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Abstracts tagged "Adalimumab"

  • Abstract Number: 1352 • 2017 ACR/ARHP Annual Meeting

    The Relevance of Elevated CRP As an Inclusion Criterion in Clinical Trials in Patients with Rheumatoid Arthritis

    Craig Scoville1, Jessica L. Suboticki2, Sheng Zhong3 and Edward C. Keystone4, 1Idaho Falls Arthritis Clinic, Idaho Falls, ID, 2AbbVie Inc., Mettawa, IL, 3AbbVie Inc., North Chicago, IL, 4Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada

    Background/Purpose: Elevated C-reactive protein (CRP) is often used as an entry criterion in clinical trials (CT) with rheumatoid arthritis (RA) patients (pts), resulting in the…
  • Abstract Number: 2440 • 2017 ACR/ARHP Annual Meeting

    Long-Term Efficacy, Safety and Immunogenicity Results from a Randomized, Double-Blind, Phase III Confirmatory Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar, with Reference Adalimumab

    Andrew Blauvelt1, Jean-Phillipe Lacour2, Joseph Fowler3, Ellen Schuck4, Julia Jauch-Lembach4, Alison Balfour4 and Craig Leonardi5, 1Oregon Medical Research Center, Portland, OR, 2University of Nice Sophia Antipolis, Nice, France, 3Dermatology Specialists, Louisville, KY, 4Hexal AG, Holzkirchen, Germany, 5Central Dermatology, St. Louis, MO

    Background/Purpose: Based on the evaluation of physicochemical, biological, preclinical, and clinical data, a biosimilar may be approved for use in the same indications for which…
  • Abstract Number: 1418 • 2017 ACR/ARHP Annual Meeting

    The Value of Adalimumab Trough Levels and Clinical Assessments in Predicting Clinical Response in Patients with Established Rheumatoid Arthritis and an Inadequate Response to Methotrexate

    Josef S. Smolen1, Nael Mostafa2, Xin Huang2, Peter Noertersheuser3, Ben Klünder3, Kun Chen2, Jasmina Kalabic3, Iain Sainsbury2, Ruud Oerlemans4, Stefan Florentinus4 and Gerd R. Burmester5, 1Medical University Vienna, Division of Rheumatology, Department of Internal Medicine III, Vienna, Austria, 2AbbVie Inc., North Chicago, IL, 3AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, 4AbbVie, Nederland, Hoofddorp, Netherlands, 5Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany

    Background/Purpose: Low trough levels of the tumor necrosis factor inhibitor, adalimumab (ADL), and anti-ADL antibodies (AAA) were reported to be correlated with lack of response…
  • Abstract Number: 2442 • 2017 ACR/ARHP Annual Meeting

    Biosimilar Candidate BI 695501 and Adalimumab Reference Product Have Similar Efficacy and Safety in Patients with Moderately-to-Severely Active Rheumatoid Arthritis (RA): 1-Year Results from a Phase III Study

    Stanley B Cohen1, Alberto Alonso-Ruiz2, Piotr A. Klimiuk3, Eric Lee4, Nuala Peter5, Niklas Czeloth5 and Girish Jayadeva5, 1Metroplex Clinical Research Center, Dallas, TX, 2Hospital de Cruces, Barakaldo, Spain, 3Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny, Bialystok, Poland, 4Inland Rheumatology, Upland, CA, 5Boehringer Ingelheim, Ingelheim a.R., Germany

    Background/Purpose: Clinical equivalence has been shown for BI 695501 and the adalimumab reference product (RP) through similar ACR20 response at Weeks (wks) 12 and 24…
  • Abstract Number: 1419 • 2017 ACR/ARHP Annual Meeting

    Characteristics of Patients with Early Rheumatoid Arthritis Who Have a Delayed Response to Treatment with Methotrexate in Monotherapy or in Combination with Adalimumab

    Josef S. Smolen1, Xianwei Bu2, Xin Wang2, Jessica L. Suboticki3 and Arthur Kavanaugh4, 1Medical University Vienna, Division of Rheumatology, Department of Internal Medicine III, Vienna, Austria, 2AbbVie Inc., North Chicago, IL, 3AbbVie Inc., Mettawa, IL, 4Medicine, University of California, San Diego, La Jolla, CA

    Background/Purpose: In patients (pts) with rheumatoid arthritis (RA), treat-to-target recommendations call for adjustment of treatment if a target is not met within 3-6 months (mths)…
  • Abstract Number: 2443 • 2017 ACR/ARHP Annual Meeting

    Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects

    Julia Jauch-Lembach1, Andrej Skerjanec1, Halimuniyazi Haliduola1, Nicole Hass1, Oliver von Richter1, Rainard Fuhr2 and Thomas Koernicke2, 1Hexal AG, Holzkirchen, Germany, 2PAREXEL International GmbH, Berlin, Germany

    Background/Purpose: GP2017 is a proposed adalimumab biosimilar that has been shown to be similar to reference adalimumab at an analytical and preclinical level. The aim…
  • Abstract Number: 1420 • 2017 ACR/ARHP Annual Meeting

    The Ability of Patients with Early Rheumatoid Arthritis to Taper Low-Dose Glucocorticoids on Methotrexate Monotherapy and in Combination with Adalimumab

    Josef S. Smolen1, Prashanth Sunkureddi2, Jaclyn K. Anderson3, Jenny Griffith3, Dingfeng Jiang3, Kun Chen3, Jessica L. Suboticki4 and Arthur Kavanaugh5, 1Division of Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria, 2Clear Lake Rheumatology, Nassau Bay, TX, 3AbbVie Inc., North Chicago, IL, 4AbbVie Inc., Mettawa, IL, 5Medicine, University of California, San Diego, La Jolla, CA

    Background/Purpose: Low dose glucocorticoids (GCs) are recommended in combination with ≥1 synthetic DMARDs as part of the initial treatment strategy in rheumatoid arthritis (RA), with…
  • Abstract Number: 2453 • 2017 ACR/ARHP Annual Meeting

    Methotrexate Discontinuation from Combination Therapy with Adalimumab Is Not Associated with Inferior Outcomes at 6 Months

    Dimitrios A. Pappas1, Chitra Karki1, Ying Shan1, Jessica L. Suboticki2, Jenny Griffith3 and Joel Kremer4, 1Corrona, LLC, Southborough, MA, 2AbbVie Inc., Mettawa, IL, 3AbbVie Inc., North Chicago, IL, 4Albany Medical College and The Center for Rheumatology, Albany, NY

    Background/Purpose: Methotrexate is frequently administered in combination with biologics for the therapy of Rheumatoid Arthritis (RA) as it leads to superior outcomes compared to biologic…
  • Abstract Number: 1422 • 2017 ACR/ARHP Annual Meeting

    Impact of Adalimumab on Prednisone Use in Patients with Rheumatoid Arthritis in a Real World Setting – Results from the Corrona Registry

    Dimitrios A. Pappas1, Chitra Karki1, Heather J. Litman1, Taylor Blachley1, Jessica L. Suboticki2, Jenny Griffith3 and Joel Kremer4, 1Corrona, LLC, Southborough, MA, 2AbbVie Inc., Mettawa, IL, 3AbbVie Inc., North Chicago, IL, 4Albany Medical College and The Center for Rheumatology, Albany, NY

    Background/Purpose: Steroids are used to reduce inflammation and pain among rheumatoid arthritis (RA) patients, but they can cause harmful side effects, and in some patients,…
  • Abstract Number: 2495 • 2017 ACR/ARHP Annual Meeting

    Biosimilarity between Humira® and the Biosimilar Candidate SB5 in Product Quality

    Nayoung Lee, Minlee Kim, JongAh Joanne Lee, Soohwan Kim and Hahymn Yang, Samsung Bioepis, Incheon, Korea, Republic of (South)

    Background/Purpose: A biosimilar is a biopharmaceutical product that is highly similar to an already licensed one in terms of quality, safety, and efficacy. We (Samsung…
  • Abstract Number: 1424 • 2017 ACR/ARHP Annual Meeting

    Impact of Glucocorticoid Therapy on the Efficacy of SC Abatacept or Adalimumab in RA Patients with Inadequate Response to MTX: A Post Hoc Analysis of Data from a Head-to-Head Trial

    Yannick Degboé1,2, Michael Schiff3, Michael Weinblatt4, Roy Fleischmann5, HA Ahmad6 and Arnaud Constantin2,7, 1Toulouse University Hospital, Toulouse, France, 2Université Paul Sabatier, Toulouse, France, 3University of Colorado, Denver, CO, 4Brigham and Women’s Hospital, Boston, MA, 5University of Texas Southwestern Medical Center, Dallas, TX, 6Bristol-Myers Squibb, Princeton, NJ, 7Purpan University Hospital, Toulouse, France

    Background/Purpose: In patients with RA, low-dose glucocorticoids (GCs) have been shown to increase clinical, functional and radiographic efficacy when combined with conventional synthetic DMARDs;1 however,…
  • Abstract Number: 2799 • 2017 ACR/ARHP Annual Meeting

