ACR Meeting Abstracts

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  • Abstract Number: 2055 • 2015 ACR/ARHP Annual Meeting

    A Phase III, Randomized, Double-Blind Clinical Study Comparing SB4, an Etanercept Biosimilar, with Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (52-week Results)

    Jiri Vencovsky1, Anna Sylwestrzak2, Piotr Leszczyñski3, Wieslawa Porawska4, Asta Baranauskaite5, Vira Tseluyko6, Vyacheslav Zhdan7, Barbara Stasiuk8, Roma Milasiene9, Aaron Alejandro Barrera Rodriguez10, Soo Yeon Cheong11, Jeehoon Ghil11 and Paul Emery12, 1Rheumatology, Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, 2NZOZ Medica Pro Familia Sp. z o.o., Warsaw, Poland, 3Rheumatology and Rehabilitation, Poznan University of Medical Sciences, Poznan, Poland, 4Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland, 5Lithuanian University of Health Sciences, Kaunas, Lithuania, 6Internal Medicine and Rheumatology, Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine, 7M.V.Sklifosovskyi Poltava Regional Clinical Hospital, Poltava, Ukraine, 8Medicome Sp. z o.o., Oswiecim, Poland, 9Klaipeda University Hospital, Klaipeda, Lithuania, 10Unidad de Atención Medica e Investigación en Salud (UNAMIS), Yucatán, Mexico, 11Samsung Bioepis Co., Ltd., Incheon, South Korea, 12Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom

    Background/Purpose: SB4 is a biologic agent developed as a biosimilar of the etanercept reference product (ETN). This study was a randomized, double-blind, multicenter study and…
  • Abstract Number: 2056 • 2015 ACR/ARHP Annual Meeting

    A Randomized, Double-Blind, Phase III Study Comparing SB2, an Infliximab Biosimilar, to the Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 54-Week Results

    Jung-Yoon Choe1, Nenad Prodanovic2, Jaroslaw Niebrzydowski3, Ivan Staykov4, Eva Dokoupilova5, Asta Baranauskaite6, Roman Yatsyshyn7, Mevludin Mekic8, Wieslawa Porawska9, Hana Ciferska10, Krystyna Jedrychowicz-Rosiak11, Agnieszka Zielinska12, Jasmine Choi13, Young Hee Rho13 and Josef S. Smolen14, 1Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, South Korea, 2Clinical Center Banja Luka, Banja Luka, Bosnia, 3Medica Pro Familia, Gdynia, Poland, 4MHAT "Dr. Ivan Seliminski", AD, Sliven, Bulgaria, 5MEDICAL PLUS s.r.o, Uherske Hradiste, Czech Republic, 6Lithuanian University of Health Sciences, Kaunas, Lithuania, 7SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk, Ukraine, 8University Clinic Centre Sarajevo, Sarajevo, Bosnia, 9Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland, 10Revmatologicky ustav, Praha 2, Czech Republic, 11MCBK S.C., Grodzisk Mazowiecki, Poland, 12Medica Pro Familia Sp. z o.o. Spolka Komandytowo-Akcyjna, Warszawa, Poland, 13Samsung Bioepis Co., Ltd., Incheon, South Korea, 14Medical University of Vienna, Vienna, Austria

    Background/Purpose: SB2 is developed as a biosimilar of the infliximab reference product (INF). 30-week efficacy and safety results from a randomized phase III study were…
  • Abstract Number: 2057 • 2015 ACR/ARHP Annual Meeting

    Antibodies to Infliximab in Remicade-Treated Rheumatic Patients Show Identical Reactivity Towards Biosimilars

