Abstracts tagged "Biologics"

Abstract Number: 2515 • 2018 ACR/ARHP Annual Meeting
Joint Damage Progression According to Disease Activity States in Patients with Rheumatoid Arthritis Treated with CT-P10 and Reference Rituximab: Up to 48 Weeks Results from Phase III Study
Chang-Hee Suh¹, Dae-Hyun Yoo², Won Park³, Seung-Cheol Shim⁴, Sang-Joon Lee⁵, Yun Ju Bae⁵, Sang Eun Han⁵ and Sang Mi Lee⁵, ¹Rheumatology, Ajou University School of Medicine, Suwon, Korea, Republic of (South), ²Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ³Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ⁴Division of Rheumatology, Department of Internal Medicine, Daejeon Rheumatoid & Degenerative Arthritis Center, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), ⁵CELLTRION, Inc., Incheon, Korea, Republic of (South)
Background/Purpose: CT-P10 is a biosimilar of the reference rituximab (RTX) and has been approved by several regulatory agencies including EMA. Pharmacokinetic and therapeutic equivalence from…
Abstract Number: 2658 • 2018 ACR/ARHP Annual Meeting
Real World Medication Use in Incident Systemic Lupus Erythematosus and Lupus Nephritis Patients
Lin Xie¹, Furaha Kariburyo¹, Janvi Sah¹, Jennifer Lofland² and Nan Li³, ¹STATinMED Research Inc., Ann Arbor, MI, ²Janssen Scientific Affairs, LLC, Horsham, PA, ³Janssen Research & Development, LLC, Spring House, PA
Background/Purpose: Systemic lupus erythematosus (SLE) is an autoimmune disease that causes inflammation in connective tissues and can involve multiple organs systems. Lupus nephritis (LN) is…
Abstract Number: 628 • 2018 ACR/ARHP Annual Meeting
Longitudinal Changes in Relative Market Share Proportions of Biologic and Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs for Treatment of Rheumatoid Arthritis: Descriptive Data from the Ontario Best-Practice Research Initiative Database
Elliot Hepworth¹, Mohammad Movahedi², Emmanouil Rampakakis³, Reza Mirza¹, Arthur Lau⁴, Angela Cesta⁵, Janet E. Pope⁶ and Claire Bombardier⁷, ¹Department of Internal Medicine, McMaster University, Hamilton, ON, Canada, ²JSS Medical Research, St-Laurent, QC, Canada, ³JSS Medical Research, Montreal, QC, Canada, ⁴50 Charlton Avenue East, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada, ⁵Ontario Best Practices Research Initiative, University Health Network, Toronto, ON, Canada, ⁶Department of Medicine, University of Western Ontario, London, ON, Canada, ⁷Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada
Background/Purpose: For patients with Rheumatoid Arthritis (RA) who do not achieve adequate clinical response with combined conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs), the next…
Abstract Number: 1829 • 2018 ACR/ARHP Annual Meeting
Perturbations of the Gut Fungal and Bacterial Microbiome with Biologic Therapy in Spondyloarthritis
Julia Manasson¹, Lu Yang², Gary E. Solomon¹, Soumya M. Reddy¹, Parvathy V. Girija¹, Andrea L. Neimann³, Leopoldo N. Segal⁴, Carles Ubeda⁵, Jose C. Clemente⁶ and Jose U. Scher⁷, ¹Department of Medicine, Division of Rheumatology, New York University School of Medicine, New York, NY, ²New York University School of Medicine, New York, NY, ³Department of Dermatology, New York University School of Medicine, New York, NY, ⁴Department of Medicine, Division of Pulmonary and Critical Care, New York University School of Medicine, New York City, NY, ⁵Institute for Research in Public Health (FISABIO), Valencia, Spain, ⁶Department of Genetics and Genomic Sciences, Icahn Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai, New York, NY, ⁷New York University School of Medicine, New York, NY
Background/Purpose: The microbiome serves a number of important functions, including modulation of the immune system and protection from pathogenic microorganisms1. Many autoimmune diseases have been…
Abstract Number: 2530 • 2018 ACR/ARHP Annual Meeting
Uncovering Clinicians’ Gaps and Attitudes Toward Biosimilars: Impact of a 2-Phase Educational Program
Zachary Schwartz¹, Jenny Schulz¹, Angelique Vinther¹, Alyce Kuklinski¹ and Kenneth Saag², ¹Clinical Care Options, Reston, VA, ²University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Biosimilar agents have changed the clinical landscape in rheumatology, gastroenterology, and dermatology. We sought to measure clinicians’ competence and knowledge of biosimilars and to…