    Efficacy, Safety and Immunogenicity in Randomized, Double-Blind (DB) and Open-Label Extension (OLE) Studies Comparing FKB327, an Adalimumab Biosimilar, with the Adalimumab Reference Product (Humira®; RP) in Patients (pts) with Active Rheumatoid Arthritis (RA)

    Mark C. Genovese1, Josephine Glover2, Nobuhito Matsunaga3, Diane Chisholm4 and Rieke Alten5, 1Stanford University Medical Center, Palo Alto, CA, 2Coephycient Pharmaceutical Consultancy, Guildford, United Kingdom, 3Fujifilm Kyowa Kirin Biologics, Chiyoda-ku, Tokyo, Japan, 4Fujifilm Kyowa Kirin Biologics, Galashiels, United Kingdom, 5University Medicine Berlin, Berlin, Germany

    Background/Purpose: FKB327 is a proposed biosimilar of the adalimumab RP. A randomized, DB, Phase 3 study (NCT02260791) compared the efficacy, safety, pharmacokinetics (PK) and immunogenicity…
  • Abstract Number: 1471 • 2017 ACR/ARHP Annual Meeting

    Flare Incidence and Predictive Factors in a Population of Patients with Rheumatoid Arthritis Under Optimised Treatment with Adalimumab and Infliximab

    Amara Pieren1, Dora Pascual-Salcedo2, Pilar Aguado3, Gema Bonilla4, Eugenio De Miguel5, Irene Monjo6, Laura Nuño3, Diana Peiteado3, Alejandro Villalba3, Enrique Moral Coro4, C. Tornero7, Patricia Bogas4, Alejandro Balsa3 and Chamaida Plasencia-Rodriguez4, 1Rheumatologyº, Hospital La Paz, Madrid, Spain, 2Immuno-Rheumatology Research group, La Paz University Hospital, Madrid, Spain, 3Rheumatology, La Paz University Hospital, Madrid, Spain, 4Hospital Universitario La Paz, Madrid, Spain, 5Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, 6Internal Medicine, Hospital Universitario La Paz, MADRID, Spain, 7Rheumatology, Rheumatology. La Paz University Hospital, Spain., Madrid, Spain

    Background/Purpose:Anti-TNF has drastically changed the prognostic of the RA,carrying an important healthcare expense.This is why,optimisation seems a successful strategy that should not be linked to…
  • Abstract Number: 2868 • 2017 ACR/ARHP Annual Meeting

    Pharmacodynamic Analysis of Whole Blood Gene Expression over 2 Years in a Phase IIIb Head-to-Head Trial of Abatacept and Adalimumab in Patients with RA

    O Jabado1, MA Maldonado1, Michael Schiff2, Michael Weinblatt3, Roy Fleischmann4, William H. Robinson5, A Greenfield1 and SE Connolly1, 1Bristol-Myers Squibb, Princeton, NJ, 2University of Colorado, Denver, CO, 3Brigham and Women’s Hospital, Boston, MA, 4Metroplex Clinical Research Center Dallas, Dallas, TX, 5Stanford University, Palo Alto, CA

    Background/Purpose: The head-to-head AMPLE study compared the safety and efficacy of abatacept (co-stimulatory modulator) versus adalimumab (TNFα inhibitor) for treatment of RA over 2 years.…
  • Abstract Number: 1521 • 2017 ACR/ARHP Annual Meeting

    Impact of Time Since Diagnosis, Age, and Number of Prior Non-Steroidal Anti-Inflammatory Drugs on 52-Week Clinical Response to Adalimumab in Patients with Ankylosing Spondylitis

    Joachim Sieper1, Atul A. Deodhar2, Maja Hojnik3, Ying Zhang4 and Maxime Dougados5, 1Charité Universitätsmedizin Berlin, Berlin, Germany, 2Oregon Health & Science University, Portland, OR, 3AbbVie, Ljubljana, Slovenia, 4AbbVie Inc., North Chicago, IL, 5René Descartes University and Hôpital Cochin, Paris, France

    Background/Purpose : Ankylosing spondylitis (AS) patients (pts) were found to respond better to TNF inhibitors (TNFi) if treated early in the disease course.1 The actual…
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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 ET on November 14, 2024. 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].

ACR Abstract Embargo Policy

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. 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 a scientific presentation or presentation of additional new information that will be available at the time of the meeting) is under embargo until Saturday, November 11, 2023.

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying financial and other sponsors about this policy. If you have questions about the abstract embargo policy, please contact the public relations department at [email protected].

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