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…Abstract Number: 2528 • 2018 ACR/ARHP Annual Meeting
A Multicenter Study Assessing the Efficacy and Safety of Repository Corticotropin Injection in Patients with Rheumatoid Arthritis: Preliminary Interim Data from the Open-Label Treatment Period
Background/Purpose: Rheumatoid arthritis (RA) is an autoimmune disorder associated with chronic inflammation and commonly treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids. Repository corticotropin injection…Abstract Number: 2529 • 2018 ACR/ARHP Annual Meeting
Liver Function Test Levels with Sarilumab Treatment in Phase 3 Trials: Analysis By Baseline Liver Function Test (LFT) Level
Background/Purpose: Sarilumab showed efficacy in RA and superiority to placebo and adalimumab in Phase 3 trials. This post hoc analysis investigated LFT levels in three…Abstract Number: 2530 • 2018 ACR/ARHP Annual Meeting
Uncovering Clinicians’ Gaps and Attitudes Toward Biosimilars: Impact of a 2-Phase Educational Program
Background/Purpose: Biosimilar agents have changed the clinical landscape in rheumatology, gastroenterology, and dermatology. We sought to measure clinicians’ competence and knowledge of biosimilars and to…Abstract Number: 2531 • 2018 ACR/ARHP Annual Meeting
Assessment of Pain Relief with Baricitinib By Treatment History in Patients with Refractory Rheumatoid Arthritis
Background/Purpose: Baricitinib (BARI) 2 mg and 4 mg once daily demonstrated significant clinical improvements compared to placebo in the phase 3 study of RA patients…
