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  • Abstract Number: 638 • 2016 ACR/ARHP Annual Meeting

    A Randomized, Open-Label, Single-Dose, Parallel-Group Trial to Determine the Pharmacokinetics, Safety and Immunogenicity of GP2017, a Proposed Adalimumab Biosimilar, Following a Single Subcutaneous Injection By an Autoinjector or Prefilled Syringe in Healthy Male Subjects

    Ellen Schuck1, Julia Jauch1, Alison Balfour1, Jennifer Storck1, Martin Rieger1, Paul Martin1, Andrej Skerjanec1 and Maria Velinova2, 1Hexal AG, Holzkirchen, Germany, 2PRA Health Sciences, Zuidlaren, Netherlands

    Background/Purpose:  The purpose of this study was to describe the pharmacokinetics (PK), safety and immunogenicity of GP2017, a proposed adalimumab biosimilar, administered as a single…
  • Abstract Number: 639 • 2016 ACR/ARHP Annual Meeting

    Switching to Biosimilars in Rheumatology: Evidence-Based Practice

    Robert J Moots1, Valderilio F Azevedo2, Thomas Dörner3, Eduardo Mysler4, Morton Scheinberg5, Javier L Coindreau6, Ehab Mahgoub7 and Lisa Marshall7, 1Department of Musculoskeletal Biology, University of Liverpool, Liverpool, United Kingdom, 2Federal University of Parana and Edumed Health Research Centerand Biotech, Curitiba, Brazil, 3Department of Medicine/Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany, 4Organización Médica de Investigación, Buenos Aires, Argentina, 5Hospital Israelita Albert Einstein, Sao Paulo, Brazil, 6edical Affairs, Pfizer, New York, NY, 7Inflammation Global Medical Affairs, Pfizer, Collegeville, PA

    Background/Purpose: Biosimilars of originator biologic therapeutics are entering the market, and health care professionals and patients need a clear understanding of these new treatments. The…
  • Abstract Number: 640 • 2016 ACR/ARHP Annual Meeting

    Clinical Responses and Synovial Vascularity in Obese Rheumatoid Arthritis Patients Treated with Adalimumab and Methotrexate

    Gurjit S. Kaeley1, Veena K. Ranganath2, Daryl K. MacCarter3, Aileen L. Pangan4, Xin Wang4 and Jasmina Kalabic5, 1University of Florida, Jacksonville, FL, 2University of California at Los Angeles, Los Angeles, CA, 3North Valley Hospital, Whitefish, MT, 4AbbVie Inc., North Chicago, IL, 5AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany

    Background/Purpose:  Obese rheumatoid arthritis (RA) patients (pts) may have higher levels of inflammatory mediators, greater joint swelling and tenderness, and suboptimal response to therapy. We…
  • Abstract Number: 641 • 2016 ACR/ARHP Annual Meeting

    Reduction of Concomitant Oral Methotrexate or Corticosteroids in Combination Treatment with Adalimumab Does Not Affect Effectiveness in Patients with Rheumatoid Arthritis

    Edward Keystone1, Ferdinand Breedveld2, Arthur Kavanaugh3, Ying Zhang4, Iain Sainsbury4 and Jasmina Kalabic5, 1Mt. Sinai Hospital, University of Toronto, Toronto, ON, Canada, 2Leiden University Medical Center, Leiden, Netherlands, 3Univ of California San Diego, San Diego, CA, 4AbbVie Inc., North Chicago, IL, 5AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany

    Background/Purpose:  In rheumatoid arthritis (RA) patients (pts) receiving corticosteroids (CS) or methotrexate (MTX) with an anti-TNF, such as adalimumab (ADA), the concomitant CS or MTX…
  • Abstract Number: 642 • 2016 ACR/ARHP Annual Meeting

    Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis

    Alan J. Kivitz1,2, James R. O'Dell3, Tsutomu Takeuchi4, Yoshiya Tanaka5, Satoshi Nakashima6, Cass Kelleher7, Jennifer Hodge8, Barbara Finck7 and RApsody Study Group, 1Altoona Center for Clinical Research, Duncansville, PA, 2Altoona Arthritis & Osteoporosis Center, Duncansville, PA, 3Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, 4Division of Rheumatology, Department of Internal Medicine,, Keio University School of Medicine, Tokyo, Japan, 5The First Department of Internal Medicine,, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 6Daiishi Sankyo, Shinagawa-Ku Tokyo, Japan, 7Clinical Science, Coherus BioSciences, Redwood City, CA, 8Coherus BioSciences, Redwood City, CA

