ACR Meeting Abstracts

ACR Meeting Abstracts

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Abstracts tagged "Safety"

  • Abstract Number: 090 • 2023 Pediatric Rheumatology Symposium

    Safety Outcomes of Combined Biologics Use in Pediatric Rheumatology: A Single Center Experience

    Angela Chun1, MaiLan Nguyen1, Marietta De Guzman2 and Andrea Ramirez3, 1Baylor College of Medicine, Texas Children's Hospital, Houston, TX, 2Baylor College of Medicine, Texas Children's Hospital, Houston, TX, 3Baylor College of Medicine, Houston, TX

    Background/Purpose: The management of pediatric rheumatic disease has been forever changed by the advent of biologic drugs and the pursuit of targeted therapy. There is…
  • Abstract Number: 0190 • ACR Convergence 2021

    Long-term Safety of Canakinumab in Patients with Autoinflammatory Periodic Fever Syndromes – Interim Analysis of the RELIANCE Registry

    Jasmin Kuemmerle-Deschner1, Jorg Henes2, Birgit Kortus-Goetze3, Tilmann Kallinich4, Prasad T. Oommen5, Juergen Rech6, Frank Weller-Heinemann7, Gerd Horneff8, Ivan Foeldvari9, Aleš Janda10, Catharina Schuetz11, Frank Dressler12, Michael Borte13, Markus Hufnagel14, Axel Braner15, Florian Meier16, Michael Fiene17, Julia Weber-Arden18 and Norbert Blank19, 1Pediatric Rheumatology and Autoinflammatory Reference Center, University Children's Hospital Tuebingen, Tuebingen, Germany, 2University Hospital Tuebingen, Tuebingen, Germany, 3Division of Nephrology, University of Marburg, Marburg, Germany, 4Charité University Medicine, Nuremberg, Germany, 5Clinic of Pediatric Hematology, Oncology and Clinical Immunology, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany, 6Friedrich-Alexander University (FAU) Erlangen-Nuernberg and Universitaetsklinikum Erlangen, Department of Internal Medicine 3 - Rheumatology and Immunology, Germany, Erlangen, Germany, 7Klinikum Bremen-Mitte, Prof. Hess Kinderklinik, Bremen, Germany, 8Paediatric Rheumatology International Trials Organisation (PRINTO), Sankt Augustin, Germany, 9Hamburger Zentrum fuer Kinder- und Jugendrheumatologie, Hamburg, Germany, 10Department of Pediatrics, University Hospital Ulm, Ulm, Germany, 11Pediatrics, Medizinische Fakultaet Carl Gustav Carus, Technische Universitaet Dresden, Dresden, Germany, 12Division of Pediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany, 13ImmunoDeficiencyCenter Leipzig (IDCL), Hospital St. Georg gGmbH Leipzig, Leipzig, Germany, 14Division of Pediatric Infectious Diseases and Rheumatology, Department of Pediatrics and Adolescent Medicine, University Hospital Medical Center Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany, 15Department of Medicine II, Rheumatology, University Hospital Frankfurt, Germany, Frankfurt a.M., Germany, 161 Division of Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany 2 Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine and Pharmacology TMP, Frankfurt am Main, Germany, Frankfurt a.M., Germany, 17Department of Internal Medicine, District Hospital Demmin, Demmin, Germany, 18Novartis Pharma GmbH, Nuremberg, Germany, 19Rheumatology, University Hospital Heidelberg, Eppelheim, Germany

    Background/Purpose: Autoinflammatory periodic fever syndromes (PFS) are characterized by severe systemic and organ inflammation. In clinical trials, successful treatment was achieved with the interleukin-1β inhibitor…
  • Abstract Number: 0249 • ACR Convergence 2021

    Open-label, Long-term (10-year) Study of the Safety of Etanercept in Children with Extended Oligoarticular Arthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis

