ACR Meeting Abstracts

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  • Abstract Number: 1683 • ACR Convergence 2021

    Abatacept in Usual and in Non-Specific Interstitial Pneumonia Associated to Rheumatoid Arthritis. National Multicenter Study of 190 Patients

    Belén Atienza-Mateo1, Carlos Fernández-Díaz2, Santos Castañeda3, Rafael Melero4, Francisco Ortiz-Sanjuán5, Ivette Casafont6, Sebastián C. Rodríguez-García7, Iván Ferraz-Amaro8, Miguel Ángel gonzalez-Gay9 and Ricardo Blanco10, 1Group "Research in genetic epidemiology and atherosclerosis of systemic diseases and in bone metabolic diseases of the locomotor system", IDIVAL; and Department of Rheumatology, Hospital Universitario Marqués de Valdecilla, Santander, Spain, 2Hospital Universitario Reina Sofía, Murcia, Spain, 3Hospital Universitario de la Princesa, Madrid, Spain, 4Complexo Hospitalario Universitario de Vigo, Vigo, Galicia, Spain, 5Hospital Universitario La Fe, Valencia, Spain, 6Hospital Universitari Germans Trias i Pujol, Barcelona, Badalona, Spain, 7Hospital Universitario Clinic, Barcelona, Spain, 8Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain, 9Research group on Genetic Epidemiology and Atherosclerosis in Systemic Diseases and in Metabolic Bone Diseases of the Musculoskeletal System, IDIVAL, Division of Rheumatology, Hospital Universitario Marqués de Valdecilla; School of Medicine, Universidad de Cantabria, Santander, Spain. Cardiovascular Pathophysiology and Genomics Research Unit, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa, 10Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain

    Background/Purpose: Interstitial lung disease (ILD) is a severe complication of Rheumatoid Arthritis (RA). Usual interstitial pneumonia (UIP) is considered to be more frequent and severe…
  • Abstract Number: 1686 • ACR Convergence 2021

    Efficacy and Safety of Olokizumab in a Phase III Trial of Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by TNF-α Inhibitor Therapy

    Eugen Feist1, Saeed Fatenejad2, Sergey Grishin3, Elena Korneva3, Michael Luggen4, Evgeniy Nasonov5, Mikhail Samsonov6 and Roy Fleischmann7, 1Helios Department of Rheumatology, Vogelsang-Gommern, Germany, 2SFC Medica, LLC, Charlotte, NC, 3R-Pharm, Moscow, Russia, 4Cincinnati Rheumatic Disease Study Group, Inc., and University Hospital/University of Cincinnati College of Medicine, Cincinnati, OH, 5V.A. Nasonova Reseach Institute of Rheumatology, Moscow, Russia, 6RPharm, Moscow, Russia, 7Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX

    Background/Purpose: Olokizumab (OKZ), a humanized monoclonal antibody targeting IL-6, was studied in patients with active Rheumatoid Arthritis (RA) despite methotrexate (MTX) (NCT02760368, NCT02760407) [1]. Here…
  • Abstract Number: 1685 • ACR Convergence 2021

    Efficacy and Safety of Olokizumab in a Phase III Trial of Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate – Placebo and Active Controlled Study

    Eugen Feist1, Saeed Fatenejad2, Sergey Grishin3, Elena Korneva3, Evgeniy Nasonov4, Anna Rowińska-Osuch5, Mikhail Samsonov6 and Roy Fleischmann7, 1Helios Department of Rheumatology, Vogelsang-Gommern, Germany, 2SFC Medica, LLC, Charlotte, NC, 3R-Pharm, Moscow, Russia, 4V.A. Nasonova Reseach Institute of Rheumatology, Moscow, Russia, 5MCM Polimedica, Warsaw, Poland, 6RPharm, Moscow, Russia, 7Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX

    Background/Purpose: Olokizumab (OKZ) is a humanized monoclonal antibody targeting IL-6 [1]. Here we present the results of a global phase III, head-to-head, randomized placebo (PBO)…
  • Abstract Number: 1684 • ACR Convergence 2021

    Incidence of Infections in Patients Aged ≥ 50 Years with RA and ≥ 1 Additional Cardiovascular Risk Factor: Results from a Phase 3b/4 Randomized Safety Study of Tofacitinib vs TNF Inhibitors

    Andra R Bălănescu1, Gustavo Citera2, Virginia Pascual-Ramos3, Carol A Connell4, David Gold5, All-shine Chen4, Harry Shi6, Andrea B Shapiro7, Janet Pope8 and Hendrik Schulze-Koops9, 1“Carol Davila” University of Medicine and Pharmacy, Department of Internal Medicine and Rheumatology “Sf. Maria” Hospital, Bucharest, Romania, 2Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina, 3Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico, 4Pfizer Inc, Groton, CT, 5Pfizer Inc, Montréal, QC, Canada, 6Pfizer Inc, Collegeville, PA, 7Pfizer Inc, Peapack, NJ, 8University of Western Ontario, London, ON, Canada, 9Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany

    Background/Purpose: Previous clinical trial and real-world data suggest that risk of serious infection events (SIEs) and opportunistic infections (OIs) is similar with tofacitinib 5 mg…
  • Abstract Number: 1689 • ACR Convergence 2021

    Safety, Tolerability, Pharmacokinetics, Receptor Occupancy, and Suppression of T-cell-Dependent Antibody Response in a Phase 1 Study with KPL-404, an anti-CD40 Monoclonal Antibody

    Manoj Samant1, Alistair Wheeler2, Guang-Liang Jiang1, Moses Njenga1, Madeline Spiers1, Arian Pano1 and John F Paolini1, 1Kiniksa Pharmaceuticals Corp., Lexington, MA, 2Kiniksa Pharmaceuticals, Ltd., Hamilton, Bermuda

    Background/Purpose: T-cell priming and T-cell-dependent B-cell responses require an intact cluster of differentiation (CD)40/CD40L pathway. CD40 is expressed on the surface of B-cells, dendritic cells,…
  • Abstract Number: 1692 • ACR Convergence 2021

    Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: 3-year Results from the SELECT-EARLY Study

    Ronald F van Vollenhoven1, Tsutomu Takeuchi2, Jacob Aelion3, Nilmo Chavez4, Pablo Mannucci5, Atul Singhal6, Jerzy Swierkot7, Alan Friedman8, Nasser Khan8, Yihan Li9, Xianwei Bu9, Justin Klaff8 and Vibeke Strand10, 1Amsterdam University Medical Centers, Department of Rheumatology and Clinical Immunology, Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, 2Div. Rheumatology, Keio University, Tokyo, Japan, 3Arthritis Clinic and West Tennessee Research Institute, Jackson, TN, 4Instituto Guatemalteco de Seguridad Social, Ciudad de Guatemala, Guatemala, 5Aprillus Asistencia e Investigación, Buenos Aires, Argentina, 6Southwest Rheumatology Research LLC, Dallas, TX, 7Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland, 8AbbVie Inc., North Chicago, IL, 9AbbVie Inc., North Chicago, 10Stanford University School of Medicine, Portola Valley, CA

    Background/Purpose: Upadacitinib (UPA), an oral Janus kinase inhibitor, demonstrated significant improvements in signs, symptoms, and structural inhibition as monotherapy (mono) vs methotrexate (MTX) in MTX-naïve…
  • 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: 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: 1670 • ACR Convergence 2021

    Increased Prevalence of Gastroesophageal Disease Among Patients with Rheumatoid Arthritis: A Systematic Review and Meta-analysis

    Patompong Ungprasert1, Nipith Charoenngam2, Ben Ponvilawan3, Pitchaporn Yingchoncharoen3 and Jerapas Thongpiya4, 1Cleveland Clinic, Cleveland Heights, OH, 2Mount Auburn Hospital, Boston, MA, 3Mahidol University, Bangkok, Thailand, 4Mahdiol University, Bangkok, Thailand

    Background/Purpose: Recent experimental studies have suggested that systemic inflammatory response could lead to impairment of lower esophageal function, resulting in gastroesophageal reflux disease (GERD). Epidemiologic…
  • Abstract Number: 1646 • ACR Convergence 2021

    Abnormal Cerebrovascular Biomarkers in Patients with Rheumatoid Arthritis: Results from a Prospective Study of Cognitive Aging

    Maria Vassilaki1, Cynthia Crowson2, John Davis1, Stephanie Duong1, Aivi Nguyen1, David Jones1, Michelle Mielke1, Vemuri Prashanthi1 and Elena Myasoedova1, 1Mayo Clinic, Rochester, MN, 2Mayo Clinic, Eyota, MN

    Background/Purpose: Patients with rheumatoid arthritis (RA) are at increased risk of cognitive impairment compared to the general population. This association might be due to chronic…
  • Abstract Number: 1698 • ACR Convergence 2021

    Integrated Safety Analysis Update for Filgotinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Receiving Treatment over a Median of 2.2 Years