    Background/Purpose:  CHS-0214 is in development as a proposed biosimilar of etanercept. This Phase III confirmatory, safety and efficacy study randomized and dosed 644 subjects with…
  • Abstract Number: 643 • 2016 ACR/ARHP Annual Meeting

    Exposure-Response Analyses of Efficacy of ABT-122, a Dual-Variable Domain Immunoglobulin (DVD-Ig™) Targeting TNF-α and IL-17A, Compared with Adalimumab in Subjects with Rheumatoid Arthritis and Background MTX

    Amit Khatri1, Ben Klunder2, Mukul Minocha3, Heikki T. Mansikka1 and Ahmed A. Othman1, 1AbbVie Inc., North Chicago, IL, 2AbbVie, Ludwigshafen am Rhein, Germany, 3Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL

    Background/Purpose: ABT-122 is a novel dual-variable domain immunoglobulin (DVD-IgTM), which specifically neutralizes both TNF alpha (TNFα) and interleukin-17A (IL-17). Both cytokines are expressed at increased…
  • Abstract Number: 644 • 2016 ACR/ARHP Annual Meeting

    Seroprevalence and Its Impact on Radiographic Damage in Korean Rheumatoid Arthritis Patients Starting Biologics

    Kichul Shin1, Seongjun Ha2, Inkyung Jung3, Hyoun-Ah Kim4 and Shin-Seok Lee5, 1Kyungnam villa #102, Division of Rheumatology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of, 2Division of Rheumatology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea, The Republic of, 3Department of Biostatistics, Yonsei University College of Medicine, Seoul, Korea, The Republic of, 4Ajou University Hospital, Suwon, South Korea, 5Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Korea, The Republic of

    Background/Purpose: High titers of rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibody (ACCP) are poor prognostic factors for rheumatoid arthritis (RA) patients. Only few studies…
  • Abstract Number: 645 • 2016 ACR/ARHP Annual Meeting

    Prospective Observational Real-Life Study (STRATEGE) Shows the Efficacy of Treat-to-Target Strategy and Methotrexate Monotherapy Optimization in Patients with Established Rheumatoid Arthritis

    René-Marc Flipo1, Cécile Gaujoux-Viala2, Christophe Hudry3,4, Elena Zinovieva5, Eric Leutenegger6 and Hélène Herman-Demars5, 1Rheumatology Department, Lille University Hospital Roger Salengro, Lille, France, 2Rheumatology Department, University Hospital of Nîmes and EA2415, Montpellier University, Nîmes, France, 3Rheumatology, Cochin Hospital, Paris, France, 4Rheumatology Institute, 75008, France, 5Medical Department Nordic Pharma, Paris, France, 6GECEM, Montrouge, France

    Background/Purpose: Current guidelines consider MTX as initial gold standard treatment for patients (pts) with RA. They also propose various strategies for MTX inadequate responders, among…
  • Abstract Number: 646 • 2016 ACR/ARHP Annual Meeting

    Population Pharmacokinetics of ABT-122, an Immunoglobulin Targeting Both TNF-α and IL-17A: Analyses Across Phase 1 Studies in Healthy Volunteers and Phase 2 Studies in Subjects with Rheumatoid or Psoriatic Arthritis

    Amit Khatri and Ahmed A. Othman, AbbVie Inc., North Chicago, IL

    Background/Purpose: ABT-122 is a novel dual-variable domain immunoglobulin (DVD-IgTM), which specifically neutralizes both TNF alpha (TNFα) and interleukin-17A (IL-17). Drugs individually neutralizing TNFα or IL-17…
  • Abstract Number: 647 • 2016 ACR/ARHP Annual Meeting

    Genomic and Epigenetic Bioinformatics Demonstrate Dual TNF-α and IL17A Target Engagement By ABT-122, and Suggest Mainly TNF-α–Mediated Relative Target Contribution to Drug Response in MTX-IR Rheumatoid Arthritis Patients

    Robert W. Georgantas III1, Melanie Ruzek2, Justin Wade Davis1, Feng Hong1, Elizabeth Asque1, Kenneth Idler1, Heikki T. Mansikka1, Benoit Guerette1 and Jeffrey F. Waring1, 1AbbVie Inc., North Chicago, IL, 2Immunology Discovery, AbbVie, Worcester, MA

    Background/Purpose: ABT-122 is a dual variable domain (DVD-Ig) biologic which inhibits TNF-α and IL17A. In a 12-wk phase 2 study (NCT02141997) in MTX-IR patients (pts)…
  • Abstract Number: 648 • 2016 ACR/ARHP Annual Meeting

    ABT-122, an Anti-TNF/Anti-IL-17 Dual Variable Domain Antibody, Alters T Cell Responses in Human Subjects