Abstract Number: 2671 • 2018 ACR/ARHP Annual Meeting
Development and First-in-Human Characterization of an ICOSL and BAFF Bispecific Inhibitor AMG 570 for SLE Treatment
Laurence E Cheng¹, Hailing Hsu², Martin Kankam³, Nicholas Siebers⁴, Randall Stoltz⁵, Lubna Abuqayyas², Bella Ertik⁶, Barbara Sullivan², Lei Zhou² and Jane R Parnes², ¹Amgen Inc., South San Francisco, CA, ²Amgen Inc., Thousand Oaks, CA, ³Vince and Associates Clinical Research, Inc.,, Overland Park, KS, ⁴Covance, Madison, WI, ⁵Covance, Evansville, IN, ⁶Amgen Inc, Boston, MA
Background/Purpose: Autoimmune diseases, including systemic lupus erythematosus (SLE), are associated with dysregulated T cell and B cell responses. AMG 570 is a bispecific molecule targeting…
Abstract Number: 11L • 2017 ACR/ARHP Annual Meeting
Risk of Second Malignant Neoplasm and Mortality in Rheumatoid Arthritis Patients Treated with Biological Dmards: A Danish Population-Based Cohort Study
Lene Dreyer¹, René Cordtz², Inger Marie J. Hansen³, Lars Erik Kristensen⁴, Merete Lund Hetland⁵ and Lene Mellemkjær⁶, ¹Center for Rheumatology and Spine Diseases, Gentofte University Hospital,Rigshospitalet, Hellerup, Denmark, ²Center for Rheumatology and Spine Diseases, Gentofte University Hospital, Rigshospitalet, Hellerup, Denmark, ³Department of Reumatology, OUH, Svendborg Hospital, Svendborg, Denmark, ⁴The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen F, Denmark, ⁵DANBIO, Glostrup Hospital.On behalf of all Depts of Rheumatology in Denmark.Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark, Glostrup, Denmark, ⁶Danish Cancer Society Research Center, Copenhagen, Denmark, Copenhagen, Egypt

Background/Purpose: The safety of treatment with biological DMARDs (bDMARDs) has been carefully studied for the past 15 years, however, it is still largely unknown whether…
Abstract Number: 605 • 2017 ACR/ARHP Annual Meeting
Ixekizumab Exhibits a Favorable Safety Profile during 24 Weeks of Treatment in Subjects with Active Psoriatic Arthritis: Integrated Safety Analysis of Two Randomized, Placebo Controlled, Phase III Clinical Trials
Philip J Mease¹, Gerd R. Burmester², Susan Moriarty³, Olivier Benichou³, Wen Xu³ and Peter Nash⁴, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany, ³Eli Lilly and Company, Indianapolis, IN, ⁴University of Queensland, Brisbane, Australia
Background/Purpose: Ixekizumab (IXE) is a high affinity monoclonal antibody that selectively targets IL-17A. The objective of this analysis is to report the integrated safety of…
Abstract Number: 1092 • 2017 ACR/ARHP Annual Meeting
The Ottawa Biologics Safety and Screening Tool
Chrisanna Dobrowolski¹, Ines Midzic², Denise Boone², Anne McCarthy³, Doug Smith², John Thomson², Sheryl Izzi⁴ and Susan Humphrey-Murto², ¹Internal Medicine, The Ottawa Hospital - University of Ottawa, Ottawa, ON, Canada, ²Division of Rheumatology, Department of Medicine, The Ottawa Hospital - University of Ottawa, Ottawa, ON, Canada, ³Division of Infectious Diseases, Department of Medicine, The Ottawa Hospital - University of Ottawa, Ottawa, ON, Canada, ⁴Division of Endocrinology, Department of Medicine, The Ottawa Hospital - University of Ottawa, Ottawa, ON, Canada
Background/Purpose : A large proportion of patients with rheumatologic diseases are now being treated with biologic therapies. Estimates of the use of biologics in patients…
Abstract Number: 1529 • 2017 ACR/ARHP Annual Meeting
Secukinumab Demonstrates Consistent Safety over Long-Term Exposure (up to 3 years) in Patients with Active Ankylosing Spondylitis: Pooled Analysis of Three Phase 3 Trials
Atul A. Deodhar¹, Xenofon Baraliakos², Helena Marzo-Ortega³, Joachim Sieper⁴, Mats Andersson⁵, Brian Porter⁶ and Todd Fox⁵, ¹Oregon Health & Science University, Portland, OR, ²Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ³NIHR LBRC, LTHT and LIRMM, UoL, Leeds, United Kingdom, ⁴Charité University Medicine Berlin, Berlin, Germany, ⁵Novartis Pharma AG, Basel, Switzerland, ⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Secukinumab has demonstrated a consistent and reliable safety profile in three Phase 3 studies in ankylosing spondylitis (AS): MEASURE 1 (NCT01358175), MEASURE 2 (NCT01649375),…
Abstract Number: 2465 • 2017 ACR/ARHP Annual Meeting
