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
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
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
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
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
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
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
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
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
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
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
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
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
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: 48 • 2019 ACR/ARP Annual Meeting
Phenotype-based Clustering Along with Analysis of Molecular Profile Might Help to Define Precise CV-risk Profiles in RA Patients
Background/Purpose: 1. To identify and characterize specific immunological, inflammatory and epigenetic determinants involved in the enhanced cardiovascular (CV)-risk present in Rheumatoid Arthritis (RA) patients. 2.…Abstract Number: 202 • 2019 ACR/ARP Annual Meeting
Risk Factors Associated with Serious Infections Among Users of Biosimilar and Originator Infliximab Therapies
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…
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