ACR Meeting Abstracts

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Abstracts tagged "clinical trial"

  • Abstract Number: 1338 • ACR Convergence 2021

    Bimekizumab in Patients with Psoriatic Arthritis: 3-Year Results for Overall and Tumor Necrosis Factor Inhibitor (TNFi)-Naïve Populations from a Phase 2b Open-Label Extension Study

    Philip Mease1, Atul Deodhar2, Joseph Merola3, Iain McInnes4, Deepak Assudani5, Rajan Bajracharya5, Jason Coarse6, Barbara Ink7 and Georg Schett8, 1Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, 2Oregon Health & Science University, Portland, OR, 3Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 4University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, 5UCB Pharma, Slough, United Kingdom, 6UCB Pharma, Raleigh, NC, 7UCB Celltech, Slough, UK, Slough, United Kingdom, 8Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany

    Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-­17A, and has demonstrated clinical improvements in joint and skin outcomes…
  • Abstract Number: 1687 • ACR Convergence 2021

    Integrated Laboratory Abnormality Profiles of Upadacitinib with up to 4.5 Years of Exposure in Patients with Rheumatoid Arthritis Treated in a Phase 3 Clinical Trial

    Christina Charles-Schoeman1, Jon Giles2, Nancy Lane3, Ernest Choy4, Dan Furst5, Jiri Vencovsky6, Anthony Wilson7, Gerd Burmester8, Tim Shaw9, Yanna Song10, Heidi Camp10, Nasser Khan10, Jillian Yee10, Samuel Anyanwu10 and Iain McInnes11, 1Department of Medicine, University of California, Los Angeles, Los Angeles, CA, 2Columbia University Irving Medical Center, Division of Rheumatology, New York, NY, 3University of California Davis, Hillsborough, CA, 4CREATE Centre, Cardiff University, Cardiff, Wales, United Kingdom, 5University of California Los Angeles, Los Angeles, CA, 6Institute of Rheumatology, Prague, Czech Republic, 7Center for Arthritis Research, Conway Institute, University College Dublin, Dublin, Ireland, 8Charité University Medicine Berlin, Berlin, Germany, 9AbbVie Inc., North Chicago, 10AbbVie Inc., North Chicago, IL, 11University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom

    Background/Purpose: Upadacitinib (UPA) is an oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA). The safety and efficacy of UPA has been…
  • Abstract Number: 1746 • ACR Convergence 2021

    Baricitinib Decreases Anti-dsDNA and IgG Antibodies in Adults with Systemic Lupus Erythematosus from a Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial

    Thomas Dörner1, Ronald Van Vollenhaven2, Andrea Doria3, Bochao Jia4, Damiano Fantini4, Jorge Ross Terres4, Maria Silk5, Stephanie de Bono4, Peter Fischer6 and Daniel Wallace7, 1Charite Universitätsmedizin Berlin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany, 2University Medical Center, Amsterdam, Netherlands, 3University of Padova, Padova, Italy, 4Eli Lilly and Company, Indianapolis, IN, 5Eli Lilly and Company, Carmel, IN, 6Eli Lilly and Company, North Easton, MA, 7Cedars-Sinai, Los Angeles, CA

    Background/Purpose: Baricitinib (BARI), an oral, selective Janus kinase (JAK)1 and JAK2 inhibitor, improved disease activity in adults with systemic lupus erythematosus (SLE) receiving standard background…
  • Abstract Number: 1805 • ACR Convergence 2021

    Low Rates of Radiographic Progression with 2 Years of Guselkumab (TREMFYA®), a Selective Inhibitor of the Interleukin-23p19 Subunit: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Study of Biologic-naïve Patients with Active Psoriatic Arthritis