    Begoña Ruiz-Argüello1, Ainara Maguregui1, Ainhoa Ruiz del Agua1, Dora Pascual-Salcedo2, Ana Martínez2, Teresa Jurado3, Chamaida Plasencia4, Alejandro Balsa5, Francisca Llinares-Tello6, José Rosas7, Nerea Torres1, Antonio Martínez1 and Daniel Nagore1, 1R&D, Progenika-Grifols, Derio, Spain, 2Immunology Unit, La Paz University Hospital-Immunology, Madrid, Spain, 3Immunology, La Paz University Hospital-Idipaz, Madrid, Spain, 4Rheumatology Unit, La Paz University Hospital-Rheumatology, Madrid, Spain, 5Rheumatology, La Paz University Hospital-Rheumatology Department, Madrid, Spain, 6Clinical Analysis, Hospital Marina Baixa, Clinical Analysis, Villajoyosa, Spain, 7Rheumatology, Hospital Marina Baixa, Villajoyosa, Spain

    Background/Purpose: Infliximab (IFX) is the most immunogenic of anti-TNFα drugs available to treat patients with rheumatic diseases. The recent approval of the first infliximab biosimilars in…
  • Abstract Number: 2058 • 2015 ACR/ARHP Annual Meeting

    Efficacy and Safety of Rituximab Biosimilar Candidate (CT-P10) and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase I Randomized Controlled Trial over 72 Weeks

    Dae-Hyun Yoo1, Won Park2, Chang-Hee Suh3, Seung-Cheol Shim4, Slawomir Jeka5, Fidencio Cons Molina6, Pawel Hrycaj7, Wolfgang Spieler8, Piotr Wiland9, Jan Brzezicki10, Eun Young Lee11, Francisco G. Medina-Rodriguez12, Pavel Shesternya13, Sebastiao Radominski14, Marina Stanislav15, Volodymyr Kovalenko16, Donghyuk Sheen17, Leysan Myasoutova18, Mie Jin Lim19, Jung-Yoon Choe20, Taek S. Kwon21 and Sang Joon Lee21, 1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 2Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, 3Department of Rheumatology, Ajou University Hospital, Suwon, South Korea, 4Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, 5University Hospital Nr 2 Dr. Jan Biziel, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Clinic of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, 6Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, 7Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, 8Osteologie und Rheumatologie, ZeFOR GmbH Zentrum für Forschung, Zerbst, Germany, 9Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, 10Wojewodzki Szpital Zespolony w Elablagu, Elblag, Poland, 11Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea, 12Rheumatology, LaSalle University, Mexico City, Mexico, 13Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, 14CETI-Centro de estudos em Terapias Inovadoras, Universidade Federal do Parana, Curitiba, Brazil, 15Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia, 16Section of Non-coronarogenic Myocardial Diseases and Clinical Rheumatology, National Scientific Center, Kiev, Ukraine, 17Rheumatology, Eulji University Hospital, Daejeon, South Korea, 18City Reumatology Center, Research Medical Complex Vashe Zdorovie, Kazan, Russia, 19Division of Rheumatology, Departments of Internal Medicine, Inha University Hospital, Incheion, South Korea, 20Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, South Korea, 21CELLTRION, Inc., Incheon, South Korea

    Background/Purpose: CT-P10 is a biosimilar candidate of innovator rituximab (RTX). PK profile and clinical data up to week 24 has been reported at ACR 20131.…
  • Abstract Number: 2059 • 2015 ACR/ARHP Annual Meeting

    Tumor Necrosis Factor Inhibitor Tapering Induced Radiographic Progression Is Driven By Weighted Mean Disease Activity over Time, Not Flaring or Lower TNFi Exposition

    Alfons A. den Broeder1, Chantal A.M. Bouman1, Aatke van der Maas2, Frank H.J. van den Hoogen1, Noortje van Herwaarden1 and R. Landewe3, 1Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, 2Hengstdal 3, Sint Maartenskliniek, Nijmegen, Netherlands, 3Department of Internal Medicine, Division of Rheumatology, University Hospital Maastricht, Maastricht, Netherlands

    Background/Purpose: DRESS, a randomized controlled strategy trial (RCT)1investigating disease activity guided tapering of etanercept and adalimumab compared to usual care in RA patients, indicated that…
  • Abstract Number: 2060 • 2015 ACR/ARHP Annual Meeting

