Abstracts tagged "Biologics"

Abstract Number: 2445 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks
Seung-Cheol Shim¹, Ljubinka Bozic Majstorovic², Alfredo Berrocal Kasay³, Elias Chalouhi El-Khouri⁴, Fedra Irazoque-Palazuelos⁵, Francisco Cons Molina⁶, Francisco G. Medina-Rodriguez⁷, Pedro Miranda⁸, Pavel Shesternya⁹, Jose Chavez Corrales¹⁰, Piotr Wiland¹¹, Slawomir Jeka¹², Olena Garmish¹³, Pawel Hrycaj¹⁴, Natalia Fomina¹⁵, Won Park¹⁶, Chang-Hee Suh¹⁷, Sang-Joon Lee¹⁸, Sung Young Lee¹⁹ and Dae-Hyun Yoo²⁰, ¹Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), ²Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, ³ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, ⁴Clinica Internacional, Lima, Peru, ⁵Centro de Invstigacion y Tratamiento Reumatologico S.C, Mexico City, Mexico, ⁶Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁷Rheumatology, LaSalle University, Mexico City, Mexico, ⁸Centro De Estudios Reumatológicos, Santiago, Chile, ⁹Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹⁰Clinica San Borja, Lima, Peru, ¹¹Department and Clinic of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland, ¹²2nd University Hospital, CM UMK, Department of Rheumatology and Connective Tissue Diseases,, Bydgoszcz, Poland, ¹³Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine, Kyiv, Ukraine, ¹⁴Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ¹⁵Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation, ¹⁶Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ¹⁷Ajou University School of Medicine, Suwon, Korea, Republic of (South), ¹⁸CELLTRION, Inc., Incheon, Korea, Republic of (South), ¹⁹Clinical Planning Department, CELLTRION, Inc., Incheon, Korea, Republic of (South), ²⁰Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South)
Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to…
Abstract Number: 2779 • 2017 ACR/ARHP Annual Meeting
The Patient Perspective on Bdmard Dose Reduction: A Mixed Methods Study
L.M. Verhoef¹, E.M.H. Selten¹, J.E. Vriezekolk¹, A.J.L. de Jong², F.H.J. van den Hoogen^1,3, A.A. Den Broeder^1,3 and M.E.J.L. Hulscher⁴, ¹Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, ²Department of Rheumatology, Rijnstate Arnhem, Arnhem, Netherlands, ³Rheumatology, Radboud university medical centre, Nijmegen, Netherlands, ⁴Radboud Institute for Health Sciences, IQ healthcare, Radboud university medical centre, Nijmegen, Netherlands
Background/Purpose: biological DMARDs (bDMARDs) are effective in the treatment of RA, but are also associated with side-effects and high costs. Dose reduction of bDMARDs, after…
Abstract Number: 550 • 2017 ACR/ARHP Annual Meeting
Long-Term Safety of Tocilizumab from Large Clinical Trial and Postmarketing Populations
Shalini Mohan¹, Margaret Michalska², Jeffrey Yourish², Jinglan Pei², Sara Gale¹, Christine Birchwood² and Erhan Berber², ¹Genentech, South San Francisco, CA, ²Genentech, Inc., South San Francisco, CA
Background/Purpose: Tocilizumab (TCZ) is a recombinant humanized monoclonal antibody targeted against the interleukin-6 receptor that was approved to treat rheumatoid arthritis (RA) in the EU…
Abstract Number: 1040 • 2017 ACR/ARHP Annual Meeting
Perceptions of US Community Rheumatologists on Biosimilars
Janna Radtchenko, Yolaine Smith, Jonathan Kish and Bruce Feinberg, Specialty Solutions, Cardinal Health, Dallas, TX
Background/Purpose: Biosimilars contain a highly similar version of the active substance of an already approved biologic or “reference product.”1 Regulatory agencies mandate that safety, efficacy,…
Abstract Number: 1523 • 2017 ACR/ARHP Annual Meeting
Secukinumab Demonstrates Rapid and Sustained Efficacy in Ankylosing Spondylitis Patients with Normal or Elevated Baseline CRP Levels: Pooled Analysis of Two Phase 3 Studies
