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  • Abstract Number: 1617 • 2016 ACR/ARHP Annual Meeting

    Treatment with Sirukumab, an Anti-IL6 Cytokine Monoclonal Antibody, Improves Fatigue and Health-Related Physical and Emotional Well Being in Patients with Active Rheumatoid Arthritis Refractory to Conventional or Biologic Therapy: Results of 2 Global, Placebo-Controlled, Phase 3 Trials

    Clifton Bingham III1, Yoshiya Tanaka2, George Karpouzas3, Tsutomu Takeuchi4, Daniel Aletaha5, Carter Thorne6, Shihong Sheng7, Weichun Xu7, Ravi Rao8, Kaiyin Fei7, Benjamin Hsu7, Prasheen Agarwal7, Sharon Popik7, Regina Kurrasch9, Steve Peterson7, Rita Ganguly9, Chenglong Han7 and Kelly McQuarrie7, 1Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 2University of Occupational and Environmental Health, Kitakyushu, Japan, 3Division of Rheumatology, Harbor-UCLA Medical Center, Torrance, CA, 4Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan, 5Division of Rheumatology, Medical University of Vienna, Vienna, Austria, 6University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada, 7Janssen Research & Development, LLC, Spring House, PA, 8GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom, 9GlaxoSmithKline, Collegeville, PA

    Background/Purpose: Patients (pts) with rheumatoid arthritis (RA) often experience both substantial fatigue and a decline in their health-related physical and emotional well-being. Sirukumab is a…
  • Abstract Number: 1618 • 2016 ACR/ARHP Annual Meeting

    Leflunomide, Sulfasalazine and Hydroxychloroquine for Rheumatoid Arthritis: Efficacious but Poorly Tolerated

    Kyle A. Register1, Amy C. Cannella2, Ted R. Mikuls3 and James R. O'Dell4, 1Division of Rheumatology and Immunology, University of Nebraska Medical Center, Omaha, NE, 2Section of Rheumatology, University of Nebraska Medical Center, Omaha, NE, 3Internal Medicine, Division of Rheumatology, University of Nebraska Medical Center, Omaha, NE, 4Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE

    Background/Purpose: The combination of methotrexate (MTX), sulfasalazine (SSZ) and hydroxychloroquine (HCQ) (triple therapy) is a highly effective and well-tolerated treatment in rheumatoid arthritis (RA). While…
  • Abstract Number: 1619 • 2016 ACR/ARHP Annual Meeting

    EARTH EXPLORER 2, a Phase IIb Exploratory Study Evaluating Efficacy and Safety of Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor-Alpha Monoclonal Antibody, and the Tumor Necrosis Factor Antagonist Golimumab in Rheumatoid Arthritis

    Michael Weinblatt1, IB McInnes2, JM Kremer3, P Miranda4, J Vencovský5, A Godwood6, M Albulescu6, D Close^6 and GR Burmester^7, 1Brigham and Women’s Hospital, Boston, MA, 2University of Glasgow, Glasgow, United Kingdom, 3The Albany Medical College, Albany, NY, 4Centro De Estudios Reumatológicos, Santiago, Chile, 5Charles University, Prague, Czech Republic, 6MedImmune, Cambridge, United Kingdom, 7Charité – University Medicine Berlin, Berlin, Germany

    Background/Purpose: Mavrilimumab, a fully human monoclonal antibody targeting the granulocyte-macrophage colony-stimulating factor receptor-α, has demonstrated efficacy and safety in disease-modifying antirheumatic drug (DMARD)-inadequate responder (IR)…
  • Abstract Number: 1620 • 2016 ACR/ARHP Annual Meeting

    Pharmacokinetics, Pharmacodynamics, and Immunogenicity of MEDI4920, a Novel, Engineered CD40 Ligand Antagonist, in Healthy Volunteers

    Jing Li1, Michele Gunsior2, Neang Ly1, Alex Godwood3, David Howe3, Marius Albulescu3, Lisa H Butler3, Krista Arbaugh2 and Raffaella Faggioni1, 1MedImmune, Mountain View, CA, 2MedImmune, Gaithersburg, MD, 3MedImmune, Cambridge, United Kingdom

    Background/Purpose:  Fifty-six healthy adult male subjects were randomized in the study at a single site and administered either placebo or MEDI4920 (3, 10, 30, 100,…
  • Abstract Number: 1621 • 2016 ACR/ARHP Annual Meeting