    Microscopic Bowel Inflammation in Spondyloarthritis As a Baseline Predictor of Anti-TNF Response

    Heleen Cypers, Gaëlle Varkas, Filip van Den Bosch and Dirk Elewaut, Rheumatology, Ghent University Hospital, VIB, Ghent, Belgium

    ·      Background/Purpose: Microscopic bowel inflammation without associated gastro-intestinal symptoms is present in up to 50% of spondyloarthritis (SpA) patients. Two types of inflammation are distinguished based…
  • Abstract Number: 2061 • 2015 ACR/ARHP Annual Meeting

    Uncovering Crohn’s Disease in Patients with Spondyloarthropathies Using Videocapsule Endoscopy

    Uri Kopylov1, Craig Watts2, Michael Starr3,4, Serge Dionne5, Jamie Koenekoop5 and Ernest Seidman5, 1Gastroenterolog, Research Institute of the McGill University Health Centre, Montreal, QC, Canada, 2Department of Rheumatology, McGill University and Montreal General Hospital, Sainte-Anne-de-Bellevue, QC, Canada, 3Rheumatology, McGill University, Montreal, QC, Canada, 4Rheumatology, McGill University Health Centre, Montreal, QC, Canada, 5Gastroenterology, Research Institute of the McGill University Health Centre, Montreal, QC, Canada

    Background/Purpose: Inflammatory bowel disease (IBD) is clinically associated with spondylarthropathies (SpA) in 5-15% of cases. Protocol colonoscopic assessment demonstrated asymptomatic inflammation characteristic of Crohn’s disease…
  • Abstract Number: 2062 • 2015 ACR/ARHP Annual Meeting

    How Reliable Is Self-Evaluation of Symptoms of Inflammatory Back Pain By Patients?

    Denis Poddubnyy1, Inge Spiller1, Joachim Sieper1 and Martin Rudwaleit1,2, 1Charité Universitätsmedizin Berlin, Berlin, Germany, 2Klinikum Bielefeld, Bielefeld, Germany

    Background/Purpose: Inflammatory back pain (IBP) is regarded as an important clinical parameter of axial spondyloarthritis (axSpA) and is often used in a diagnostic approach. Usually…
  • Abstract Number: 2063 • 2015 ACR/ARHP Annual Meeting

    The Survival Impact of Statins in Psoriasis and Psoriatic Arthritis: A General Population-Based Cohort Study

    Sian Yik Lim1, Na Lu2 and Hyon K. Choi2, 1Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 2Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA

    Background/Purpose: Given their lipid-lowering and anti-inflammatory properties, statins may have dual cardioprotective and anti-rheumatic benefits in psoriasis or psoriatic arthritis. These effects may confer survival…
  • Abstract Number: 2064 • 2015 ACR/ARHP Annual Meeting

    Increase in IL-31 Serum Level in Recent Onset Spondyloarthritis – Data from the DESIR Cohort

    Nicolas Rosine Jr.1, Adrien Etcheto2, Anna Moltó3, Yassine Taoufik4, Houria Chavez4, Christian Roux5, Karine Briot5, Maxime Dougados6 and Corinne Miceli5, 1Rheumatology Department, Hôpital Kremlin Bicêtre, Paris, France, 2Rheumatology B, Rheumatology B Department, Paris-Descartes University, Cochin Hospital, Paris, France, 3Paris Descartes University, Rheumatology Department, Cochin Hospital, AP-HP. INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité,, Paris, France, 4Biologic Immunology, Hopital Bicetre, Université Paris Sud, AP-HP, Kremlin Bicetre, France, 5Rheumatology B Department, Hôpital Cochin, Paris, France, 6Rheumatology B Department,, Paris-Descartes University, APHP, Cochin Hospital, Paris, France

