Abstracts tagged "Biologics"

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…
Abstract Number: 1552 • 2017 ACR/ARHP Annual Meeting
Persistency of Tumor Necrosis Factor Inhibitor Therapy in US Patients with Ankylosing Spondylitis: Data from the Corrona Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry
Philip J Mease¹, Désirée van der Heijde², Chitra Karki³, Mei Liu³, Yujin Park⁴ and Jeffrey D. Greenberg⁵, ¹Swedish Medical Center and University of Washington, Seattle, WA, ²Leiden University Medical Center, Leiden, Netherlands, ³Corrona, LLC, Southborough, MA, ⁴Novartis Pharmaceuticals Corporation, East Hanover, NJ, ⁵New York University School of Medicine, New York, NY
Background/Purpose: There are limited data regarding persistency of TNF inhibitor (TNFi) therapies in patients with ankylosing spondylitis (AS) treated in real-world clinical practice. The objective…
Abstract Number: 2484 • 2017 ACR/ARHP Annual Meeting
When Etanercept Switch Fails – Clinical Considerations
Oliver Hendricks and Kim Hørslev-Petersen, King Christian X's Hospital for Rheumatic Diseases, University of Southern Denmark, Institute of Regional Health Research, Denmark, Graasten, Denmark
Background/Purpose: On January 14th 2016 EMA approved the biosimilar Etanercept (SB4, Benepali) for clinical use. A non-medical switch from originator Etanercept (ETA, Enbrel) to SB4…
Abstract Number: 2963 • 2017 ACR/ARHP Annual Meeting
Sirukumab Improves Synovial Vascularity As Measured By Power Doppler Sonography in Rheumatoid Arthritis Patients from As Early As Week 4 in a Phase 3 Trial
Bidisha Dasgupta¹, Kristen Sweet¹, Dick DeVries², Benjamin Hsu¹, Ian Gourley¹, Matthew Loza¹ and Peter C. Taylor³, ¹Janssen Research & Development, LLC, Spring House, PA, ²Janssen Biologics Europe, Leiden, Netherlands, ³Kennedy Institute of Rheumatology, University of Oxford, Oxford, United Kingdom
Background/Purpose: Ultrasound (US) is an established non-invasive tool for sensitively assessing disease activity at the individual‐joint level in rheumatoid arthritis (RA). Synovial thickness is detectable…
Abstract Number: 137 • 2017 ACR/ARHP Annual Meeting
Rheumatoid Arthritis and the Risk for Interstitial Lung Disease: A Comparison of Risk Associated with Biologic and Conventional Dmards
Fenglong Xie¹, Narender Annapureddy², Lang Chen¹, Jason Leonard Lobo³, Jim C. Oates⁴, Ankoor Shah⁵, Huifeng Yun⁶, Shuo Yang¹ and Jeffrey R. Curtis⁷, ¹Division of Clinical Immunology & Rheumatology, University of Alabama at Birmingham, Birmingham, AL, ²Vanderbilt University Medical Center, Nashville, TN, ³Med-Pulmonary, University of North Carolina, Chapel Hill, NC, ⁴Medicine/Rheumatology & Immunology, Medical University of South Carolina, Charleston, SC, ⁵Medicine, Duke University Medical Center, Durham, NC, ⁶University of Alabama at Birmingham, Birmingham, AL, ⁷Rheumatology & Immunology, University of Alabama at Birmingham, Birmingham, AL
Background/Purpose: Interstitial Lung Disease (ILD) is a rare but often severe consequence of several rheumatologic conditions including rheumatoid arthritis (RA). The comparative risk of incident…
Abstract Number: 612 • 2017 ACR/ARHP Annual Meeting
Safety and Effectiveness of Ustekinumab for the Treatment of Psoriatic Arthritis over a 6 Month Period
Regan Arendse¹, Anna Jaroszynska², Derek Haaland³, Pauline Boulos⁴, Isabelle Fortin⁵, Raheem Kherani⁶, Ariel Masetto⁷, Jonathan Chan⁸, Eliofotisti Psaradellis⁹, Melissa Stutz⁹, Brendan Osborne¹⁰, Francois Nantel¹⁰ and Allen J Lehman¹¹, ¹University of Saskatchewan, Saskatoon, SK, Canada, ²Private practice, Burlington, ON, Canada, ³Rheumatology, Clinical Immunology & Allergy, McMaster University, Barrie, ON, Canada, ⁴Rheumatology, McMaster University, Hamilton, ON, Canada, ⁵Centre de Rhumatologie De l’Est du Quebec, Rimouski, QC, Canada, ⁶University of British Columbia, Richmond, BC, Canada, ⁷Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada, ⁸Rheumatology, University of British Columbia, Vancouver, BC, Canada, ⁹JSS Medical Research, Montreal, QC, Canada, ¹⁰Medical Affairs, Janssen Inc., Toronto, ON, Canada, ¹¹Janssen Inc., Toronto, ON, Canada
Background/Purpose: Ustekinumab (UST) is a fully human immunoglobin monoclonal antibody against interleukin-12 (IL-12) and interleukin-23 (IL-23) that has been proven safe and efficacious for the…

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