    A Phase I, Randomized, Double Blind, Placebo-Controlled, Dose Escalating Study of the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Hmpl‑523 in Australian Male Healthy Subjects

    Jason Lickliter1, Yan Wu2, Ye Hua2, Irena Yuan2, Guangxiu Dai2, Xiong Li2, Jian Wang2, Yang Sai2, Zhongcui Sun2, Angela Pan2, Jing Li2 and Weiguo Su2, 1Nucleus Network, Melbourne, Australia, 2Hutchison MediPharma Limited, Shanghai, China

    Background/Purpose:   Spleen Tyrosine Kinase (SYK) plays a pivotal role in the regulation of downstream signals in immune receptors, including B cell receptors (BCRs), which…
  • Abstract Number: 1622 • 2016 ACR/ARHP Annual Meeting

    Safety and Efficacy of Iguratimod in Patients with Active Rheumatoid Arthritis: A Multicenter, Single-Arm, Open-Label, Real World Study

    Rong Mu, Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China

    Background/Purpose:  To evaluate the safety and efficacy of iguratimod, a novel DMARD, in active rheumatoid arthritis patients. Methods:  Patients with active rheumatoid arthritis received iguratimod…
  • Abstract Number: 1623 • 2016 ACR/ARHP Annual Meeting

    Early Effects of Tofacitinib on Bone Homeostasis in Patients with Rheumatoid Arthritis

    Masayasu Kitano1, Sachie Kitano1, Tetsuya Furukawa2, Yuichi Yokoyama3, Aki Nishioka1, Masahiro Sekiguchi1, Naoto Azuma1, Kiyoshi Matsui1 and Hajime Sano1, 1Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan, 2Division ofRheumatology Department of internal medicine, Hyogo College of Medicine, Nishinomiya, Japan, 3Division of Rheumatology, Department of internal medicine, Hyogo College of Medicine, Nishinomiya, Japan

    Background/Purpose: The selective Janus kinase (JAK) inhibitor tofacitinib inhibits progression of structural damage in rheumatoid arthritis (RA). These results suggest the possibility that tofacitinib improves…
  • Abstract Number: 1624 • 2016 ACR/ARHP Annual Meeting

    Safety of Surgery in Patients Treated with Tocilizumab for Rheumatoid Arthritis : Data from a French Registry

    Marie Locci1, Bernard Combe2, Cédric Lukas3, Maxime Dougados4, Rene-Marc Flipo5, Christian Marcelli6, Stephanie Rist Bouillon7, Jean Sibilia8 and Jacques Morel9, 1rheumatology, CHU Lapeyronie, MONTPELLIER, France, 2Département Rhumatologie, Hôpital Lapeyronie, Montpellier, France, 3Rheumatology, CHU Lapeyronie and EA2415, Montpellier University, University of Montpellier, France, 4Rheumatology, Paris Descartes University, Paris, France, 5Rheumatology, University Hospital, Lille, France, 6Rheumatology dept, University Hospital Centre of Caen, Caen, France, 7Rhumatologie, Hopital La Source, La Source, France, 8Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, 9Rheumatology, Department of Rheumatology, Montpellier University Hospital, Montpellier, France

    Background/Purpose: Rheumatoid Arthritis (RA) patients have a higher risk of post-operative complications compared with the general population, especially considering the risk of infection. It remains…
  • Abstract Number: 1625 • 2016 ACR/ARHP Annual Meeting

    Analysis of a Phase 3 Study Evaluating the Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Across Subgroups in Patients with Active Rheumatoid Arthritis Despite Treatment with Disease-Modifying Anti-Rheumatic Drugs

    Carter Thorne1, George Karpouzas2, Tsutomu Takeuchi3, Shihong Sheng4, Weichun Xu4, Ravi Rao5, Kaiyin Fei4 and Benjamin Hsu4, 1University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada, 2Division of Rheumatology, Harbor-UCLA Medical Center, Torrance, CA, 3Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan, 4Janssen Research & Development, LLC, Spring House, PA, 5GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom

    Background/Purpose: Sirukumab is a human monoclonal antibody that selectively binds to the IL-6 cytokine with high affinity, and is under development for rheumatoid arthritis (RA)…
  • Abstract Number: 1626 • 2016 ACR/ARHP Annual Meeting

    In Real Life Rheumatoid Arthritis Patients, Leflunomide Has Limited Impact As a Second Line DMARD after Methotrexate

    Gundula Weigt, Anne Erler and Martin Aringer, Medicine III, University Medical Center and Faculty of Medicine at the TU Dresden, Dresden, Germany

