ACR Meeting Abstracts

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Abstracts tagged "infliximab"

  • Abstract Number: 0817 • ACR Convergence 2021

    Biosimilar Infliximab Therapy in Rheumatoid Arthritis, Axial Spondyloarthritis and Psoriatic Arthritis: A Long-term Follow-up Study on Infliximab-naive Patients and Switched Patients from the Originator to the Biosimilar CT-P13

    Hubert MAROTTE1, Maryse Assing2, Nadir Mammar2, Yves Brault3 and Bruno Fautrel4, 1Rheumatology department - Unisersity Hospital of Saint-Etienne, Saint-Etienne, France, 2Inflammation & Immunology - Pfizer, Paris, France, 3Pfizer, Paris, France, 4Pitié Salpêtrière Hospital, APHP, Sorbonne Université, Paris, France

    Background/Purpose: ReFLECT study has been carried out to investigate real life use of CT-P13, the first monoclonal antibody biosimilar to infliximab (IFX) originator.Methods: ReFLECT is…
  • Abstract Number: 1830 • ACR Convergence 2021

    Discontinuation of Tumor Necrosis Factor Inhibitors in Psoriatic Arthritis and Psoriasis

    Sophia Wolfe1, Elizabeth Cheng2, Kavya Ganuthula1, Meika Fang3, Gail Kerr4, Jessica Walsh5, Elizabeth Chang6, Siba Raychaudhuri7, Kyle Brees2, Robert Dellavalle1, Andreas Reimold8 and Liron Caplan9, 1Rocky Mountain Regional VAMC/University of Colorado School of Medicine, Aurora, CO, 2Rocky Mountain Regional VAMC, Aurora, CO, 3David Geffen School of Medicine at UCLA/West Los Angeles Veterans Affairs Medical Center (VAMC), Los Angeles, CA, 4Washington D.C., Veterans Affairs Medical Center (VAMC)/Georgetown and Howard Universities, Washington, DC, 5Salt Lake City Veteran Affairs Medical Center (VAMC)/University of Utah Hospital, Salt Lake City, UT, 6Phoenix VAMC, Phoenix, AZ, 7Sacramento Veterans Affairs Medical Center (VAMC)/University of California-Davis Health, Davis, CA, 8University of Texas – Southwestern Medical Center/Dallas Veterans Affairs Medical Center (VAMC), Dallas, TX, 9Rocky Mountain Regional Veterans Affairs Medical Center (VAMC)/University of Colorado School of Medicine, Aurora, CO

    Background/Purpose: Psoriatic arthritis (PsA) is a chronic inflammatory disease of the joints and skin that affects 1/1000 people in the US. Tumor necrosis factor-alpha (TNF-α)…
  • Abstract Number: 1946 • ACR Convergence 2021

    Therapeutic Drug Monitoring Compared to Standard Infliximab Therapy in Patients with Immune-mediated Inflammatory Diseases: A Randomized Controlled Trial

    Silje Watterdal Syversen1, Guro Goll1, Kristin Jørgensen2, Marthe Brun1, Øystein Sandanger3, Kristin Hammersbøen2, Joseph Sexton1, Inge Olsen3, Johanna Gehin4, David Warren3, Rolf Anton Klaasen3, Trude Bruun5, Maud Kristine Ljoså6, Anne Haugen7, Rune Njålla8, Brigitte Michelsen9, Camilla Zettel10, Yngvill Bragenes11, Svanaug Skorpe12, Eldri Strand13, Pawel Mielnik14, Cato Mørk15, Tore Kvien1, Jørgen Jahnsen2, Nils Bolstad16 and Espen Haavardsholm1, 1Diakonhjemmet Hospital, Oslo, Norway, 2Akershus University Hospital, Lørenskog, Norway, 3Oslo University Hospital, Oslo, Norway, 4Oslo University Hospital, Lillehammer, Nepal, 5The University Hospital of North Norway, Tromsø, Norway, 6Dept. of Rheumatology, Ålesund Hospital, Ålesund, Norway, 7Østfold Hospital Trust, Moss, Norway, 8Nordland Hospital Trust, Bodø, Bodø, Norway, 9Hospital of Southern Norway Trust, Kristiansand, Norway, 10Betanien Hospital, Skien, Norway, 11Vestre Viken Hospital Trust, Drammen, Norway, 12Haugesund Hospital for Rheumatic Diseases, Haugesund, Norway, 13Lillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway, 14Førde Hospital Trust, Førde, Norway, 15Akershus Dermatology Center, Lørenskog, Norway, 16Oslo University Hospital, Radiumhospitalet, Oslo, Norway

