Abstract Number: 2513 • 2018 ACR/ARHP Annual Meeting
Change in Disease Activity after Switching Etanercept (originator) to Biosimilar (Benepali) Is Associated with Active Disease at Baseline
Background/Purpose: Biosimilar contains a version of active substance similar of an already approved biological agent in terms of quality, characteristic, biological activity, safety and efficacy.…Abstract Number: 2514 • 2018 ACR/ARHP Annual Meeting
Development of a Subcutaneous Formulation of CT-P13 (Infliximab): Maintenance Subcutaneous Administration May Elicit Lower Immunogenicity Compared to Intravenous Treatment
Background/Purpose: Intravenous (IV) use of CT-P13, an infliximab (INX) biosimilar, has resulted in comparable efficacy, safety and immunogenicity as innovator INX in various indications including…Abstract Number: 2515 • 2018 ACR/ARHP Annual Meeting
Joint Damage Progression According to Disease Activity States in Patients with Rheumatoid Arthritis Treated with CT-P10 and Reference Rituximab: Up to 48 Weeks Results from Phase III Study
Background/Purpose: CT-P10 is a biosimilar of the reference rituximab (RTX) and has been approved by several regulatory agencies including EMA. Pharmacokinetic and therapeutic equivalence from…Abstract Number: 2516 • 2018 ACR/ARHP Annual Meeting
Long-Term Maintenance of Response in Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol
Background/Purpose: The safety and efficacy of certolizumab pegol (CZP) for treating patients (pts) with rheumatoid arthritis (RA) are well-established in a clinical trial setting.1,2 However,…Abstract Number: 2517 • 2018 ACR/ARHP Annual Meeting
The JAK1-Selective Inhibitor Filgotinib Reverses the Disease-Associated Transcriptional Profile Found in the Blood of Patients with Active Rheumatoid Arthritis
Background/Purpose: Filgotinib (FIL), an oral JAK1- selective inhibitor, has shown good safety and efficacy in active rheumatoid arthritis (RA) patients with inadequate response to MTX…Abstract Number: 2518 • 2018 ACR/ARHP Annual Meeting
GS-9876, a Novel, Highly Selective, SYK Inhibitor in Patients with Active Rheumatoid Arthritis: Safety, Tolerability and Efficacy Results of a Phase 2 Study
Background/Purpose: Spleen tyrosine kinase (SYK) mediates immunoreceptor signaling and is essential in activation of cells including B lymphocytes, monocytes, macrophages, dendritic cells, and osteoclasts. SYK…Abstract Number: 2519 • 2018 ACR/ARHP Annual Meeting
Exposure-Efficacy Analysis in DMARD Inadequate Response Rheumatoid Arthritis Patients Treated with GSK3196165 Along with Methotrexate
Background/Purpose: GSK3196165 is an anti-GM-CSF mAb being developed for RA. In a phase IIb dose-finding study (NCT02504671), RA patients with inadequate response to methotrexate were…Abstract Number: 2520 • 2018 ACR/ARHP Annual Meeting
Efficacy of the Reference Biologic Agents in Two Different Types of Randomized Clinical Trials: 1/ the Ones Comparing Their Efficacy Vs. Placebo and 2/ the Ones Comparing Their Efficacy Vs. Biosimilar in Rheumatoid Arthritis: A Systematic Review of Literature and Meta-Analysis
Background/Purpose: Recent randomized clinical trials (RCTs) have shown similar efficacy of biosimilar agents compared to reference agents. Is the efficacy of reference biologic agents different…Abstract Number: 2521 • 2018 ACR/ARHP Annual Meeting
A Randomized, Double-Blind Phase III Study Comparing the Efficacy, Safety and Immunogenicity of PF-06438179/GP1111 (Ixifi™), an Infliximab Biosimilar, and Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Active RA: Results from Week 54 to Week 78
Background/Purpose: PF-06438179/GP1111 (IFX-PF) is an infliximab (IFX) biosimilar for the treatment of immune-mediated inflammatory diseases, including RA. This randomized, double-blind, comparative clinical study evaluated the…Abstract Number: 2522 • 2018 ACR/ARHP Annual Meeting
Biosimilar BI 695501 and Adalimumab Reference Product (RP) Have Similar Efficacy and Safety in Patients (pts) with Moderately-to-Severely Active Rheumatoid Arthritis (RA): Long-Term Results from a Phase IIIb Extension Study (VOLTAIRE®-RAext)
Background/Purpose: Clinical equivalence of BI 695501 to the adalimumab RP has been shown in pts with moderately-to-severely active RA in the Phase III VOLTAIRE®-RA study…Abstract Number: 2523 • 2018 ACR/ARHP Annual Meeting
Rapid Response with Upadacitinib Treatment in Patients with Rheumatoid Arthritis and an Inadequate Response to Csdmards or Bdmards
Background/Purpose: Upadacitinib (UPA), an oral JAK inhibitor selective for JAK1, demonstrated efficacy in patients (pts) with moderate to severe rheumatoid arthritis (RA) with an inadequate…Abstract Number: 2524 • 2018 ACR/ARHP Annual Meeting
Effect of Upadacitinib on Pain and Morning Stiffness in Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic or Biologic Disease-Modifying Anti-Rheumatic Drugs
Background/Purpose: Although treatment with csDMARDs and bDMARDs can lead to remission in patients with RA, many patients still experience pain and morning (AM) stiffness, which…Abstract Number: 2525 • 2018 ACR/ARHP Annual Meeting
Correlation Analysis between Sirukumab Exposure and Selected Safety Events Following Subcutaneous Administration Using Pooled Phase 3 Data in Rheumatoid Arthritis
Background/Purpose: To characterize the exposure-response (ER) relationship between systemic exposure to sirukumab (an anti- interleukin-6 [IL-6] human monoclonal antibody) and the occurrence of selected safety…Abstract Number: 2526 • 2018 ACR/ARHP Annual Meeting
Revealing and Addressing Knowledge Gaps Regarding Biosimilars in Rheumatology Practice with Targeted Continuing Education and Patient Surveys
Background/Purpose: With the recent introduction of biosimilars in the US market, providers lack knowledge of how these agents compare to reference biologics and the implications…Abstract Number: 2527 • 2018 ACR/ARHP Annual Meeting
Long-Term Safety with Sarilumab Plus Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and Sarilumab Monotherapy in Rheumatoid Arthritis (RA): An Integrated Analysis with 9,000 Patient-Years (Pt-Yrs) of Follow-up
Background/Purpose: Sarilumab has shown efficacy in RA both as monotherapy and in combination with csDMARDs in Phase 3 trials. We assessed long-term safety from the…
ACR Meeting Abstracts