Abstract Number: 593 • 2016 ACR/ARHP Annual Meeting
Adalimumab (HUMIRA) Halts Radiographic Progression and Reduces Disease Activity in Patients with a Poor Initial Response to Methotrexate
Background/Purpose: In patients (pts) with early rheumatoid arthritis (RA), conventional synthetic DMARDs (csDMARDs), preferably methotrexate (MTX), are recommended as first line therapy.1,2 For pts who…Abstract Number: 594 • 2016 ACR/ARHP Annual Meeting
Maintenance of Improvements in Patients’ Physical Function, Workplace and Household Productivity, and Reduction in Caregiver Burden with 2 Years of Certolizumab Pegol Treatment in DMARD-Naive, Early RA Patients with Severe Progressive Disease
Background/Purpose: Rheumatoid arthritis (RA) is associated with loss of physical function, work disability, and decreased quality of life. Early treatment with certolizumab pegol (CZP) in…Abstract Number: 595 • 2016 ACR/ARHP Annual Meeting
Cinical Responses and Improvements in Patient-Reported Outcomes Are Associated with Increased Productivity in the Workplace and at Home in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol
Background/Purpose: Rheumatoid arthritis (RA) is associated with work disability, loss of productivity and reduced quality of life. In established and early RA, compared with MTX…Abstract Number: 596 • 2016 ACR/ARHP Annual Meeting
Association Between Plasma Certolizumab Pegol Concentration and Improvement in Disease Activity in Rheumatoid Arthritis and Crohn’s Disease
Background/Purpose: Anti-TNFs neutralize the TNF-mediated component of inflammatory diseases such as rheumatoid arthritis (RA) and Crohn’s disease (CD) to reduce disease activity. In this study,…Abstract Number: 597 • 2016 ACR/ARHP Annual Meeting
Comparative Effectiveness of Different Anti-TNF Drugs As First Biological DMARD in RA: Results from the Nationwide Swedish Register 2010-2015
Background/Purpose: Although evidence from randomized trials suggest similar efficacy and safety on a group level for the different anti-TNF drugs available for the treatment of…Abstract Number: 598 • 2016 ACR/ARHP Annual Meeting
An Assessment of the Correlation Between Gender and Anticipated Drug Retention to TNF Inhibitors: A Meta-Regression Analysis
Background/Purpose: It is generally believed that a wide variety of patient-specific factors, and in particular gender, are likely to influence the response and tolerability of…Abstract Number: 599 • 2016 ACR/ARHP Annual Meeting
Real World United States-Based Clinical Experience with Prior Biologic Use Among First Time Golimumab Intravenous and Infliximab Treated Rheumatoid Arthritis Patients
Background/Purpose: AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis) is a Phase 4 comparator study designed to provide a real-world…Abstract Number: 600 • 2016 ACR/ARHP Annual Meeting
Disease Activity Trends after Dose Escalation of Infliximab (Remicade) – Results from United States Consortium of Rheumatology Researchers of North America Registry
Background/Purpose: Dose escalation is a common strategy for patients (pts) on infliximab (IFX). This study examined the trend in disease activity across dose escalations to…Abstract Number: 601 • 2016 ACR/ARHP Annual Meeting
Differing Contribution of Methotrexate Polyglutamation to Infliximab and Adalimumab Exposure As Compared to Etanercept
Background/Purpose: Methotrexate (MTX) is known to improve exposure and clinical outcome to anti-tumor necrosis factor (TNF) therapy. While the precise mechanism of action for the…Abstract Number: 602 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of Switching Between Certolizumab Pegol and Adalimumab after Primary Anti-TNF Treatment Failure: 2-Year Results from a Randomized, Investigator-Blind, Superiority Head-to-Head Study
Background/Purpose: EULAR, ACR and treat-to-target guidelines recommend switching treatment in inadequate responders (IRs) to alternative therapy by Week (Wk) 12.1-3 Although any biological (b)DMARD can…Abstract Number: 603 • 2016 ACR/ARHP Annual Meeting
Additional Efficacy Results of SB4 (Etanercept Biosimilar) up to Week 100: Comparison Between Continuing SB4 and Switching from Reference Etanercept (Enbrel®) to SB4
Background/Purpose: SB4 is approved by the European Medicines Agency as a biosimilar of the reference etanercept (ETN). Long term safety and efficacy of SB4 up…Abstract Number: 604 • 2016 ACR/ARHP Annual Meeting
Sustained Efficacy and Comparable Safety and Immunogenicity after Transition to SB5 (an Adalimumab Biosimilar) Vs. Continuation of SB5 or Reference Adalimumab (Humira®) in Patients with Rheumatoid Arthritis: Results of Phase III Study
Background/Purpose: SB5 has been developed as a biosimilar of the reference adalimumab (ADL). The 24-week results of the phase III study have been reported.1 Efficacy,…Abstract Number: 605 • 2016 ACR/ARHP Annual Meeting
Assessment of Comparative Immunogenicity in Biosimilar Development: Immunogenicity and Pharmacokinetics Following a Single Dose of M923, a Proposed Biosimilar for Reference Adalimumab (HUMIRA®), Compared with US- and EU-Sourced Reference Adalimumab in Healthy Subjects
Background/Purpose: 324 healthy volunteers were randomized 1:1:1 to receive a single 40 mg dose of M923, US-sourced reference adalimumab, or EU-sourced reference adalimumab by subcutaneous…Abstract Number: 606 • 2016 ACR/ARHP Annual Meeting
A Randomized, Double Blind, Single Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of ONS-3010 (Adalimumab, Oncobiologics, Inc.) Compared to Two Reference Products of Humira® (AbbVie) in Healthy Adult Subjects
ONS-3010 is being developed as a biosimilar candidate of Humira® (Adalimumab), a full-length recombinant human IgG1 monoclonal antibody specific for TNFα. This study evaluated the b,…Abstract Number: 607 • 2016 ACR/ARHP Annual Meeting
The Clinical Response to Biologic and Non-Biologic Disease Modifying Antirheumatic Drugs (DMARDs) According to Gender in a French-Canadian Population with Rheumatoid Arthritis (RA)
Background/Purpose: Several studies have reported that women with RA had higher level of pain, disease activity and functional impairment compared to men. In addition, women…