    Philip Mease1, Alice Gottlieb2, Iain McInnes3, Proton Rahman4, Alexa Kollmeier5, Xie Xu6, Yusang Jiang6, Shihong Sheng6, May Shawi7, Soumya Chakravarty8, Frederic Lavie9 and Désirée van der Heijde10, 1Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, 2Icahn School of Medicine at Mount Sinai, New York, NY, 3University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, 4Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, 5Janssen Research & Development, LLC, La Jolla, CA, 6Janssen Research & Development, LLC, Spring House, PA, 7Janssen Immunology Global Commercial Strategy Organization, Toronto, ON, Canada, 8Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, 9Janssen Global Services, LLC, Horsham, PA, 10Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands

    Background/Purpose: Guselkumab (GUS), an IL-23p19-subunit inhibitor, is efficacious in treating patients (pts) with psoriasis and psoriatic arthritis (PsA). In the Phase 3, double-blind, placebo (PBO)-controlled…
  • Abstract Number: 0453 • ACR Convergence 2021

    Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated Results from 2 Phase 3, Randomized, Double-blind Clinical Trials for CsDMARD-IR and Bio-IR Patients

    Andrew Ostor1, Kim Papp2, Mireia Moreno3, Cathy Spargo4, Lisa Barcomb5, Ahmed M. Soliman5, Wenjing Lu6, Ann Eldred5 and Lars Erik Kristensen7, 1Monash University, Cabrini Hospital, and Emertius Research, Melbourne, Australia, 2K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada, 3Rheumatology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí, Universitat Autònoma de Barcelona, Barcelona, Spain, 4Vincent Pallotti Hospital, Johannesburg, South Africa, 5Abbvie Inc., North Chicago, IL, 6AbbVie Inc., North Chicago, 7The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Frederiksberg, Denmark

    Background/Purpose: Risankizumab (RZB) is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit. RZB is being investigated…
  • Abstract Number: 1169 • ACR Convergence 2021

    Patient Preferences for Outcome Measures for a Pragmatic Knee Osteoarthritis (OA) Clinical Trial: Results of a Cross-Sectional Patient Survey That Included Racial/Ethnic Minorities

    Jasvinder Singh, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: Many effective treatments are available for knee osteoarthritis (OA), however comparative effectiveness research (CER) of various treatments to each other is limited. One of…
  • Abstract Number: 1341 • ACR Convergence 2021

    Ixekizumab Shows a Pattern of Pain Improvement in Patients with and Without Measurable Inflammation in Psoriatic Arthritis

    Kurt de Vlam1, Gaia Gallo2, Philip Mease3, Proton Rahman4, Venkatesh Krishnan2, David Sandoval2, Chen Yen Lin2, Danting Zhu2, Rebecca Bolce2 and Philip Conaghan5, 1University Hospitals Leuven, Leuven, Belgium, 2Eli Lilly and Company, Indianapolis, IN, 3Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, 4Department of Medicine, Eastern Health and Memorial University of Newfoundland, St John's, NL, Canada, 5Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom

    Background/Purpose: The efficacy of ixekizumab (IXE) and adalimumab (ADA) in patients with psoriatic arthritis (PsA) has been previously reported using ACR 50 and Psoriasis Area…
  • Abstract Number: 1688 • ACR Convergence 2021

    Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 9.3 Years: An Updated Integrated Safety Analysis

    Peter C Taylor1, Tsutomu Takeuchi2, Gerd Burmester3, Patrick DUREZ4, Josef Smolen5, Walter Deberdt6, Jinglin Zhong7, Jorge Ross Terres6, Natalia Bello6 and Kevin Winthrop8, 1University of Oxford, Oxford, United Kingdom, 2Div. Rheumatology, Keio University, Tokyo, Japan, 3Charité University Medicine Berlin, Berlin, Germany, 4Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Brussels, Belgium, 5Medical University of Vienna, Vienna, Austria, 6Eli Lilly and Company, Indianapolis, IN, 7IQVIA, Morrisville, NC, 8Oregon Health & Science University, Portland, OR

    Background/Purpose: Baricitinib (bari) is an oral selective Janus kinase (JAK)1/JAK 2 inhibitor approved for the treatment of adult patients with moderately to severely active rheumatoid…
  • Abstract Number: 1747 • ACR Convergence 2021

