Abstracts tagged "infliximab"

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: 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: 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…
Abstract Number: 043 • 2020 Pediatric Rheumatology Symposium
Resolution of Coronary Artery Changes in Patients with Refractory Kawasaki Disease with Prolonged Course of Infliximab: A Case Series
Shelley Shi¹ and Anusha Ramanathan ¹, ¹Kaiser Permanente Los Angeles, Los Angeles, California
Background/Purpose: Treatment for patients with Kawasaki Disease (KD) refractory to standard therapy is controversial. Most experts recommend a second dose of IVIG [1], and for…
Abstract Number: 202 • 2019 ACR/ARP Annual Meeting
Risk Factors Associated with Serious Infections Among Users of Biosimilar and Originator Infliximab Therapies
Cristiano S. Moura ¹, Jeffrey Curtis ², Denis Choquette ³, Gilles Boire ⁴, Vivian P. Bykerk ⁵, Carter Thorne ⁶, Walter P. Maksymowych ⁷, Peter L. Lakatos ⁸, Larry Svenson ⁹, Laura Targownik ¹⁰, Waqqas Afif ⁸ and Sasha Bernatsky¹¹, ¹McGill University Health Centre, Montreal, QC, Canada, ²University of Alabama at Birmingham, Birmingham, AL, ³Institut de Recherche en Rhumatologie de Montréal, University of Montreal, Québec, Canada., Montreal, QC, Canada, ⁴Sherbrooke University, Sherbrooke, QC, Canada, ⁵Hospital for Special Surgery, New York, NY, ⁶Southlake Regional Health Centre, Newmarket, ON, Canada, ⁷University of Alberta/CARE ARTHRITIS, Edmonton, AB, Canada, ⁸McGill University, Montreal, QC, Canada, ⁹University of Alberta, Edmonton, AB, Canada, ¹⁰University of Manitoba, Winnipeg, MB, Canada, ¹¹Research Institute of the McGill University Health Centre, Montreal, QC, Canada
Background/Purpose: Biosimilar use in North America is relatively low, and real-world comparisons of biosimilars and their originator biologics are lacking. We assessed risk factors associated…
Abstract Number: 519 • 2019 ACR/ARP Annual Meeting
Efficacy of Biosimilar Candidate ABP 710 in a Phase 3 Study in Subjects with Moderate to Severe RA: Additional Analysis Focusing on the ACR Individual Components
Mark Genovese¹, Juan Sanchez-Burson ², Éva Balázs ³, Andrea Everding ⁴, MyungShin Oh ⁵, Gary Fanjiang ⁵ and Stanley Cohen ⁶, ¹Stanford University, Stanford, CA, ²Hospital Infanta Luisa, Sevilla, Spain, ³Dr. Bugyi István Hospital, Szentes, Hungary, ⁴HRF Hamburger Rheuma Forschungszentrum, Hamburg, Germany, ⁵Amgen, Thousand Oaks, CA, ⁶Metroplex Clinical Research Center, Dallas, TX
Background/Purpose: ABP 710 is being developed as a biosimilar to infliximab. Both ABP 710 and infliximab reference product (RP) inhibit tumor necrosis factor-alpha. Following demonstration…

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