    Melanie Ruzek1,2, Mark Konrad2, Donna Conlon3, Kristie M. Grebe2, Anthony Slavin3, Heikki T. Mansikka4, Carolyn Cuff3 and Robert J. Padley4, 1Immunology Pharmacology, AbbVie Bioresearch Center, Worcester, MA, 2Immunology Discovery, AbbVie, Worcester, MA, 3Immunology Discovery, AbbVie Bioresearch Center, Worcester, MA, 4AbbVie Inc., North Chicago, IL

    Background/Purpose:  ABT-122 is a dual variable domain antibody which neutralizes both TNF and IL-17 and is in Phase II trials for rheumatoid arthritis (RA) and…
  • Abstract Number: 649 • 2016 ACR/ARHP Annual Meeting

    Clinical Evaluation Usefulness of Standardized Protocol Strategies of Dose Reduction in Patients with Rheumatoid Arthritis in Clinical Remission Treated with Biologic Therapies. the Optibio Study

    Carmen Bejerano1, Natividad Oreiro1, Carlos Fernandez-Lopez2, Jose A Pinto-Tasende1, Antonio Atanes1, Bruno De Aspe1, Genaro Graña Gil1, Mercedes Freire1, Manuel Acasuso3, Sonia Pertega4, Francisco J. de Toro1 and Francisco J Blanco1, 1Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruna, Spain, 2Rheumatology Division, INIBIC-Complejo Hospitalario Universitario A Coruña (CHUAC), La Coruña, Spain, 3Centro de Salud San Jose, XAP Coruna, A Coruna, Spain, 4Epidemiology Unit, INIBIC - Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

    Background/Purpose: The OPTIBIO study is a clinical trial whose primary endpoint is to evaluate the proportion of patients that after one year are maintained in…
  • Abstract Number: 650 • 2016 ACR/ARHP Annual Meeting

    ABT-122, a Tnf– and IL-17–Targeted Dual Variable Domain (DVD)–Ig™ in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Results from a Phase 2 Trial

    Mark C. Genovese1, Michael Weinblatt2, Jacob A Aelion3, Heikki T. Mansikka4, Paul M. Peloso4, Kun Chen4, Yihan Li4, Ahmed A. Othman4, Amit Khatri4, Nasser S. Khan4 and Robert J. Padley4, 1Stanford University Medical Center, Palo Alto, CA, 2Brigham and Women’s Hospital, Boston, MA, 3West Tennessee Research Institute, Jackson, TN, 4AbbVie Inc., North Chicago, IL

    Background/Purpose: Tumor necrosis factor (TNF) and interleukin 17 (IL-17) appear to independently contribute to the pathophysiology of rheumatoid arthritis (RA), synergistically inducing inflammatory mediators leading…
  • Abstract Number: 651 • 2016 ACR/ARHP Annual Meeting

    Calprotectin Serum Levels Strongly Predict Disease Flare in RA and Psa Patients with Low Disease Activity Treated with TNF Inhibitors. a One-Year Prospective Cohort Study

    Jose Inciarte-Mundo1, M. Victoria Hernández1, Virginia Ruiz-Esquide1, Sonia Cabrera-Villalba1, Julio Ramirez1, Andrea Cuervo1, Mariona Pascal2, Jordi Yagüe2, Juan D. Cañete1 and Raimon Sanmarti1, 1Rheumatology Department, Hospital Clínic de Barcelona, Barcelona, Spain, 2Immunology Department, Hospital Clinic de Barcelona, Barcelona, Spain

    Background/Purpose:  An increasing number of RA and PsA patients achieve low levels of disease activity under biological therapy. Thus, new biomarkers are needed to stratify…
  • Abstract Number: 652 • 2016 ACR/ARHP Annual Meeting

    The Reasons for Discontinuation of Combination Therapy with Methotrexate and Tumor Necrosis Factor Inhibitors Versus Triple Therapy Differ Significantly Because of Higher Adverse Events with Triple Therapy

    Daniel Erhardt1, Brian C Sauer2, Chia-Chen Teng2, Ted R. Mikuls3, Jeffrey R. Curtis4 and Grant W. Cannon2, 1Division of Rheumatology, Salt Lake City VA Medical Center and University of Utah, Salt Lake City, UT, 2Salt Lake City VA Medical Center and University of Utah, Salt Lake City, UT, 3Omaha VA Medical Center and University of Nebraska Medical Center, Omaha, NE, 4Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: We recently reported that real-world persistence in Veteran’s Affairs (VA) patients was lower in Rheumatoid arthritis (RA) patients receiving triple therapy [methotrexate (MTX), sulfasalazine…
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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.

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 CT on October 25. 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].

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