Abstracts tagged "Safety"

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: 59 • 2019 ACR/ARP Annual Meeting
Evaluation of Potential Mechanisms Underlying the Safety Observations of Filgotinib in Clinical Studies in RA
Julie Di Paolo¹, Bryan Downie ², Amy Meng ³, Nevena Mollova ³, Yuanjiang Yu ³ and Pei Han ³, ¹Gilead Sciences, Foster City, CA, ²Gilead Sciences, Inc., Foster Citty, CA, ³Gilead Sciences, Inc., Foster City, CA
Background/Purpose: Inhibition of the Janus kinase-signal transducers and activators of transcription (JAK-STAT) pathway have demonstrated efficacy in immune-mediated diseases and haves been identified as therapeutic…
Abstract Number: 858 • 2019 ACR/ARP Annual Meeting
Adverse Events of Special Interest, SLE Medication Utilization, Hospitalizations, and Organ Damage: Results from a Phase 4, Randomized, Double-Blind, Placebo-Controlled, 52-week Study of Belimumab in Adults with Active, Autoantibody-Positive SLE
Saira Sheikh¹, Morton Scheinberg ², Cheng-Chung Wei ³, Dana Tegzova ⁴, William Stohl ⁵, Ricardo Acayaba de Toledo ⁶, Tamara Mucenic ⁷, Mauricio Abello Banfi ⁸, Kathleen Maksimowicz-McKinnon ⁹, Carlos Abud-Mendoza ¹⁰, Sandra Navarra ¹¹, Mercedes Garcia ¹², Ignacio Garcia-De La Torre ¹³, Josep Ordi Ros ¹⁴, Roger Abramino Levy ¹⁵, Damon L Bass ¹⁵, Jorge Ross Terrés ¹⁶, Raj Punwaney ¹⁶, Julia Harris ¹⁷, Alireza Nami ¹⁸, Amy Pierce ¹⁹, Kevin Thorneloe ²⁰, Beulah Ji ¹⁷ and David Roth ¹⁶, ¹University of North Carolina, Chapel Hill, NC, ²Centro de Pesquisas Clinicas do Hospital Abreu Sodré, São Paulo, Brazil, ³Chung Shan Medical University, Taichung City, Taiwan (Republic of China), ⁴Institute of Rheumatology, Prague, Czech Republic, ⁵University of Southern California Keck School of Medicine, Los Angeles, CA, ⁶Faculdade de Medicina de São José do Rio Preto, São Paulo, Brazil, ⁷Hospital Moinhos Angeles de Vento, Porto Alegre, Brazil, ⁸Centro Integral de Reumatología del Caribe, Barranquilla, Colombia, ⁹Henry Ford Hospital, Wayne State University, Detroit, MI, ¹⁰Hospital Central “Dr Ignacio Morones Prieto”, Unidad Regional de Reumatologia y Osteoporosis, Hospital Central and Facultad de Medicina de la Universidad Autónoma de San Luis Potosí, San Luis Potosi, Mexico, ¹¹University of Santo Tomas Hospital, Manila, Philippines, ¹²Hospital San Martín, La Plata, Argentina, ¹³Centro de Estudios de Investigación Básica y Clínica, S.C., Guadalajara, Jalisco, Mexico, ¹⁴Hospital Vall d'Hebron, Barcelona, Spain, ¹⁵GlaxoSmithKline, Collegeville, PA, ¹⁶GSK, Collegeville, PA, ¹⁷GSK, Uxbridge, Middlesex, United Kingdom, ¹⁸Joint Muscle Medical Care and Research Institute, Charlotte, NC, ¹⁹ViiV Healthcare, Research Triangle Park, NC, ²⁰GSK, Collegeville, NC
Background/Purpose: Belimumab (BEL), approved in active, autoantibody-positive SLE, has demonstrated a positive efficacy/safety profile while suggesting potential for steroid sparing and reduced organ damage accrual.…
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: 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: 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…
Abstract Number: 1624 • 2016 ACR/ARHP Annual Meeting
Safety of Surgery in Patients Treated with Tocilizumab for Rheumatoid Arthritis : Data from a French Registry
Marie Locci¹, Bernard Combe², Cédric Lukas³, Maxime Dougados⁴, Rene-Marc Flipo⁵, Christian Marcelli⁶, Stephanie Rist Bouillon⁷, Jean Sibilia⁸ and Jacques Morel⁹, ¹rheumatology, CHU Lapeyronie, MONTPELLIER, France, ²Département Rhumatologie, Hôpital Lapeyronie, Montpellier, France, ³Rheumatology, CHU Lapeyronie and EA2415, Montpellier University, University of Montpellier, France, ⁴Rheumatology, Paris Descartes University, Paris, France, ⁵Rheumatology, University Hospital, Lille, France, ⁶Rheumatology dept, University Hospital Centre of Caen, Caen, France, ⁷Rhumatologie, Hopital La Source, La Source, France, ⁸Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ⁹Rheumatology, Department of Rheumatology, Montpellier University Hospital, Montpellier, France
Background/Purpose: Rheumatoid Arthritis (RA) patients have a higher risk of post-operative complications compared with the general population, especially considering the risk of infection. It remains…
Abstract Number: 1647 • 2016 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 8 Years
Jürgen Wollenhaupt¹, Joel Silverfield², Eun Bong Lee³, Ketti Terry⁴, Kenneth Kwok⁵, Staci Abramsky⁵, Min Wang⁵, Chudy Nduaka⁶, Ryan DeMasi⁵ and Lisy Wang⁴, ¹Schoen-Klinik Hamburg-Eilbek Teaching Hospital of the University of Hamburg, Hamburg, Germany, ²Healthpoint Medical Group, Tampa, FL, ³Seoul National University, Seoul, South Korea, ⁴Pfizer Inc, Groton, CT, ⁵Pfizer Inc, New York, NY, ⁶Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. The objective of this analysis was to report tofacitinib safety and tolerability…

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