    Jelena Vojinović1, Joke Dehoorne2, Violeta Panaviene3, Gordana Susic4, Gerd Horneff5, Valda Stanevicha6, Katarzyna Kobusinska7, Zbigniew Zuber8, Bogna Dobrzyniecka9, Jonathan Akikusa10, Tadej Avcin11, Alberto Martini12, Cecilia Borlenghi13, Edmund Arthur14, Svitlana Tatulych15, Chuanbo Zang16, Bonnie Vlahos16 and Nicolino Ruperto17, 1Paediatric Rheumatology International Trials Organisation (PRINTO), Nis, Serbia, 2Paediatric Rheumatology International Trials Organisation (PRINTO), Gent, Belgium, 3Paediatric Rheumatology International Trials Organisation (PRINTO), Vilnius, Lithuania, 4Paediatric Rheumatology International Trials Organisation (PRINTO), Belgrade, Serbia, 5Paediatric Rheumatology International Trials Organisation (PRINTO), Sankt Augustin, Germany, 6Paediatric Rheumatology International Trials Organisation (PRINTO), Riga, Latvia, 7Paediatric Rheumatology International Trials Organisation (PRINTO), Bydgoszcz, Poland, 8Paediatric Rheumatology International Trials Organisation (PRINTO), Lodz, Poland, 9Paediatric Rheumatology International Trials Organisation (PRINTO), Warsaw, Poland, 10Paediatric Rheumatology International Trials Organisation (PRINTO), Melbourne, Australia, 11Paediatric Rheumatology International Trials Organisation (PRINTO), Ljubljana, Slovenia, 12Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, 13Pfizer, Buenos Aires, Argentina, Buenos Aires, Argentina, 14Pfizer, Peapack, NJ, 15Pfizer, Groton, CT, 16Pfizer, Collegeville, PA, 17IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy

    Background/Purpose: CLIPPER2 was an 8-year, open-label extension of the phase 3b, multicenter, 2-year CLIPPER study of the safety and efficacy of etanercept (ETN) in the…
  • Abstract Number: 0729 • ACR Convergence 2021

    A Multicenter, Observational, Extension Study Evaluating the Safety, Tolerability, and Efficacy of a Single Lorecivivint Injection in Knee OA Subjects

    Ismail Simsek1, Christopher Swearingen1, Heli Ghandehari1, Sarah Kennedy2, Jeyanesh Tambiah1, Yusuf Yazici3 and Nebojsa Skrepnik4, 1Biosplice Therapeutics, Inc., San Diego, CA, 2Biosplice Therapeutics, Inc, San Diego, CA, 3New York University School of Medicine, La Jolla, CA, 4Tucson Orthopaedic Institute, Tucson

    Background/Purpose: Lorecivivint (LOR), a novel intra-articular (IA) CLK/DYRK inhibitor that modulates Wnt and inflammatory pathways, is in development as a knee osteoarthritis (OA) treatment. To…
  • Abstract Number: 1302 • ACR Convergence 2021

    Year-3 Observational Follow-up of Belimumab Safety (Mortality and Malignancies) in Patients with SLE Who Completed a Phase 4, 52-Week, Randomized, Double-Blind Placebo-Controlled Safety Study

    Saira Sheikh1, Cheng-Chung Wei2, Dana Tegzova3, William Stohl4, Ricardo Acayaba de Toledo5, Tamara Mucenic6, Mauricio Abello Banfi7, Kathleen Maksimowicz-McKinnon8, Carlos Abud-Mendoza9, Sandra Navarra10, Mercedes Garcia11, Ignacio Garcia-De La Torre12, Regina Kurrasch13, Sofia Fernandes14, Julia Harris15, Saima Muzaffar14, Norma Lynn Fox13, Andrew Liu16, Holly Quasny17 and David Roth13, 1University of North Carolina Thurston Arthritis Research Center, and Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, 2Institute of Medicine, Chung Shan Medical University; Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan (Republic of China), 3Institute of Rheumatology, Prague, Czech Republic, 4University of Southern California Keck School of Medicine, Los Angeles, CA, 5Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto, Brazil, 6Hospital Moinhos de Vento, Porto Alegre, Brazil, 7Centro Integral de Reumatología del Caribe, Barranquilla, Colombia, 8Henry Ford Hospital, Wayne State University, Detroit, MI, 9Hospital Central “Dr Ignacio Morones Prieto”, Unidad Regional de Reumatología y Osteoporosis, Hospital Central and Facultad de Medicina de la Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico, 10University of Santo Tomas Hospital, Manila, Philippines, 11Hospital Interzonal General de Agudos José de San Martín, La Plata, Argentina, 12Centro de Estudios de Investigación Básica y Clínica, S.C., Guadalajara, Mexico, 13GlaxoSmithKline, Collegeville, PA, 14GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom, 15GlaxoSmithKline, Uxbridge, United Kingdom, 16GlaxoSmithKline, Brentford, United Kingdom, 17GlaxoSmithKline, Research Triangle Park, NC

    Background/Purpose: Belimumab (BEL) is a recombinant IgG1λ monoclonal antibody that is approved for treatment of systemic lupus erythematosus (SLE). Although clinical studies of BEL have…
  • Abstract Number: 1529 • ACR Convergence 2021

    Effectiveness and Safety of Pegloticase with Concomitant Immunomodulatory Therapy

