Abstracts tagged "Biologics"

Abstract Number: 2460 • 2017 ACR/ARHP Annual Meeting
Patient-Reported Outcomes Following Discontinuation of Methotrexate in Patients with Rheumatoid Arthritis Treated with Subcutaneous Tocilizumab: Results from a Randomized Controlled Trial
Joel Kremer¹, William F C Rigby², Nora Singer³, Christine Birchwood⁴, Darcy Gill⁴, William Reiss⁴, Jennie Best⁴, Jinglan Pei⁴ and Margaret Michalska⁴, ¹Albany Medical College, Albany, NY, ²Geisel School of Medicine at Dartmouth, Lebanon, NH, ³Case Western Reserve University School of Medicine, Cleveland, OH, ⁴Genentech, Inc., South San Francisco, CA
Background/Purpose: Patients with rheumatoid arthritis (RA) often receive methotrexate (MTX) in combination with biologics; however, MTX may be discontinued due to intolerance or to reduce…
Abstract Number: 2878 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety Results of Guselkumab in Patients with Active Psoriatic Arthritis over 56 Weeks from a Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study
Atul A. Deodhar¹, Alice B Gottlieb², Wolf-Henning Boehncke³, Bin Dong⁴, Yuhua Wang⁴, Yanli Zhuang⁴, William Barchuk⁵, Xie L. Xu⁵ and Elizabeth Hsia⁴, ¹Division of Arthritis & Rheumatic Diseases OP09, Oregon Health & Science University, Portland, OR, ²Department of Dermatology, New York Medical College, Valhalla, NY, ³Geneva University Hospital and University of Geneva, Geneva, Switzerland, ⁴Janssen Research & Development, LLC, Spring House, PA, ⁵Janssen Research & Development, LLC, San Diego, CA
Background/Purpose: Evaluate efficacy and safety of guselkumab (GUS) in patients (pts) with active psoriatic arthritis (PsA) over 56 weeks (wks). Methods: Pts w/active PsA (defined…
Abstract Number: 597 • 2017 ACR/ARHP Annual Meeting
Ixekizumab Improves Patient-Reported Outcomes through 52 Weeks in Patients with Active Psoriatic Arthritis and Previous Inadequate Response to Tumor Necrosis Factor-Inhibitors
Arthur Kavanaugh¹, Helena Marzo-Ortega², Ronald Vender³, Julie Birt⁴, David Adams⁴, Olivier Benichou⁴, Chen-Yen Lin⁴ and Peter Nash⁵, ¹Medicine, University of California, San Diego, La Jolla, CA, ²Department of Rheumatology, Chapel Allerton Hospital, Leeds, United Kingdom, ³Dermatrials Research, Inc., Hamilton, ON, Canada, ⁴Eli Lilly and Company, Indianapolis, IN, ⁵University of Queensland, Brisbane, Australia
Background/Purpose: Ixekizumab (IXE) is a high affinity monoclonal antibody that selectively targets interleukin-17A. Up to 24 weeks, IXE was superior to placebo (PBO) in improving…
Abstract Number: 1044 • 2017 ACR/ARHP Annual Meeting
Medical Care Costs Associated with Rheumatoid Arthritis in the US: A Meta-Analysis
Andrew Hresko¹, Tzu-Chieh Lin² and Daniel H. Solomon³, ¹Tufts Medical School, Boston, MA, ²Health Outcomes, Amgen, Thousand Oaks, CA, ³Brigham and Women's Hospital and Harvard Medical School, Boston, MA
Background/Purpose: Rheumatoid arthritis (RA) is a morbid, mortal, and costly condition without a cure. Treatments for RA have expanded over the last two decades…
Abstract Number: 1528 • 2017 ACR/ARHP Annual Meeting
Secukinumab Provides Rapid and Sustained Pain Relief in Ankylosing Spondylitis Patients with Normal or Elevated Baseline CRP Levels and Correlated with Improvement in Fatigue
Atul A. Deodhar¹, Philip G. Conaghan², Tore K Kvien³, Vibeke Strand⁴, Lawrence Rasouliyan⁵, Brian Porter⁶, Steffen Jugl⁷ and Kunal Gandhi⁶, ¹Oregon Health & Science University, Portland, OR, ²University of Leeds, Leeds, United Kingdom, ³Diakonhjemmet Hospital, Oslo, Norway, ⁴Stanford University School of Medicine, Palo Alto, CA, ⁵RTI Health Solutions, Barcelona, Spain, ⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁷Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Secukinumab has demonstrated sustained efficacy in patients (pts) with active AS.1,2 We investigated improvement in pain and fatigue scores from baseline (BL) through Week…
Abstract Number: 2461 • 2017 ACR/ARHP Annual Meeting
Rituximab Is Effective in the Treatment of Rheumatoid Arthritis Irrespective of Body Mass Index; Up to 48 Weeks Results from Phase 3 Study
Dae-Hyun Yoo¹, Won Park², Chang-Hee Suh³, Seung-Cheol Shim⁴, Sang-Joon Lee⁵, Yun Ju Bae⁵, Chan Park⁵ and Noo Ri Han⁵, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ²Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ³Ajou University School of Medicine, Suwon, Korea, Republic of (South), ⁴Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), ⁵CELLTRION, Inc., Incheon, Korea, Republic of (South)
Background/Purpose: High body mass index (BMI) is known to be associated with inadequate clinical response to anti-TNF agents in RA patients.1 However, there are limited…
Abstract Number: 2879 • 2017 ACR/ARHP Annual Meeting
Switching from Adalimumab to Chs-1420: A Randomized, Double-Blind Global Clinical Trial in Patients with Psoriasis and Psoriatic Arthritis
Jennifer Hodge, Hong Tang, Paula O'Connor and Barbara Finck, Coherus BioSciences, Inc., Redwood City, CA
Background/Purpose: CHS-1420 is a proposed biosimilar to adalimumab. A phase 3, randomized, double-blind, multicenter study evaluated the equivalence of CHS-1420 to adalimumab in patients with…
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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