Jürgen Braun¹, Joachim Sieper², Robert B.M. Landewé³, Xenofon Baraliakos¹, Corinne Miceli-Richard⁴, Ruvie Martin⁵, Brian Porter⁵, Kunal Gandhi⁵ and Désirée van der Heijde⁶, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ²Charité University Medicine Berlin, Berlin, Germany, ³University of Amsterdam and Atrium Medical Center, Amsterdam, Netherlands, ⁴Department of Rheumatology, Hôpital Bicêtre, Paris, France, ⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁶Leiden University Medical Center, Leiden, Netherlands
Background/Purpose: Inhibition of IL-17A with secukinumab is an approved therapy for patients (pts) with AS.1 It has been previously reported that response rates with TNFα…
Abstract Number: 2449 • 2017 ACR/ARHP Annual Meeting
Comparative Effectiveness of Tocilizumab (TCZ) Monotherapy with Tumor Necrosis Factor Inhibitors (TNFi) in Combination with Varying Doses of Methotrexate (MTX) in Patients with Rheumatoid Arthritis
Leslie R Harrold¹, George W. Reed¹, Jennie Best², Steve Zlotnick², Gioia Persuitte³ and Joel Kremer⁴, ¹University of Massachusetts Medical School, Worcester, MA, ²Genentech, Inc., South San Francisco, CA, ³Corrona, LLC, Southborough, MA, ⁴Albany Medical College and The Center for Rheumatology, Albany, NY
Background/Purpose: Clinical studies have shown that the efficacy of TCZ monotherapy (TCZ mono) is superior to that of TNFi monotherapy and comparable to that of…
Abstract Number: 2871 • 2017 ACR/ARHP Annual Meeting
Anti-RA33 (hnRNP-A2/B1) Autoantibodies Are Associated with the Therapeutic Response to Methotrexate and Anti-TNF Treatment in Patients with Rheumatoid Arthritis
Daniela Sieghart¹, Paul Studenic¹, Farideh Alasti², Daniel Aletaha³, Josef S. Smolen¹ and Günter Steiner², ¹Medical University Vienna, Division of Rheumatology, Department of Internal Medicine III, Vienna, Austria, ²Rheumatology, Medical University of Vienna, Vienna, Austria, ³Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria
Background/Purpose: Besides the determination of rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA), anti-RA33 antibodies (which are directed to the nuclear antigen hnRNP-A2/B1) could be…
Abstract Number: 595 • 2017 ACR/ARHP Annual Meeting
Improved Patient-Reported Outcomes in Psoriatic Arthritis Patients Treated with Abatacept: Results from a Phase III Trial
Vibeke Strand¹, E Alemao², T Lehman², A Johnsen², S Banerjee², HA Ahmad² and Philip J Mease³, ¹Stanford University, Palo Alto, CA, ²Bristol-Myers Squibb, Princeton, NJ, ³Swedish Medical Center and University of Washington, Seattle, WA
Background/Purpose: In the Phase III ASTRAEA study (NCT01860976), abatacept (ABA) significantly increased ACR20 responses, alleviating musculoskeletal symptoms in patients (pts) with active psoriatic arthritis (PsA).1…
Abstract Number: 1041 • 2017 ACR/ARHP Annual Meeting
Real-World Utilization of Biosimilars for Management of Rheumatoid Arthritis (RA) in the US
Janna Radtchenko, Yolaine Smith, Jonathan Kish and Bruce Feinberg, Specialty Solutions, Cardinal Health, Dallas, TX
Background/Purpose: A biosimilar product is a biological product highly similar to another FDA-approved biological product, reference product, and has no clinically meaningful differences in safety…
Abstract Number: 1525 • 2017 ACR/ARHP Annual Meeting
Characteristics and Treatment Patterns Among Patients with Psoriatic Arthritis Initiating Subcutaneously Administered Biologics: Descriptive Analyses from a US Claims Database
Kurt R. Oelke¹, Rahul Garg², Peter Hur³, Olivier Chambenoit³, Amar Q. Majjhoo⁴, Stephani Gray⁵, Kate Higgins⁵ and Jacqueline B. Palmer³, ¹Rheumatic Disease Center, Glendale, WI, ²PRO Unlimited, Inc, East Hanover, NJ, ³Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁴Shores Rheumatology, St. Clair Shores, MI, ⁵Truven Health Analytics, Cambridge, MA
Background/Purpose: To better understand the real-world efficacy of biologics for the treatment of psoriatic arthritis (PsA), there is a need to evaluate the persistence and…
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…

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