Efficacy of Tofacitinib in Patients with Moderate to Severe Rheumatoid Arthritis By Baseline C-Reactive Protein Levels and Erythrocyte Sedimentation Rates
Sergio Schwartzman¹, Ronald F van Vollenhoven², Alan K Matsumoto³, Dana Orange⁴, Shweta Shah⁵, Ryan DeMasi⁵, Haiyun Fan⁵, Palle Dahl⁶, Ann Wouters⁷ and Edward C. Keystone⁸, ¹Hospital for Special Surgery, New York, NY, ²Karolinska Institute, Stockholm, Sweden, ³Arthritis & Rheumatism Associates, Wheaton, MD, ⁴Rockefeller University; Hospital for Special Surgery; and New York Genome Center, New York, NY, ⁵Pfizer Inc, Collegeville, PA, ⁶Pfizer Inc, Ballerup, Denmark, ⁷Pfizer Inc, New York, NY, ⁸University of Toronto, Toronto, ON, Canada
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post-hoc analysis investigated the impact of inflammation severity at baseline (BL)…
Abstract Number: 522 • 2017 ACR/ARHP Annual Meeting
Tofacitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Rheumatoid Arthritis: Safety and Efficacy in Open-Label, Long-Term Extension Studies over 9 Years
Jürgen Wollenhaupt¹, Joel Silverfield², Eun Bong Lee³, Ketti Terry⁴, Kenneth Kwok⁵, Sander Strengholt⁶, Ryan DeMasi⁷ and Lisy Wang⁴, ¹Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ²Healthpoint Medical Group, Tampa, FL, ³Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea, Republic of (South), ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc, New York, NY, ⁶Pfizer Inc, Capelle aan den IJssel, Netherlands, ⁷Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, we report tofacitinib safety and tolerability up to 114…
Abstract Number: 2393 • 2017 ACR/ARHP Annual Meeting
Evaluation of Live Zoster Vaccine in a Subset of Patients with Rheumatoid Arthritis Treated with Tofacitinib with or without Methotrexate, and Adalimumab with Methotrexate: Results from a Phase 3b/4 Randomized Trial
Leonard H. Calabrese¹, Carlos Abud-Mendoza², Stephen Lindsey³, Sang Heon Lee⁴, Liza Takiya⁵, Noriko Iikuni⁶, Koshika Soma⁷, Zhen Luo⁸ and Roy Fleischmann⁹, ¹Cleveland Clinic Foundation, Cleveland, OH, ²Hospital Central, San Luis Potosí, Mexico, ³Ochsner Medical Center, Baton Rouge, LA, ⁴Konkuk University School of Medicine, Seoul, Korea, Republic of (South), ⁵Pfizer Inc, Collegeville, PA, ⁶Pfizer Inc, New York, NY, ⁷Pfizer Inc, Groton, CT, ⁸Pfizer Inc, Shanghai, China, ⁹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Patients (pts) with RA are at increased risk for herpes…
Abstract Number: 2481 • 2017 ACR/ARHP Annual Meeting
Long-Term Safety of Adalimumab (HUMIRA) in Adult Patients from Global Clinical Trials across Multiple Indications: An Updated Analysis in 29,987 Patients Representing 56,951 Patient-Years
Gerd R. Burmester¹, Remo Panaccione², Kenneth B. Gordon³, James T. Rosenbaum⁴, Dilek Arikan⁵, Winnie L. Lau⁵ and Rita Tarzynski-Potempa⁵, ¹Charité - University Medicine Berlin, Berlin, Germany, ²University of Calgary, Calgary, AB, Canada, ³Medical College of Wisconsin, Milwaukee, WI, ⁴Ophthalmology, Oregon Health & Science University and Legacy Devers Eye Institute, Portland, OR, ⁵AbbVie Inc., North Chicago, IL
Background/Purpose: Adalimumab is an anti–tumor necrosis factor-α (TNF-α) agent indicated for the treatment of immune-mediated diseases. The long-term safety of adalimumab was previously reported in…
Abstract Number: 2609 • 2016 ACR/ARHP Annual Meeting
The Effectiveness of Zoster Vaccine in RA Patients Subsequently Treated up to 19 Months with Tofacitinib