    Background/Purpose: IL-31 is a newly-described cytokine mainly produced by activated Th2 cells. IL-31 acts through IL31-RA and oncostatin heterodimeric receptors that activate STAT3 and STAT5. So far, IL31 has…
  • Abstract Number: 2065 • 2015 ACR/ARHP Annual Meeting

    Verification of Novel Soluble Biomarkers That Differentiate Patients with Psoriatic Arthritis from Those with Psoriasis without Psoriatic Arthritis

    Vinod Chandran1, Daniela Cretu2,3, Lisa Gao4, Kun Liang4, Antoninus Soosaipillai3 and Eleftherios Diamandis2,3,5, 1Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, 2Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada, 3Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, ON, Canada, 4Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON, Canada, 5Department of Clinical Biochemistry, University Health Network, Toronto, ON, Canada

    Background/Purpose: There is a high prevalence of undiagnosed psoriatic arthritis (PsA) in psoriasis patients. Therefore identifying soluble biomarkers for PsA will help in screening psoriasis…
  • Abstract Number: 2066 • 2015 ACR/ARHP Annual Meeting

    Elevated Innate, Adaptive, and TNF-Superfamily Soluble Inflammatory Mediators Mark Impending Disease Flare, While Regulatory Mediators Distinguish Lack of Impending Disease Flare in African-American SLE Patients with Active Disease

    Melissa E. Munroe1, Evan G. Vista2, Joan T. Merrill3, Joel M. Guthridge1, Virginia C. Roberts1 and Judith A. James4, 1Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, 2Rheumatology and Clinical Immunology, University of Santo Tomas, Taguig City, Philippines, 3Clinical Pharmacology, Oklahoma Medical Research Foundation, Oklahoma City, OK, 4Arthritis and Clinical Immunology, University of Oklahoma Health Sciences Center and Oklahoma Medical Research Foundation, Oklahoma City, OK

    Background/Purpose: SLE is a multifaceted disease characterized by immune dysregulation and varied disease activity. Identifying mechanistic mediators of altered disease activity would help prevent damage…
  • Abstract Number: 2067 • 2015 ACR/ARHP Annual Meeting

    De-Convolution of Whole Blood Transcriptomic Data from a Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial of Abatacept in Systemic Lupus Erythematosus

    S Bandyopadhyay1, SE Connolly1, O Jabado1, S Kelly1, M Maldonado1, R Westhovens2, P Nash3, JT Merrill4 and R Townsend1, 1Bristol-Myers Squibb, Princeton, NJ, 2University Hospitals KU Leuven, Leuven, Belgium, 3University of Queensland, Brisbane, Australia, 4Oklahoma Medical Research Foundation, Oklahoma City, OK

    Background/Purpose: The Phase IIb IM101-042 trial was a randomized, double-blind, placebo-controlled trial of abatacept (ABA) in systemic lupus erythematosus patients (pts) with polyarthritis, discoid lesions…
  • Abstract Number: 2068 • 2015 ACR/ARHP Annual Meeting

    Low Complement Is Associated with SLE Classification Criteria and Organ Damage

    Laura Durcan1, Wei Fu2 and Michelle Petri1, 1Rheumatology, Johns Hopkins University Hospital, Baltimore, MD, 2Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD

    Background/Purpose: Low complements are included in the SLICC classification criteria for systemic lupus erythematosus (SLE) but are not considered in the ACR classification. As a…
  • Abstract Number: 2069 • 2015 ACR/ARHP Annual Meeting

    High Interferon Gene Signature Is Associated with Increased Disease Activity, Reduced Complement C3 and C4, and Increased Oral Corticosteroid Use in Systemic Lupus Erythematosus (SLE)

    K Ranade, L Wang, P Brohawn, W Greth, J Drappa and G Illei, MedImmune, Gaithersburg, MD

    Background/Purpose: Increased expression of genes inducible by type 1 interferons has been observed in a subset of patients with systemic lupus erythematosus (SLE). Oral corticosteroids…
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