    BIIB059 Demonstrates Improvement in Joint Manifestations in Participants with Systemic Lupus Erythematosus in Part a of a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study

    Ronald van Vollenhoven1, Richard Furie2, Kenneth Kalunian3, Maria Dall'Era4, Victoria Werth5, Xiaobi Huang6, Hua Carroll6, Cristina Musselli6, Catherine Barbey7 and Nathalie Franchimont6, 1Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 2Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, 3UC San Diego, La Jolla, CA, 4University of California San Francisco, Corte Madera, CA, 5Philadelphia VAMC, Philadelphia, PA, USA and Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 6Biogen, Cambridge, MA, 7Biogen, Baar, Switzerland

    Background/Purpose: Joint involvement, a frequent manifestation of SLE, can be assessed using global lupus disease activity indices (SLEDAI-2K, BILAG-2004) and/or by assessing joint tenderness and…
  • Abstract Number: 1806 • ACR Convergence 2021

    Designing a Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Guselkumab (TREMFYA®/sup>) Dosing Interval in Psoriatic Arthritis Patients with Inadequate Response to Tumor Necrosis Factor Inhibition

    Alexis Ogdie-Beatty1, Joseph Merola2, Philip Mease3, Christopher Ritchlin4, Jose Scher5, Daphne Chan6, Soumya Chakravarty7, Wayne Langholff8, Olivia Choi9, Yevgeniy Krol9, Katelyn Rowland9 and Alice Gottlieb10, 1University of Pennsylvania, Philadelphia, PA, 2Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, 3Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, 4Division of Allergy, Immunology, and Rheumatology, School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, NY, 5New York University School of Medicine, New York, NY, 6Janssen Scientific Affairs, LLC, Spring House, PA, 7Janssen Scientific Affairs, LLC and Drexel University College of Medicine, Horsham, PA, 8Janssen Research & Development, LLC, Spring House, PA, 9Janssen Scientific Affairs, LLC, Horsham, PA, 10Icahn School of Medicine at Mount Sinai, New York, NY

    Background/Purpose: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic therapy for patients (pts) with PsA, though a sizeable proportion of pts…
  • Abstract Number: 0455 • ACR Convergence 2021

    Abatacept Reverses Subclinical Arthritis in Patients with High-risk to Develop Rheumatoid Arthritis -results from the Randomized, Placebo-controlled ARIAA Study in RA-at Risk Patients