Association between Methotrexate Use and Effects of Treatment with a Second Biologic Agent in Rheumatoid Arthritis: A Multiple Imputation Approach
Yoshikazu Ogawa¹, Nobunori Takahashi², Naoki Ishiguro² and Toshihisa Kojima², ¹Sakashita Hospital, Nakatsugawa, Japan, ²Orthopaedic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan
Background/Purpose: Methotrexate (MTX) is recommended and widely prescribed as the first-line, evidence-based therapy for rheumatoid arthritis (RA) patients. Previous studies have demonstrated a significant effect…
Abstract Number: 2951 • 2017 ACR/ARHP Annual Meeting
Responsiveness of the Patient Reported Outcomes Measurement Information System to Golimumab Intravenous and Infliximab Treatment in a Real World Clinical Trial in Rheumatoid Arthritis Patients
Jeffrey R. Curtis¹, Douglas Conaway², Joy Schechtman³, Aaron Broadwell⁴, Alan J. Kivitz⁵, Vance Bray⁶, Shelly Kafka⁷, Dennis Parenti⁷, Shawn Black⁷, Stephen Xu⁸, Wayne Langholff⁸ and Clifton O. Bingham III⁹, ¹Rheumatology & Immunology, University of Alabama at Birmingham, Birmingham, AL, ²Rheumatology/Medicine, Carolina Health Specialists, Myrtle Beach, SC, ³Sun Valley Arthritis Center LTD, Peoria, AZ, ⁴Rheumatology Osteoporosis Specialists, Shreveport, LA, ⁵Altoona Arthritis & Osteoporosis Center, Altoona, PA, ⁶Denver Arthritis Clinic, Denver, CO, ⁷Janssen Scientific Affairs, LLC, Horsham, PA, ⁸Janssen Research & Development, LLC, Spring House, PA, ⁹Rheumatology, Johns Hopkins University, Baltimore, MD
Background/Purpose: The Patient (Pt) Reported Outcomes Measurement Information System (PROMIS [P]) questionnaires developed by the NIH have been validated and are a feasible assessment tool…
Abstract Number: 130 • 2017 ACR/ARHP Annual Meeting
Availability of Clinical Measures for Patients with Rheumatoid Arthritis in Integrated Delivery Networks Who Receive a Biologic or Targeted Synthetic Disease-Modifying Antirheumatic Drug: A Real-World Analysis of an Electronic Health Records Database
Benjamin Chastek¹, Chieh-I Chen², Toshio Kimura², Jonathan Fay², Stephanie Korrer³ and Stefano Fiore⁴, ¹Optum, Eden Prairie, MN, ²Regeneron Pharmaceuticals, Inc., Tarrytown, NY, ³Health Economics and Outcomes Research, Optum, Eden Prairie, MN, ⁴Clinical Science, Sanofi Genzyme, Bridgewater, NJ
Background/Purpose: In patients with rheumatoid arthritis (RA), ACR treatment guidelines recommend treating to targets based on quantitative endpoints, with modification of therapy as needed to…
Abstract Number: 606 • 2017 ACR/ARHP Annual Meeting
Secukinumab Demonstrates Consistent Safety over Long-Term Exposure in Patients with Psoriatic Arthritis and Moderate to Severe Plaque Psoriasis: Updated Pooled Safety Analyses
Philip J Mease¹, Iain B. McInnes², Kristian Reich³, Peter Nash⁴, Mats Andersson⁵, Ken Abrams⁶, Luminita Pricop⁶ and Todd Fox⁵, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²University of Glasgow, Glasgow, United Kingdom, ³Dermatologikum Hamburg, Hamburg, Germany, ⁴University of Queensland, Brisbane, Australia, ⁵Novartis Pharma AG, Basel, Switzerland, ⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ
Background/Purpose: Pooled safety data from secukinumab psoriasis (PSO) and psoriatic arthritis (PsA) clinical trial programs after ~1 year of exposure have been reported previously.1, 2…
Abstract Number: 1163 • 2017 ACR/ARHP Annual Meeting
A First-in-Human Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Novel Anti-Interleukin 1 Biologic Agent, Rph-104, in Healthy Subjects
Ahmet Gul¹, Sibel Ulker², Recep Selim Senturk², Ugur Onsel Turk², Cemil Gurgun², Yan Lavrovsky³, Mikhail Samsonov⁴, Sebnem Ozen⁵ and Serdar Altinel⁶, ¹Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey, ²Ege University Drug Development and Pharmacokinetics Research and Application Centre (ARGEFAR), Izmir, Turkey, ³R-Pharm Overseas, Inc.,, San Diego, CA, ⁴Medical Department, R-Pharm JSC, Moscow, Russian Federation, ⁵Clinical Trial Department, TRPHARM İlac A.S., Istanbul, Turkey, ⁶linical Trial Department, TRPHARM İlac A.S., Istanbul, Turkey
Background/Purpose: Interleukin-1 (IL-1) is highly active pro-inflammatory cytokine, which is responsible for clinical and laboratory findings in hereditary and acquired auto-inflammatory disorders. Blocking IL-1 activity…

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