Abstract Number: 638 • 2016 ACR/ARHP Annual Meeting
A Randomized, Open-Label, Single-Dose, Parallel-Group Trial to Determine the Pharmacokinetics, Safety and Immunogenicity of GP2017, a Proposed Adalimumab Biosimilar, Following a Single Subcutaneous Injection By an Autoinjector or Prefilled Syringe in Healthy Male Subjects
Background/Purpose: The purpose of this study was to describe the pharmacokinetics (PK), safety and immunogenicity of GP2017, a proposed adalimumab biosimilar, administered as a single…Abstract Number: 639 • 2016 ACR/ARHP Annual Meeting
Switching to Biosimilars in Rheumatology: Evidence-Based Practice
Background/Purpose: Biosimilars of originator biologic therapeutics are entering the market, and health care professionals and patients need a clear understanding of these new treatments. The…Abstract Number: 640 • 2016 ACR/ARHP Annual Meeting
Clinical Responses and Synovial Vascularity in Obese Rheumatoid Arthritis Patients Treated with Adalimumab and Methotrexate
Background/Purpose: Obese rheumatoid arthritis (RA) patients (pts) may have higher levels of inflammatory mediators, greater joint swelling and tenderness, and suboptimal response to therapy. We…Abstract Number: 641 • 2016 ACR/ARHP Annual Meeting
Reduction of Concomitant Oral Methotrexate or Corticosteroids in Combination Treatment with Adalimumab Does Not Affect Effectiveness in Patients with Rheumatoid Arthritis
Background/Purpose: In rheumatoid arthritis (RA) patients (pts) receiving corticosteroids (CS) or methotrexate (MTX) with an anti-TNF, such as adalimumab (ADA), the concomitant CS or MTX…Abstract Number: 642 • 2016 ACR/ARHP Annual Meeting
Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis
Background/Purpose: CHS-0214 is in development as a proposed biosimilar of etanercept. This Phase III confirmatory, safety and efficacy study randomized and dosed 644 subjects with…Abstract Number: 643 • 2016 ACR/ARHP Annual Meeting
Exposure-Response Analyses of Efficacy of ABT-122, a Dual-Variable Domain Immunoglobulin (DVD-Ig™) Targeting TNF-α and IL-17A, Compared with Adalimumab in Subjects with Rheumatoid Arthritis and Background MTX
Background/Purpose: ABT-122 is a novel dual-variable domain immunoglobulin (DVD-IgTM), which specifically neutralizes both TNF alpha (TNFα) and interleukin-17A (IL-17). Both cytokines are expressed at increased…Abstract Number: 644 • 2016 ACR/ARHP Annual Meeting
Seroprevalence and Its Impact on Radiographic Damage in Korean Rheumatoid Arthritis Patients Starting Biologics
Background/Purpose: High titers of rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibody (ACCP) are poor prognostic factors for rheumatoid arthritis (RA) patients. Only few studies…Abstract Number: 645 • 2016 ACR/ARHP Annual Meeting
Prospective Observational Real-Life Study (STRATEGE) Shows the Efficacy of Treat-to-Target Strategy and Methotrexate Monotherapy Optimization in Patients with Established Rheumatoid Arthritis
Background/Purpose: Current guidelines consider MTX as initial gold standard treatment for patients (pts) with RA. They also propose various strategies for MTX inadequate responders, among…Abstract Number: 646 • 2016 ACR/ARHP Annual Meeting
Population Pharmacokinetics of ABT-122, an Immunoglobulin Targeting Both TNF-α and IL-17A: Analyses Across Phase 1 Studies in Healthy Volunteers and Phase 2 Studies in Subjects with Rheumatoid or Psoriatic Arthritis
Background/Purpose: ABT-122 is a novel dual-variable domain immunoglobulin (DVD-IgTM), which specifically neutralizes both TNF alpha (TNFα) and interleukin-17A (IL-17). Drugs individually neutralizing TNFα or IL-17…Abstract Number: 647 • 2016 ACR/ARHP Annual Meeting
Genomic and Epigenetic Bioinformatics Demonstrate Dual TNF-α and IL17A Target Engagement By ABT-122, and Suggest Mainly TNF-α–Mediated Relative Target Contribution to Drug Response in MTX-IR Rheumatoid Arthritis Patients
Background/Purpose: ABT-122 is a dual variable domain (DVD-Ig) biologic which inhibits TNF-α and IL17A. In a 12-wk phase 2 study (NCT02141997) in MTX-IR patients (pts)…Abstract Number: 648 • 2016 ACR/ARHP Annual Meeting
ABT-122, an Anti-TNF/Anti-IL-17 Dual Variable Domain Antibody, Alters T Cell Responses in Human Subjects
Background/Purpose: ABT-122 is a dual variable domain antibody which neutralizes both TNF and IL-17 and is in Phase II trials for rheumatoid arthritis (RA) and…Abstract Number: 649 • 2016 ACR/ARHP Annual Meeting
Clinical Evaluation Usefulness of Standardized Protocol Strategies of Dose Reduction in Patients with Rheumatoid Arthritis in Clinical Remission Treated with Biologic Therapies. the Optibio Study
Background/Purpose: The OPTIBIO study is a clinical trial whose primary endpoint is to evaluate the proportion of patients that after one year are maintained in…Abstract Number: 650 • 2016 ACR/ARHP Annual Meeting
ABT-122, a Tnf– and IL-17–Targeted Dual Variable Domain (DVD)–Ig™ in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Results from a Phase 2 Trial
Background/Purpose: Tumor necrosis factor (TNF) and interleukin 17 (IL-17) appear to independently contribute to the pathophysiology of rheumatoid arthritis (RA), synergistically inducing inflammatory mediators leading…Abstract Number: 651 • 2016 ACR/ARHP Annual Meeting
Calprotectin Serum Levels Strongly Predict Disease Flare in RA and Psa Patients with Low Disease Activity Treated with TNF Inhibitors. a One-Year Prospective Cohort Study
Background/Purpose: An increasing number of RA and PsA patients achieve low levels of disease activity under biological therapy. Thus, new biomarkers are needed to stratify…Abstract Number: 652 • 2016 ACR/ARHP Annual Meeting
The Reasons for Discontinuation of Combination Therapy with Methotrexate and Tumor Necrosis Factor Inhibitors Versus Triple Therapy Differ Significantly Because of Higher Adverse Events with Triple Therapy
Background/Purpose: We recently reported that real-world persistence in Veteran’s Affairs (VA) patients was lower in Rheumatoid arthritis (RA) patients receiving triple therapy [methotrexate (MTX), sulfasalazine…