    Huifeng Yun1, Brian LaMoreaux2, Lang Chen3, Stephanie Ledbetter3, Megan Francis-Sedlak2, Kenneth Saag3, Ted Mikuls4 and Jeffrey Curtis5, 1University of Alabama Birmingham, Birmingham, AL, 2Horizon Therapeutics plc, Deerfield, IL, 3University of Alabama at Birmingham, Birmingham, AL, 4University of Nebraska Medical Center, Omaha, NE, 5Division of Clinical Immunology and Rheumatology, Department of Medicine, Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: Oral urate-lowering therapy (ULT) is one of the primary treatments for gout. Unfortunately, a proportion of patients with advanced gout are resistant to oral…
  • Abstract Number: 1709 • ACR Convergence 2021

    Long-term Safety of a Single Infusion of Human Umbilical Cord Blood-derived Mesenchymal Stem Cell Therapy in Rheumatoid Arthritis: The 5-year Follow-up of the Phase I Clinical Trial

    Min Jung Kim1, Eun Hye Park2 and Kichul Shin3, 1Seoul Metropolitan Government–Seoul National University Boramae Medical Center, Seoul, Republic of Korea, 2Chung-Ang University Hospital, Seoul, Republic of Korea, 3Seoul Metropolitan Government- Seoul National University Boramae Medical Center, Seoul, Republic of Korea

    Background/Purpose: Mesenchymal stem cell (MSC) therapy represents a promise for the treatment of autoimmune diseases due to its potent immunomodulatory effect. We investigated the long-term…
  • Abstract Number: 1770 • ACR Convergence 2021

    Interim Analysis of Cohort 1 in the Mesenchymal Stromal Cell Trial in Systemic Lupus Erythematosis: Safety and Data Management During the Pandemic

    Gary Gilkeson1, Diane Kamen1, S Sam Lim2, Rosalind Ramsey-Goldman3, Kenneth Kalunian4, Saira Sheikh5, Mariko Ishimori6 and Daniel Wallace7, 1Medical University of South Carolina, Charleston, SC, 2Department of Medicine, Division of Rheumatology, Emory University School of Medicine, Atlanta, GA, 3Northwestern University, Chicago, IL, 4UC San Diego, La Jolla, CA, 5University of North Carolina Thurston Arthritis Research Center, and Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, 6Cedars-Sinai Health System, Los Angeles, CA, 7Attune Health, Beverly Hills, CA

    Background/Purpose: There is heightened interest in the use of mesenchymal stromal cells (MSCs) for the treatment of autoimmune diseases. There are a number of reports…
  • Abstract Number: 1815 • ACR Convergence 2021

    Randomised, Double-blind, Placebo-controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis

    yan li1, Kunpeng Li1, Zheng Zhao1, yanyan wang1, Jingyu Jin1, jianglin zhang1, Jian Zhu1 and feng huang2, 1First Medical Center, General Hospital of Chinese People's Liberation Army, Beijing, China (People's Republic), 2Chinese PLA General Hospital, Beijing, China (People's Republic)

    Background/Purpose: Iguratimod, also known as T-614, is a new type of small molecule compound with anti-inflammatory and immunomodulatory effects; It was listed in China(2011) and…
  • Abstract Number: 1819 • ACR Convergence 2021

    Tildrakizumab Efficacy and Safety in Patients with Psoriatic Arthritis by Metabolic Syndrome Status

    Arthur Kavanaugh1, Siba Raychaudhuri2, Christopher Ritchlin3, Akihiko Asahina4, Proton Rahman5, Fred Murphy6, Stephen Rozzo7, Siu-Long Yao7, Richard C Chou8 and Elaine Husni9, 1Division of Rheumatology, Allergy and Immunology, Department of Medicine, University of California San Diego, La Jolla, CA, 2Division of Rheumatology, Allergy & Clinical Immunology, University of California School of Medicine, Davis, Sacramento, CA, 3Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, 4Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, 5Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, 6Altoona Center for Clinical Research, Duncansville, PA, 7Sun Pharmaceutical Industries, Inc., Princeton, NJ, 8University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, Buffalo, NY, 9Cleveland Clinic, Cleveland, OH

    Background/Purpose: Metabolic syndrome (MetS) is a combination of specific risk factors for cardiovascular disease.1 The prevalence of MetS in patients (pts) with PsA has been…
  • Abstract Number: 1828 • ACR Convergence 2021

    Safety Profile of Ixekizumab for the Treatment of Psoriatic Arthritis and Axial Spondyloarthritis up to 3 Years: An Updated Integrated Safety Analysis