    Background/Purpose:  In patients with rheumatoid arthritis (RA), in whom methotrexate (MTX) is not inducing remission or at least low disease activity, or is not tolerated,…
  • Abstract Number: 1627 • 2016 ACR/ARHP Annual Meeting

    Network Meta-Analysis to Assess the Relative Efficacy of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, in Combination Therapy for Patients with Active Rheumatoid Arthritis Despite Conventional Dmards

    Steve Peterson1, Maud Pacou2, Drifa Belhadi2, Suzy Van Sanden1, Thomas Webb1, Rita Ganguly3, Regina Kurrasch3, Ravi Rao3, Benjamin Hsu1, Kaiyin Fei1, Danuta Kielar1 and Rafael Alfonso3, 1Janssen Research & Development, LLC, Spring House, PA, 2Amaris, Paris, France, 3GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom

    Background/Purpose: Sirukumab is a human anti-interleukin-6 cytokine monoclonal antibody evaluated for the treatment of moderate to severe active rheumatoid arthritis (RA) and other diseases.  Our…
  • Abstract Number: 1628 • 2016 ACR/ARHP Annual Meeting

    Distinct Baseline Serum Molecular Profile and Pharmacodynamic Effects of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, in Asian-Pacific Patients with Active Rheumatoid Arthritis Despite DMARD or Anti-Tnfα Therapy Across Two Global Phase 3 Trials

    Bidisha Dasgupta1, Alice Walsh1, Kristen Sweet1, Nancy Peffer1, Carol Franks1, Keying Ma1, Martin Sims2, Kim Campbell1 and Matthew Loza1, 1Janssen Research & Development, LLC, Spring House, PA, 2GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom

    Background/Purpose:  Baseline differences in rheumatoid arthritis (RA) disease characteristics and molecular profile across populations may be a reflection of genetic variations and environmental factors such…
  • Abstract Number: 1629 • 2016 ACR/ARHP Annual Meeting

    Pharmacokinetics of ABT-494 with the Once-Daily Extended-Release Tablet Formulation Being Utilized in the Ongoing Rheumatoid Arthritis Phase 3 Trials

    Mohamed-Eslam Mohamed1, Jiewei Zeng2, In-Ho Song3 and Ahmed A. Othman3, 1Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, 2AbbVie, North Chicago, IL, 3AbbVie Inc., North Chicago, IL

    Background/Purpose: ABT-494 is a selective Janus Kinase 1 inhibitor. In two Phase 2b studies in subjects with rheumatoid arthritis, 6 mg and 12 mg twice-daily…
  • Abstract Number: 1630 • 2016 ACR/ARHP Annual Meeting

    Consistent Pharmacodynamic Effects of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, on Serum Analytes Across Four Phase 3 Clinical Trials in Rheumatoid Arthritis

    Matthew Loza1, Kristen Sweet1, Nancy Peffer1, Carol Franks1, Keying Ma1, Kim Campbell1, Martin Sims2 and Bidisha Dasgupta1, 1Janssen Research & Development, LLC, Spring House, PA, 2GSK Medicines Research Centre, Stevenage, Hertfordshire, United Kingdom

    Background/Purpose: The efficacy of sirukumab, an anti-IL-6 cytokine antibody, was evaluated in multiple phase 3 studies in patients with rheumatoid arthritis (RA)  (SIRROUND -M, -D,…
  • Abstract Number: 1631 • 2016 ACR/ARHP Annual Meeting

    Sarilumab Dose Reduction in an Open-Label Extension Study in RA Patients

    Mark C. Genovese1, Jon Fay2, Janie Parrino2, Doris Beyer3, Melitza Iglesias-Rodriguez4, Neil Graham2, Alex Boddy3, J-Abraham Simon5, Renata Martincova6 and Gerd R. Burmester7, 1Stanford University Medical Center, Palo Alto, CA, 2Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 3Sanofi Genzyme, Bridgewater, NJ, 4Sanofi Genzyme, Cambridge, MA, 5Köhler & Milstein Research, Yucatan, Mexico, 6Sanofi Genzyme, Prague, Czech Republic, 7Charité – University Medicine Berlin, Berlin, Germany

     Background/Purpose: Sarilumab is a human mAb blocking the IL-6Rα. In the phase 3 MOBILITY (NCT01061736) and TARGET (NCT01709578) studies, sarilumab (150 or 200 mg subcutaneously…
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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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