    Juergen Rech1, Mikkel Ostergaard2, Koray Tascilar3, Melanie Hagen4, Larissa Valor Mendez4, Arnd Kleyer4, Gerhard Kroenke4, David Simon5, Verena Schoenau4, Axel Hueber6, Stefan Kleinert7, Xenofon Baraliakos8, Martin Fleck9, Andrea Rubbert-Roth10, Frank Behrens11, David Kofler12, Martin Feuchtenberger13, Michael Zaenker14, Reinhard Voll15, Cornelia Glaser16, Eugen Feist17, Gerd Burmester18, Kirsten Karberg19, Johannes Strunk20, Juan D Cañete21, Esperanza Naredo22, Maria Filkova23, Ladislav Senolt24 and Georg Schett25, 1Friedrich-Alexander University (FAU) Erlangen-Nuernberg and Universitaetsklinikum Erlangen, Department of Internal Medicine 3 - Rheumatology and Immunology, Germany, Erlangen, Germany, 2Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Glostrup, Denmark, 3Friedrich Alexander University of Erlangen Nuremberg, Universitaetsklinikum Erlangen Department of Medicine-3 Rheumatology and Immunology, Erlangen, Germany, 4Friedrich-Alexander University (FAU) Erlangen-Nuernberg and Universitaetsklinikum Erlangen, Medical Department 3, Rheumatology & Immunology, Erlangen, Germany, 5Department of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nrnberg, Erlangen, Germany, 6sozialstiftung-bamberg.de, Bamberg, Germany, 7Praxisgemeinschaft Rheumatologie - Nephrologie (PGRN), Erlangen, Germany, 8Rheumazentrum Ruhrgebiet, Herne, Germany, 9Asklepios Klinikum Bad Abbach Klinik und Poliklinik für Rheumatologie/ Klin. Immunologie, Bad Abbach, Germany, 10Kantonspital St Gallen, St.Gallen, Switzerland, 11Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Frankfurt/Main, Germany, 12Division of Rheumatology and Clinical Immunology, Department I of Internal Medicine; University Hospital Cologne, Cologne, Germany, 13MED | BAYERN OST GmbH Fachbereich Rheumatologie, Burghausen, Germany, 14Immanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau, Germany, 15Department of Rheumatology and Clinical Immunology, University Medical Center, Faculty of Medicine, Albert-Ludwigs-University of Freiburg, Freiburg, Germany, 16Universitätsklinikum Freiburg Klinik für Rheumatologie und Klinische Immunologie, Freiburg, Germany, 17Helios Department of Rheumatology, Vogelsang-Gommern, Germany, 18Charité University Medicine Berlin, Berlin, Germany, 19Praxis für Rheumatologie und Innere Medizin, Berlin, Germany, 20Krankenhaus Porz am Rhein GmbH Rheumaklinik, Köln (Porz), Germany, 21Rheumatology Department, Hospital Clinic, Barcelona, Spain, 22Department of Rheumatology and Joint and Bone Research Unit, Hospital Fundación Jiménez Díaz and Autónoma University, Madrid, Spain, 23Institute of Rheumatology and Connective Tissue Research Laboratory, Department of Rheumatology of First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic, 24Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, 25Universitätsklinikum Erlangen, Department of Internal Medicine 3 – Rheumatology and Immunology, Erlangen, Germany, Erlangen, Germany

    Background/Purpose: Rheumatoid arthritis (RA) has a preclinical phase that is characterized by the presence of antibodies against citrullinated proteins (ACPA), subclinical arthritis and pain. ACPA…
  • Abstract Number: 1225 • ACR Convergence 2021

    Baseline Extracellular Matrix Biomarkers Predict Abatacept Treatment Response in MTX-Naive, ACPA+ Patients with Early RA

    Paul Emery1, Yoshiya Tanaka2, Vivian Bykerk3, Clifton Bingham4, Tom WJ Huizinga5, Gustavo Citera6, Chun Wu7, Sarah Hu7, Peter Schafer7, Jinqi Liu7, Sean Connolly7, Robert Wong8 and Roy Fleischmann9, 1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, United Kingdom, 2University of Occupational and Environmental Health, Kitakyushu, Japan, 3Division of Rheumatology, Hospital for Special Surgery, New York City, NY, 4Johns Hopkins University, Baltimore, MD, 5Leiden University Medical Center, Leiden, Netherlands, 6Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, 7Bristol Myers Squibb, Princeton, NJ, 8Bristol Myers Squibb, Basking Ridge, NJ, 9Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX

    Background/Purpose: Predictive biomarkers reflecting RA processes and treatment (tmt) efficacy are urgently needed to inform medical options. Markers of bone remodeling and extracellular matrix (ECM)…
  • Abstract Number: 1345 • ACR Convergence 2021

    Long-Term Safety and Effectiveness of Upadacitinib in Patients with Psoriatic Arthritis: Results at 56 Weeks from the SELECT-PsA 1 Study