    Background/Purpose: Proactive therapeutic drug monitoring (TDM), a treatment strategy based on scheduled assessments of serum drug levels, has been proposed to optimize efficacy and safety…
  • Abstract Number: 0812 • ACR Convergence 2020

    Real-World Utilization of Infliximab (IFX) and Its Biosimilars in Patients (Pts) with Rheumatoid Arthritis (RA) Since the First Biosimilar Approval in the US

    Simon Helfgott1, Janna Radtchenko2, Nehad Soloman3, Kent Kwas Huston4, Jasvinder Singh5 and Colin Edgerton6, 1BWH- HMS, Boston, MA, 2Trio Health, Louisville, CO, 3Arizona Arthritis & Rheumatology Associates, P.C., Peoria, AZ, 4Kansas City Physician Partners, Kansas City, MO, 5University of Alabama at Birmingham, Birmingham, AL, 6Articularis Healthcare, Summerville, SC

    Background/Purpose: Biologics have revolutionized the treatment of autoimmune diseases, though costs and payer restrictions have limited who are treated and when these agents are used. …
  • Abstract Number: 0819 • ACR Convergence 2020

    The Adherence Patterns Among Patients Using Infliximab Bio-originator and Biosimilar

    Joseph Alanaeme1, Sujith Sarvesh1, Jeffrey R Curtis2 and Huifeng Yun2, 1University of Alabama at Birmingham, BIrmingham, AL, 2Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: Infliximab (INF) biosimilar was approved for multiple indications in U.S. in 2016. Although clinical trials have demonstrated that switching from infliximab bio-originator to its…
  • Abstract Number: 1204 • ACR Convergence 2020

    Use of Multi-Biomarker Disease Activity Scores to Assess Biosimilarity in a Phase 3 Randomized Controlled Trial Comparing Biosimilar Infliximab-qbtx (PF‑06438179/GP1111) with EU-Sourced Reference Infliximab in Patients with Active RA

    Jonathan Kay1, Daniel Alvarez2, Muhammad Iftikharur Rehman3, Min Zhang4 and Noriko Iikuni5, 1University of Massachusetts Medical School, Worcester, MA, 2Pfizer, Collegeville, PA, 3Pfizer, Andover, MA, 4Pfizer, La Jolla, CA, 5Pfizer, New York, NY

    Background/Purpose: The multi-biomarker disease activity (MBDA; Vectra® DA, Myriad Genetics, Inc.) score is calculated from concentrations of 12 serum proteins to assess disease activity (DA)…
  • Abstract Number: 1207 • ACR Convergence 2020

    Impact of Body Mass Index on Clinical Responses of Novel Subcutaneous Infliximab (CT-P13 SC) in Patients with Active Rheumatoid Arthritis: 1-Year Results from a Part 2 of Phase I/III Randomized Controlled Trial

    DaeHyun Yoo1, Rene Westhovens2, Piotr Wiland3, Marek Zawadzki4, Delina Ivanova5, Alfredo Berrocal Kasay6, Elias Chalouhi7, Eva Balázs8, SangJoon Lee9, SungHyun Kim9, NooRi Han9 and YooBin Jung9, 1Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 2University Hospitals Leuven, Belgium, Leuven, Belgium, 3Medical Univeristy, Wroclaw, Poland, 4Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, 5Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, 6ABK Reuma SRL, LIMA, Peru, 7Clinica Internacional Sede Lima, Lima, Peru, 8Dr. Bugyi István Hospital, Szentes, Hungary, 9Celltrion, Inc., Incheon, Republic of Korea