Kevin L Winthrop¹, Ann Wouters², Ernest H. Choy^3,4, Chudy Nduaka², Staci Abramsky², Pinaki Biswas², Lisy Wang⁵, Jennifer Hodge², Irina Lazariciu⁶, Koshika Soma², Christopher F Mojcik² and William F.C Rigby⁷, ¹Oregon Health and Sciences University, Portland, OR, ²Pfizer Inc, New York, NY, ³CREATE Center, Division of Infection and Immunity, Cardiff University School of Medicine, Cardiff, Great Britain, ⁴CREATE Center, Division of Infection and Immunity,, Cardiff University, Cardiff, United Kingdom, ⁵Pfizer Inc, Groton, CT, ⁶Quintiles, Saint-Laurent, QC, Canada, ⁷Geisel School of Medicine at Dartmouth, Lebanon, NH
Background/Purpose: Rheumatoid arthritis (RA) patients are at increased risk for herpes zoster (HZ), and vaccination is recommended in patients over the age of 50 years,…
Abstract Number: 621 • 2016 ACR/ARHP Annual Meeting
Effectiveness and Safety of CT- P13 (Biosimilar Reference Infliximab) in a Real-Life Setting in 151 Patients with Rheumatoid Arthritis and Ankylosing Spondylitis: A Mid-Term Interim Analysis
Catalin Codreanu¹, Klara Sirova², Katerina Jarosova³ and Anastas Batalov⁴, ¹Rheumatology, 'Dr. Ion Stoia' Clinical Center of Rheumatic Diseases, Bucharest, Romania, ²Revmatologie, Revmatologie MU Dr. Klara Sirova, sro, Ostrava, Czech Republic, ³Institute of Rheumatology, Prague, Czech Republic, ⁴Rheumatology, Medical University of Plovdiv, UMHAT Kaspela, Plovdiv, Bulgaria
Background/Purpose: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA) and ankylosing spondylitis (AS). However, the high…
Abstract Number: 979 • 2016 ACR/ARHP Annual Meeting
A Randomized Double-Blind Trial of Abatacept and Glucocorticoids for the Treatment of Takayasu’s Arteritis
Carol A. Langford¹, David Cuthbertson², Steven R. Ytterberg³, Nader A. Khalidi⁴, Paul A. Monach⁵, Simon Carette⁶, Philip Seo⁷, Larry W. Moreland⁸, Michael Weisman⁹, Curry L. Koening¹⁰, Antoine G. Sreih¹¹, Robert F. Spiera¹², Carol A McAlear¹³, Kenneth J. Warrington³, Christian Pagnoux¹⁴, Kathleen Maksimowicz-McKinnon¹⁵, Lindsy J. Forbess⁹, Gary S. Hoffman¹⁶, Renee Borchin¹⁷, Jeffrey Krischer¹⁷ and Peter A. Merkel¹⁸, ¹Rheumatic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, ²Biostatistics and Informatics, Department of Pediatrics, University of South Florida, Tampa, FL, ³Rheumatology, Mayo Clinic, Rochester, MN, ⁴McMaster University, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada, ⁵Rheumatology, Boston University School of Medicine, Boston, MA, ⁶Division of Rheumatology, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁷Division of Rheumatology, Johns Hopkins University, Baltimore, MD, ⁸Rheumatology & Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ⁹Rheumatology, Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁰Rheumatology, University of Utah, Salt Lake City, UT, ¹¹Department of Rheumatology, University of Pennsylvania, Philadelphia, PA, ¹²Hospital for Special Surgery, Cornell, New York, NY, ¹³Penn Vasculitis Center, Division of Rheumatology, University of Pennsylvania, Philadelphia, PA, ¹⁴Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ¹⁵Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ¹⁶Rheumatology, Cleveland Clinic, Cleveland, OH, ¹⁷University of South Florida, Tampa, FL, ¹⁸Division of Rheumatology, University of Pennsylvania, Philadelphia, PA
Background/Purpose: Takayasu’s arteritis (TAK) is a large-vessel primary systemic vasculitis that affects the aorta, its branches, and the pulmonary arteries. Despite treatment with glucocorticoids, relapse…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].