Abstract Number: 2437 • 2017 ACR/ARHP Annual Meeting
Long-Term Effect of Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, on Radiographic Progression in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Anti-Rheumatic Drug Treatment: Results of a Global Phase 3 Trial
Background/Purpose: In the SIRROUND-D study, sirukumab (SIR), a human monoclonal antibody that selectively binds to the IL-6 cytokine with high affinity, significantly reduced radiographic progression…Abstract Number: 2438 • 2017 ACR/ARHP Annual Meeting
Open Label Transitioning from Originator Etanercept to Biosimilar SB4 Compared to Continuing Treatment with Originator Etanercept in a Historical Cohort in Rheumatic Diseases in Daily Practice
Background/Purpose: Blinded transitioning from originator infliximab (INX) to biosimilar CT-P13 was not inferior to continuing INX treatment.1 Open label mandatory transitioning resulted in a slightly…Abstract Number: 2439 • 2017 ACR/ARHP Annual Meeting
Switching from RA Originator to Biosimilar in Routine Clinical Care: Early Data from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis
Background/Purpose: Biosimilars, biopharmaceuticals assessed by regulatory agencies to have efficacy and safety similar to their reference products, were introduced to the UK market in February…Abstract Number: 2440 • 2017 ACR/ARHP Annual Meeting
Long-Term Efficacy, Safety and Immunogenicity Results from a Randomized, Double-Blind, Phase III Confirmatory Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar, with Reference Adalimumab
Background/Purpose: Based on the evaluation of physicochemical, biological, preclinical, and clinical data, a biosimilar may be approved for use in the same indications for which…Abstract Number: 2441 • 2017 ACR/ARHP Annual Meeting
A Phase III, Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Similarities between LBEC0101 and Etanercept Reference Product in Terms of Efficacy and Safety in Patients with Active Rheumatoid Arthritis Inadequately Responding to Methotrexate
Background/Purpose: LBEC0101 has been developed as a biosimilar to the etanercept reference product (ETN-RP). This study was to evaluate the similarities between LBEC0101 and ETN-RP…Abstract Number: 2442 • 2017 ACR/ARHP Annual Meeting
Biosimilar Candidate BI 695501 and Adalimumab Reference Product Have Similar Efficacy and Safety in Patients with Moderately-to-Severely Active Rheumatoid Arthritis (RA): 1-Year Results from a Phase III Study
Background/Purpose: Clinical equivalence has been shown for BI 695501 and the adalimumab reference product (RP) through similar ACR20 response at Weeks (wks) 12 and 24…Abstract Number: 2443 • 2017 ACR/ARHP Annual Meeting
Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects
Background/Purpose: GP2017 is a proposed adalimumab biosimilar that has been shown to be similar to reference adalimumab at an analytical and preclinical level. The aim…Abstract Number: 2444 • 2017 ACR/ARHP Annual Meeting
Effectiveness and Safety of CT-P13 in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Plaque Psoriasis: Observational Study in Republic of Korea
Background/Purpose: CT-P13 is approved as a biosimilar of innovator infliximab for marketing in 81 countries. After approval, observational study has been conducted in Republic of…Abstract Number: 2445 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks
Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to…Abstract Number: 2446 • 2017 ACR/ARHP Annual Meeting
Minimal and Comparable Radiographic Progression By Disease Activity States in Patients with Rheumatoid Arthritis Who Continued SB5 or Reference Adalimumab and Who Switched to SB5
Background/Purpose : SB5 is a biologic agent developed as a biosimilar of the reference adalimumab (ADL). One year results including radiographic progression from the phase…Abstract Number: 2447 • 2017 ACR/ARHP Annual Meeting
Effectiveness and Tolerability of Benepali in Rheumatoid Arthritis Patients Switched from Enbrel
Background/Purpose: Benepali, the etanercept biosimilar, is licenced in the UK for rheumatoid arthritis (RA) and costs less than Enbrel. This study aimed to evaluate the…Abstract Number: 2448 • 2017 ACR/ARHP Annual Meeting
Increased Cumulative Exposure to Tumor Necrosis Factor Inhibitors Reduces Radiographic Progression in US Veterans with Rheumatoid Arthritis in Real World Clinical Practice
Background/Purpose: While tumor necrosis factor inhibitors (TNFi) have been proven to reduce progression of structural joint damage in rheumatoid arthritis (RA) in randomized clinical…Abstract Number: 2449 • 2017 ACR/ARHP Annual Meeting
Comparative Effectiveness of Tocilizumab (TCZ) Monotherapy with Tumor Necrosis Factor Inhibitors (TNFi) in Combination with Varying Doses of Methotrexate (MTX) in Patients with Rheumatoid Arthritis
Background/Purpose: Clinical studies have shown that the efficacy of TCZ monotherapy (TCZ mono) is superior to that of TNFi monotherapy and comparable to that of…Abstract Number: 2450 • 2017 ACR/ARHP Annual Meeting
Comparative Effectiveness of Abatacept Versus TNFi in Patients with RA Who Are CCP+ in the United States Corrona Registry
Background/Purpose: Anti-cyclic citrullinated peptide positivity (CCP+) is associated with a better response to abatacept than anti-CCP negativity in patients with RA1,2; however, there are no…Abstract Number: 2451 • 2017 ACR/ARHP Annual Meeting
Rapid Onset of Response Observed with Certolizumab Pegol in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate: Efficacy and Safety Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study
Background/Purpose: There are unmet needs for patients (pts) suffering from rheumatoid arthritis (RA) in China, where a limited number of anti-TNFs are available.1, 2 Certolizumab…
ACR Meeting Abstracts