    Background/Purpose: In the analysis of PLANETRA, a Phase III randomized controlled trial (RCT), no significant association was found between body mass index (BMI) and clinical…
  • Abstract Number: 1208 • ACR Convergence 2020

    Utility of Measuring the Immunogenicity to CT-P13 for Subcutaneous Use in Patients with Active Rheumatoid Arthritis: 1-Year Results from a Multicenter, Randomized Controlled Pivotal Trial

    Rene Westhovens1, DaeHyun Yoo2, Piotr Wiland3, Marek Zawadzki4, Delina Ivanova5, Alfredo Berrocal Kasay6, Elias Chalouhi7, Eva Balázs8, SangJoon Lee9, SungHyun Kim9, JeeHye Suh9, ChanKyoung Hwang9 and DaeSeok Choi9, 1University Hospitals Leuven, Belgium, Leuven, Belgium, 2Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 3Medical Univeristy, Wroclaw, Poland, 4Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, 5Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, 6ABK Reuma SRL, LIMA, Peru, 7Clinica Internacional Sede Lima, Lima, Peru, 8Dr. Bugyi István Hospital, Szentes, Hungary, 9Celltrion, Inc., Incheon, Republic of Korea

    Background/Purpose: Novel subcutaneous infliximab (CT-P13 SC) was developed to augment the flexibility in the therapeutic use of infliximab and non-inferiority (NI) of CT-P13 SC versus…
  • Abstract Number: 1210 • ACR Convergence 2020

    Patient-Reported Outcomes Measurement Information System (PROMIS) Assessment of Response to Treatment with Golimumab IV or Infliximab in Rheumatoid Arthritis Patients: Results from a Phase 4 Study

    Clifton Bingham III1, Shelly Kafka2, Shawn Black2, Stephen Xu3, Wayne Langholff4 and Jeffrey R Curtis5, 1Johns Hopkins University, Baltimore, MD, 2Janssen Scientific Affairs, LLC, Horsham, PA, 3Janssen Research & Development, LLC, Spring House, 4Janssen Research & Development, LLC, Spring House, PA, 5Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: AWARE (Comparative & Pragmatic Study of Golimumab [GLM] Intravenous [IV] vs Infliximab [IFX] in RA) is a Phase 4 study designed to provide a…
  • Abstract Number: 1772 • ACR Convergence 2020

    Vaccinations of Infants Born to Mothers on TNF Inhibitors: Safe Administration of Live-vaccines Given Per the National Immunization Program

    Eman Satti1, Nawal Hadwan1 and Samar Al Emadi1, 1Hamad medical corporation, DOHA, Qatar

    Background/Purpose: Biologic Disease-Modifying agents (bDMARDs) including TNF inhibitors are increasingly used during pregnancy over the last few decades for a variety of autoimmune conditions. Nevertheless,…
  • Abstract Number: 0032 • ACR Convergence 2020

    A Prospective, Multicenter, Clinical Performance Evaluation Study for an in-vitro Diagnostics Medical Device (PREDYSTIC® Infliximab RA) for Prediction of Infliximab Responsiveness in the Treatment of Rheumatoid Arthritis

    Miklos Sebeszta1, Katalin Tauberne Jakab1, Tamas Ponyi1, Gyula Poor2, Zsolt Hollo1, Laszlo Szilagyi1, Emese Kiss2 and Gabor Zahuczky3, 1Egis Pharmaceuticals, Budapest, Hungary, 2ORFI, Budapest, Hungary, 3UD Genomed, Debrecen, Hungary