    Sergio Schwartzman1, Atul Deodhar2, Bernard Combe3, Ana Accioly4, Andris Kronbergs4, Boris Janos5, Danting Zhu4, David Sandoval Calderon4, Proton Rahman6 and Denis Poddubnyy7, 1Self Employed 72nd Street Medical Associates, Scarsdale, NY, 2Oregon Health & Science University, Portland, OR, 3CHU Montpellier Montpellier University, Montpellier, France, 4Eli Lilly and Company, Indianapolis, IN, 5Eli Lilly, Calgary, AB, Canada, 6Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, 7Department of Rheumatology, Charité – Universitätsmedizin, Berlin, Germany

    Background/Purpose: Ixekizumab (IXE) is a high-affinity monoclonal antibody that selectively targets IL-17A approved for the treatment of psoriasis, psoriatic arthritis (PsA), active ankylosing spondylitis (AS)…
  • Abstract Number: 1832 • ACR Convergence 2021

    Secukinumab Therapy in Biologic-naïve vs. Biologic-experienced Patients: Real-world Effectiveness, Persistence and Safety Results from the Rheumatic Diseases Portuguese Registry

    Soraia Azevedo1, Jose Tavares-Costa2, Pedro Laires3, Salomé Garcia4, Patricia Nero5, Jorge Pestana6, Joana Martins-Martinho7, Ana Bento Silva8, Joana Rodrigues9, Graca Sequeira10, Emanuel Costa11, Filipe Cunha Santos12, Carolina Furtado13, Bernardo Santos14, Ana Raposo15, Liliana Saraiva16, Beatriz Samões17, Filipe Barcelos18, Maria José Santos6 and Helena Santos19, 1Unidade Local de Saude do Alto Minho, Ponte de lima, Portugal, 2Rheumatology Department - Unidade Local de Saude do Alto Minho, Ponte de Lima, Portugal, 3Novartis Portugal / ENSP – NOVA University of Lisbon, Lisbon, Portugal, 4Rheumatology Department, Centro Hospitalar Universitário de São João EPE, Porto, Portugal, 5CUF, TELHEIRAS, Portugal, 6Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal, 7Centro Hospitalar Universitario Lisboa Norte, Lisboa, Portugal, 8Rheumatology Department, Hospital de Egas Moniz, Centro Hospitalar Lisboa Ocidental, Lisbon, Portugal, 9Rheumatology Department, ULSAM, Ponte de Lima, Portugal, 10Rheumatology Department, Centro Hospitalar Universitário do Algarve, Faro, Portugal, 11Hospital de Braga, Braga, Portugal, 12Rheumatology Department, Local Health Unit of Guarda, Guarda, Portugal, 13Rheumatology Department, Hospital do Divino Espírito Santo de Ponta Delgada, Ponta Delgada, Portugal, 14Rheumatology Department, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal, 15Centro Hospitalar de Trás-os-Montes e Alto Douro, Vila Real, Portugal, 16Rheumatology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal, 17Rheumatology Department, Centro Hospitalar Vila Nova de Gaia, Vila Nova de Gaia, Portugal, 18Instituto Português de Reumatologia, Lisbon, Portugal, 19Portuguese Institute of Rheumatology, Lisbon, Portugal

    Background/Purpose: Secukinumab has demonstrated to be efficacious for both psoriatic arthritis (PsA) and ankylosing spondylitis (AS): PASI, ACR and ASAS magnitudes of response have generally…
  • Abstract Number: L17 • 2019 ACR/ARP Annual Meeting

    Efficacy and Safety of Anifrolumab in Patients with Moderate to Severe Systemic Lupus Erythematosus: Results of the Second Phase 3 Randomized Controlled Trial

    Eric Morand1, Richard Furie 2, Yoshiya Tanaka 3, Ian Bruce 4, Anca Askanase 5, Christophe Richez 6, Sang-Cheol Bae 7, Philip Brohawn 8, Lilia Pineda 9, Anna Berglind 10 and Raj Tummala 9, 1Monash University, Melbourne, Victoria, Australia, 2Zucker School of Medicine at Hofstra/Northwell, New York, 3University of Occupational and Environmental Health, Kitakyushu, Japan, 4University of Manchester, Manchester, United Kingdom, Manchester, England, United Kingdom, 5Columbia University, New York, 6CHU de Bordeaux-GH Pellegrin, Bordeaux, France, 7Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 8Former employee of AstraZeneca, Gaithersburg, Maryland, 9AstraZeneca, Gaithersburg, Maryland, 10AstraZeneca, Gothenburg, Sweden

    Background/Purpose: Anifrolumab, a human monoclonal antibody to the type I IFN receptor subunit 1, had robust efficacy in a phase 2 study in patients with…
  • 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.…
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