    Kevin Winthrop1, Yoshiya Tanaka2, Tsutomu Takeuchi3, Alan Kivitz4, Mark Genovese5, Alena Pechonkina6, Franziska Matzkies6, Beatrix Bartok7, Kun Chen6, Deyuan Jiang6, Iyabode Tiamiyu6, Robin Besuyen8, Sander Strengholt9, Gerd Burmester10 and Jacques-Eric Gottenberg11, 1Oregon Health & Science University, Portland, OR, 2University of Occupational and Environmental Health, Kitakyushu, Japan, 3Div. Rheumatology, Keio University, Tokyo, Japan, 4Altoona Center for Clinical Research, Duncansville, PA, 5Gilead Sciences, Inc., Sunnyvale, CA, 6Gilead Sciences, Inc., Foster City, CA, 7Gilead Sciences, Inc., La Jolla, CA, 8Galapagos BV, Leiden, Netherlands, 9Galapagos, BV, New York, NY, 10Charité University Medicine Berlin, Berlin, Germany, 11National Reference Center for Rare East South-West Autoimmune Systemic Diseases RESO, Strasbourg University Hospitals, Strasbourg, France

    Background/Purpose: The preferential Janus kinase (JAK)-1 inhibitor filgotinib (FIL) significantly improved signs and symptoms of RA in Phase 2 and 3 trials,1–5 and FIL is…
  • Abstract Number: 1697 • ACR Convergence 2021

    Clinical Outcomes up to Week 48 of Filgotinib Treatment in an Ongoing Long-term Extension Trial of RA Patients with Inadequate Response to MTX Initially Treated with Filgotinib or Adalimumab During the Phase 3 Parent Trial

    Bernard Combe1, Yoshiya Tanaka2, Paul Emery3, Alena Pechonkina4, Albert Kuo4, Qi Gong4, Katrien Van Beneden5, Vijay Rajendran6 and Hendrik Schulze-Koops7, 1CHU Montpellier Montpellier University, Montpellier, France, 2University of Occupational and Environmental Health, Kitakyushu, Japan, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds NIHR Biomedical Research Centre, Leeds, United Kingdom, 4Gilead Sciences, Inc., Foster City, CA, 5Galapagos, NV, Mechelen, Belgium, 6Galapagos NV, Mechelen, Belgium, 7Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany

    Background/Purpose: The preferential Janus kinase (JAK)-1 inhibitor filgotinib (FIL) is approved for treatment of moderately to severely active RA in Europe and Japan. We assessed…
  • Abstract Number: 1699 • ACR Convergence 2021

    The “ITIS” Diet Improves Fatigue in Patients with Rheumatoid Arthritis and Is Associated with Changes in Metabolome and Fecal Microbiome

    Roxana Coras1, Cameron Martino1, Julia Gauglitz1, Alan Jarmusch1, Anupriya Tripathi1, Francesca Cedola2, Marta Fernandez-Bustamante1, Meritxall Agustín-Perez1, Maram Alharthi1, Susan Lee1, Abha Singh1, Soo In Choi1, Tania Rivera1, Katherine Nguyen3, Tatyana Shekhtman1, Tiffany Holt1, Shahrokh Golshan1, Rob Knight1, Pieter C Dorrestein1 and Monica Guma1, 1University of California San Diego, La Jolla, CA, 2University of California San Diego, Rome, CA, Italy, 3University of California San Diego, San Diego, CA

    Background/Purpose: Fatigue is common symptom in rheumatoid arthritis (RA), associated with decreased quality of life and productivity. Fatigue mechanisms have not been well studied, hence,…
  • Abstract Number: 1701 • ACR Convergence 2021

    Evaluation of Cardiovascular Risk Factors and Atherosclerosis in Rheumatoid Arthritis Patients, Treated with Biological Agents: 6-month Follow-up

    Georgios Papamichail1, Theodora Markatseli2, Athanasios Georgiadis3, Vasileios Xydis4, Haralampos Milionis1, Alexandros Drosos2 and Paraskevi Voulgari2, 1Internal Medicine, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece, 2Rheumatology Clinic, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece, 3Private Practice, Ioannina, Greece, Athens, Greece, 4Radiology, Department of Radiology, Medical School, University of Ioannina, Ioannina, Greece, Ioannina, Greece

    Background/Purpose: Despite new therapeutic approaches in RA, the mortality gap between RA patients and the general population persists, and may even be increasing. Cardiovascular (CV)…
  • Abstract Number: 1700 • ACR Convergence 2021

    Pharmacokinetic Boosting to Enable Once-Daily Reduced Dose Tofacitinib

    Céleste van der Togt1, Lise Verhoef2, Nathan den Broeder3, Rob ter Heine3, Bart van den Bemt4 and Alfons den Broeder5, 1Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, 2Sint Maartenskliniek, Nijmegen, Netherlands, 3Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands, 4Sint Maartenskliniek; Radboud University Medical Center, Ubbergen, Netherlands, 5Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands

    Background/Purpose: Tofacitinib is an effective, yet costly, drug for treatment of RA and PsA. Tofacitinib is metabolized mainly by the cytochrome P450-enzyme CYP3A4, and the…
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