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  • Abstract Number: 634 • 2016 ACR/ARHP Annual Meeting

    Use of Biosimilars in Clinical Practice: A Swedish National Register-Based Assessment

    Daniela Di Giuseppe1, Thomas Frisell2, Sofia Ernestam3,4, Helena Forsblad D’Elia5, E. Lindqvist6, Ulf Lindström7, Johan Askling8,9 and ARTIS, 1Clinical Epidemiology Unit, Dept. of Medicine, K2, Karolinska institutet, Stockholm, Sweden, 2Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, 3Centre of Rheumatology, Stockholm County Council, Stockholm, Sweden, Stockholm, Sweden, 4Clinical Epidemiology unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden, 5Department of Public Health and Clinical Medicine, Rheumatology, Umeå University, Umeå, Sweden, 6Department of Rheumatology, Lund University, Lund, Sweden, 7Department of Rheumatology and Inflammation Research, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, 8Rheumatology Unit, Karolinska University Hospital, Stockholm, Sweden, 9Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden, Stockholm, Sweden

    Background/Purpose: In March 2015 the first infliximab biosimilars CT-P13 (Remsima™; Inflectra™), entered the Swedish market. The aim of this study was to evaluate the uptake…
  • Abstract Number: 635 • 2016 ACR/ARHP Annual Meeting

    Factors Associated to Lack of Adherence to Subcutaneous Biological Medications in Patients with Rheumatoid Arthritis from Spain. Arco Study

    Jaime Calvo-Alen1, Indalecio Monteagudo2, Georgina Salvador Alarcón3, Enrique Raya Álvarez4, Loreto Carmona5, Luis Cea-Calvo6 and Carlos Marras Fernandez-Cid7, 1Rheumatology, Txagorritxu Hospital, Araba, Vitoria, Vitoria, Spain, 2Rheumatology Unit, HGU Gregorio Marañón, Madrid, Madrid, Spain, 3Rheumatology, HU Mutua de Terrassa, Barcelona, Terrassa, Spain, 4Rheumatology, Hospital Clínico San Cecilio, Granada, Spain, 5Instituto de Salud Musculoesquelética, Madrid, Spain, 6Medical Affairs Department, Merck Sharp & Dohme, Madrid, Spain, 7Rheumatology, Hospital Virgen de la Arrixaca, Murcia, Spain

    Background/Purpose: To investigate the variables associated to lack of adherence to subcutaneous (SC) biological drug in patients with rheumatoid arthritis (RA) after 1 year of…
  • Abstract Number: 636 • 2016 ACR/ARHP Annual Meeting

    Prospective, Intervention, Multicenter Study of Utility of Biologic Drug Monitoring with Respect to the Efficacy and Cost of Adalimumab Tapering in Patients with Rheumatic Diseases (34-week descriptive data)

    Iñigo Gorostiza1, Eduardo Úcar Angulo2, Catalina Gómez Arango2, Clara Eugenia Perez3, Juan Ramon De Dios4, Belen Alvarez4, Ana Ruibal Escribano4,5, Claudia Stoye4, Margarida Vasques4, Joaquin Belzunegui Otano6, Antonio Escobar7, Ziortza Trancho8, Ainhoa Ruiz del Agua9, Lorena Del Rio9, Antonio Martínez9 and Daniel Nagore9, 1Research Department, Hospital Universitario de Basurto, Bilbao, Spain, 2Rheumatology, Rheumatology Department, Basurto University Hospital, Bilbao, Spain, 3Rheumatology, Hospital Universitario de Basurto, Bilbao, Spain, 4Rheumatology, Hospital Universitario de Araba, Vitoria, Spain, 5Rheumatology, Hospital Universitario de Araba, Vittoria, Spain, 6Donostia University Hospital, San Sebastian, Spain, 7Unidad de Investigación, Red de Investigación en Servicios de Salud en enfermedades crónicas (REDISSEC), Hospital Universitario de Basurto, Bilbao, Spain, 8Unidad de Investigación, Hospital Universitario de Basurto, Bilbao, Spain, 9R&D, Progenika-Grifols, Derio, Spain

    Background/Purpose:  Adalimumab (ADL) dose tapering based on clinical assessment is a usual practice especially in patients who have achieved clinical remission. The primary aim of…
  • Abstract Number: 637 • 2016 ACR/ARHP Annual Meeting

    Biologic Initiation Patterns Among Rheumatoid Arthritis Patients in Moderate or High Disease Activity While Using Conventional Disease Modifying Anti-Rheumatic Drugs

    Natalie Boytsov1, George W. Reed2, Leslie R Harrold2,3, Xiang Zhang1, Carol L Gaich1, Cynthia J Larmore1, Ying Shan2, S Rebello4 and Andre B. Araujo1, 1Eli Lilly and Company, Indianapolis, IN, 2Corrona, LLC, Southborough, MA, 3UMass Medical School, Worcester, MA, 4Epidemiology, Corrona, Southborough, MA

      Background/Purpose: The purpose of this study was to describe biologic initiation patterns over a 1-year follow-up period in rheumatoid arthritis (RA) patients with moderate…
  • 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…
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