    Background/Purpose: Approximately 30-40% of RA patients fail to respond to first biological therapy. Predicting the patient’s responsiveness to the first biological therapy is still an…
  • Abstract Number: 0236 • ACR Convergence 2020

    Safety and Usability of Infliximab Administration by Auto-injector (AI) and Pre-filled Syringe (PFS) in Patients with Active Rheumatoid Arthritis (RA): Patient-reported Experience from a Multicenter, Randomized Controlled Pivotal Trial

    Rene Westhovens1, DaeHyun Yoo2, Piotr Wiland3, Marek Zawadzki4, Delina Ivanova5, Alfredo Berrocal Kasay6, Elias Chalouhi7, Eva Balázs8, SangJoon Lee9, SungHyun Kim9, JeeHye Suh9, NooRi Han9 and HoJae Lee9, 1University Hospitals Leuven, Belgium, Leuven, Belgium, 2Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea, 3Medical Univeristy, Wroclaw, Poland, 4Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, 5Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, 6ABK Reuma SRL, LIMA, Peru, 7Clinica Internacional Sede Lima, Lima, Peru, 8Dr. Bugyi István Hospital, Szentes, Hungary, 9Celltrion, Inc., Incheon, Republic of Korea

    Background/Purpose: The subcutaneous (SC) formulation of CT-P13 received marketing authorization for RA from the EMA by demonstrating non-inferiority compared to CT-P13 intravenous for efficacy in…
  • Abstract Number: 0555 • ACR Convergence 2020

    Utilization and Adherence Among Infliximab Biosimilar Initiators in a U.S. National Commercial Insurance Database

    Sujith Sarvesh1, Joseph Alanaeme1, Jeffrey R Curtis2 and Huifeng Yun2, 1University of Alabama at Birmingham, BIrmingham, AL, 2Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL

    Background/Purpose: Infliximab Biosimilar, the first biosimilar to infliximab, was approved for multiple indications in the U.S. in 2016. Since the utilization of biosimilar in the…
  • Abstract Number: 0556 • ACR Convergence 2020

    Recent Use, Missed Doses and Discontinuation of Infliximab in New-users: Comparisons of Biosimilar and Originator Exposures

    Cristiano Moura1, Jeffrey R Curtis2, Denis Choquette3, Gilles Boire4, Vivian Bykerk5, Carter Thorne6, Walter Maksymowych7, Peter Lakatos1, Larry Svenson8, Laura Targownik5, Waqqas Afif1 and Sasha Bernatsky9, 1McGill University, Montreal, Canada, 2Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, 3Institut de Rhumatologie de Montréal, Montreal, Canada, 4Universite de Sherbrooke, Sherbrooke, Canada, 5University of Toronto, Toronto, Canada, 6Ontario Rheumatology Association, Aurora, Canada, 7University of Alberta, Edmonton, AB, Canada, 8University of Alberta, Edmonton, Canada, 9The Research Institute of the McGill University Health Centre, Montreal, ON, Canada

    Background/Purpose: Biosimilar infliximab offers a potentially lower‐cost treatment option compared to its bio‐originator. However, uptake of biosimilars in general in North America has been slow.…
  • Abstract Number: 042 • 2020 Pediatric Rheumatology Symposium

    Safety Analysis of Infliximab-dyyb as Compared to Infliximab in Pediatric Rheumatic Conditions

    Mary Culp 1, Dusty Lewis 1, Bethanne Thomas 2, Fatima Barbar-Smiley 3, Kyla Driest 4, Edward Oberle 4, Stacy Ardoin 1 and Kelly Wise1, 1Nationwide Children's Hospital, Columbus, 2Nationwide Children's, Columbus, 3Nationwide Children's Hospital, Columbus, Ohio, 4Division of Rheumatology, Nationwide Children's Hospital, Columbus

    Background/Purpose: Infliximab is an effective treatment for many pediatric rheumatic conditions, but high medication cost creates a barrier to patient access. Biosimilar drugs are proven…
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