Abstract Number: 535 • 2019 ACR/ARP Annual Meeting
Exploratory Analysis of a Phase 2b Study Confirms Substantial Pain Improvement with Anti-GM-CSF Monoclonal Antibody Otilimab (GSK3196165) in Patients (Pts) with Active RA
Background/Purpose: Treatment of pain remains a priority for patients (pts) with RA. Otilimab (GSK3196165) is a human mAb that inhibits GM-CSF, a key driver in…Abstract Number: 536 • 2019 ACR/ARP Annual Meeting
PERFUSE: A French Prospective/Retrospective Non-interventional Cohort Study of Infliximab-naïve and Transitioned Patients Receiving Infliximab Biosimilar SB2; An Interim Analysis
Background/Purpose: SB2 is approved in the EU as an infliximab (IFX) biosimilar, having demonstrated bioequivalence and similar efficacy, safety and immunogenicity as the reference. There…Abstract Number: 537 • 2019 ACR/ARP Annual Meeting
Efficacy and Safety Results from a Randomized Double-Blind Study That Compared the Proposed Biosimilar ABP 798 with Rituximab in Subjects with Moderate to Severe RA
Background/Purpose: ABP 798 is being developed as a biosimilar to rituximab, a CD20-directed cytolytic antibody that is approved in the US and EU for treatment…Abstract Number: 538 • 2019 ACR/ARP Annual Meeting
Long-Term Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to CsDMARDs: Results at 60 Weeks
Background/Purpose: Upadacitinib (UPA), an oral, JAK1-selective inhibitor showed efficacy over 12 weeks (wks) in patients (pts) with moderately to severely active rheumatoid arthritis (RA) and…Abstract Number: 539 • 2019 ACR/ARP Annual Meeting
A Randomized Double-Blind Study Comparing Pharmacokinetics (PK) and Pharmacodynamics (PD) of ABP 798 with Rituximab in Subjects with Moderate to Severe RA
Background/Purpose: ABP 798 is being developed as a biosimilar to rituximab, a CD20-directed cytolytic antibody that is approved in the US and EU for treatment…Abstract Number: 540 • 2019 ACR/ARP Annual Meeting
Comparing Real-world Retention Rates in a Matched Cohort of Rheumatoid Arthritis Patients Who Either Remained on the Etanercept Originator or Switched to a Biosimilar
Background/Purpose: In Germany, the first etanercept biosimilar was licensed in 2016. In contrast to other European countries there is no uniform recommendation for the prescription…Abstract Number: 541 • 2019 ACR/ARP Annual Meeting
Multicenter, Evaluator-blinded, Randomized, Non-inferiority Study, to Assess the Efficacy, Safety and Immunogenicity of Etanercept Biosimilar (EtaBS) vs. Reference Etanercept (EtaRef) in Combination with Methotrexate for the Treatment of Patients with Rheumatoid Arthritis
Background/Purpose: Enerceptan® (EtaBS) has been developed as a proposed biosimilar of etanercept. Phase I study demonstrated pharmacokinetic equivalence with EtaRef.Methods: A multicenter, non-inferiority, randomized, assessor -blinded,…Abstract Number: 542 • 2019 ACR/ARP Annual Meeting
‘BENEFIT’ Pan-European Observational Study to Evaluate the Real-world Effectiveness of SB4 Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis or Axial Spondyloarthritis: A Switch Success Story
Background/Purpose: SB4, a biosimilar to the reference ETN, received EU marketing authorisation in January 2016, based on the totality of evidence from pre-clinical and clinical…Abstract Number: 543 • 2019 ACR/ARP Annual Meeting
Cytokine Signaling Pathways Inhibited by Different Biologics in Rheumatoid Arthritis Patients
Background/Purpose: Different types of cells play pathogenic roles in Rheumatoid Arthritis (RA). The immunogenetics of RA suggests a key role of aberrant pathways of T…Abstract Number: 544 • 2019 ACR/ARP Annual Meeting
Tolerance, Survival, and Adherence to Methotrexate Treatment in Patients with Rheumatoid Arthritis
Background/Purpose: Methotrexate (MTX) is the most frequently used medication in patients with Rheumatoid Arthritis (RA). However, several authors have questioned its success due to the…Abstract Number: 545 • 2019 ACR/ARP Annual Meeting
Molecular Analysis of the Mode of Action of Upadacitinib in Rheumatoid Arthritis Patients: Whole Blood RNA Expression Data from the SELECT-NEXT Study
Background/Purpose: Upadacitinib (UPA), an oral JAK inhibitor selective for JAK1, demonstrated efficacy in patients with moderate-to-severe rheumatoid arthritis (RA) with an inadequate response to conventional…Abstract Number: 546 • 2019 ACR/ARP Annual Meeting
Change in Rheumatoid Arthritis (RA)-Related Autoantibody Profile and Risk of Disease Flare After Withdrawal of Therapy in Patients with Early RA Treated with Abatacept and MTX
Background/Purpose: An emerging concept of “immunologic remission” in RA raises questions about the relevance of the RA autoantibody profile in patients (pts) who are otherwise…Abstract Number: 547 • 2019 ACR/ARP Annual Meeting
Inhibition of Structural Joint Damage with Upadacitinib as Monotherapy or in Combination with Methotrexate in Patients with Rheumatoid Arthritis
Background/Purpose: Long‑term prevention of structural joint damage is a key treatment goal in the management of RA1. Upadacitinib (UPA), a JAK1-selective inhibitor, inhibited the progression…Abstract Number: 548 • 2019 ACR/ARP Annual Meeting
Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial
Background/Purpose: Efficacy and safety of a new subcutaneous (SC) formulation (CT-P13 SC) were evaluated up to Week 30. The phase I/III randomized controlled trial in…Abstract Number: 549 • 2019 ACR/ARP Annual Meeting
US Rheumatologists’ Beliefs and Knowledge About Biosimilars – an Ongoing Survey
Background/Purpose: A systematic review of survey literature from 2014-2018 found that clinicians in the US and Europe are cautious about biosimilar use (JMCP; 2019;25:102). We…
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