    Iain McInnes1, Koji Kato2, Marina Magrey3, Joseph Merola4, Mitsumasa Kishimoto5, Cesar Pacheco Tena6, Derek Haaland7, Liang Chen8, Yuanyuan Duan9, Patrick Zueger10, Jianzhong Liu11, Ralph Lippe12, Aileen Pangan11 and Frank Behrens13, 1University of Glasgow, School of Medicine, Glasgow, Scotland, United Kingdom, 2AbbVie Inc, Shinagawa- Ku, Japan, 3Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH, USA, Richfield, OH, 4Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, 5Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Yokohama, Japan, 6Facultad de Medicina, Universidad Autonoma de Chihuahua, Chihuahua, Mexico, 7McMaster University, Hamilton, Ontario and The Waterside Clinic, Oro Medonte, ON, Canada, 8AbbVie Inc., North Chicago, 9AbbVie Inc, North Chicago, 10AbbVie Inc., Mettawa, IL, 11AbbVie Inc., North Chicago, IL, 12AbbVie Deutschland GmbH & Co. KG, Berlin, Germany, 13Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Fraunhofer Cluster Immune-Mediated Diseases (CIMD), Frankfurt/Main, Germany

    Background/Purpose: In the SELECT-PsA 1 study, through 24 weeks (wks), once daily upadacitinib 15 mg (UPA15) and 30 mg (UPA30) showed improvements in musculoskeletal symptoms,…
  • Abstract Number: 1691 • ACR Convergence 2021

    Long-Term Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis

    Gerd Burmester1, Stanley Cohen2, Kevin Winthrop3, Peter Nash4, Andrea Rubbert-Roth5, Atul Deodhar3, Ori Elkayam6, Eduardo Mysler7, Yoshiya Tanaka8, Jianzhong Liu9, Ana Paula Lacerda9, Bosny Pierre-Louis9, Tim Shaw10 and Philip Mease11, 1Charité University Medicine Berlin, Berlin, Germany, 2Metroplex Clinical Research Center, Dallas, TX, 3Oregon Health & Science University, Portland, OR, 4Griffith University, Brisbane, Australia, 5Kantonspital St Gallen, St.Gallen, Switzerland, 6Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, 7Organización Medica de Investigación, Rheumatology, Buenos Aires, Argentina, 8University of Occupational and Environmental Health, Kitakyushu, Japan, 9AbbVie Inc., North Chicago, IL, 10AbbVie Inc., North Chicago, 11Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA

    Background/Purpose: The efficacy and safety of the oral Janus kinase inhibitor, upadacitinib (UPA), has been evaluated for several rheumatic diseases. The objective of this analysis…
  • Abstract Number: 1748 • ACR Convergence 2021

    The Peroxisome Proliferator-Activated Receptor-γ (PPAR) Agonist Pioglitazone Improves Vascular and Metabolic Dysfunction in Patients with Systemic Lupus Erythematosus (SLE)

    Sarfaraz Hasni1, Yenealem Temesgen-Oyelakin2, Michael Davis3, Sarthak Gupta4, Elaine Poncio5, Mohammad Naqi1, Xinghao Wang6, Christopher Oliveira7, Dillon Claybaugh1, Amit Dey1, Shajia Lu1, Philip Carlucci8, Zerai Manna1, Yinghui Shi1, Isabel Ochoa5, Donald Thomas9, Theo Heller10, Massimo Gadina11, Jun Chu4, Monica Purmalek1, Xiaobai Li12, Martin Playford13, Nehal Mehta13 and Mariana Kaplan1, 1National Institutes of Health, Bethesda, MD, 2National Institutes of Health (NIH), Bethesda, MD, 3NIAMS, Bethesda, MD, 4National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), Bethesda, MD, 5NIH/NIAMS, Bethesda, MD, 6NIAMS/NIH, Bethesda, MD, 7National Institutes of Health (NIH), Vienna, VA, 8New York University School of Medicine, New York, NY, 9Arthritis and Pain Associates of Prince George's County, Silver Spring, MD, 10NIDDK/National Institutes of Health, Bethesda, MD, 11National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD, 12Clinical Center, National Institutes of Health, Bethesda, MD, 13NHLBI/National Institutes of Health, Bethesda, MD

    Background/Purpose: Premature cardiovascular events in SLE are associated with significant mortality and morbidity with no effective treatments described to date. Both immune dysregulation characteristics of…
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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.

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