Abstract Number: 570 • 2015 ACR/ARHP Annual Meeting
Dose Selection of Namilumab, an Anti-GM-CSF Monoclonal Antibody: An Integrated Pharmacokinetic and Pharmacodynamic Approach for Phase II Studies in Patients with Rheumatoid Arthritis
Background/Purpose: Granulocyte macrophage-colony stimulating factor (GM-CSF) mediates a range of immunological and inflammatory processes, and plays a role in a variety of inflammatory diseases. Namilumab…Abstract Number: 972 • 2015 ACR/ARHP Annual Meeting
A Phase 2b Study Evaluating the Efficacy and Safety of Subcutaneously Administered Tregalizumab in Subjects with Active Rheumatoid Arthritis (RA) Despite Treatment with Methotrexate (MTX)
Background/Purpose: In autoimmune diseases reduced numbers and functional impairment of regulatory T cells (Tregs) have been observed (1). Tregalizumab (BT-061) is a humanized, anti-CD4 mAb,…Abstract Number: 1112 • 2015 ACR/ARHP Annual Meeting
Obinutuzumab Outperforms Rituximab at Inducing B-Cell Cytotoxicity in Vitro through Fc-Mediated Effector Mechanisms in Rheumatoid Arthritis and Systemic Lupus Erythematosus
Background/Purpose: Obinutuzumab (OBZ, a Type II anti-CD20 monoclonal antibody [mAb] with afucosylated Fc portion and enhanced affinity for Fcγ receptor III) is more efficient than…Abstract Number: 1828 • 2015 ACR/ARHP Annual Meeting
Target Modulation of a Type I Interferon Gene Signature and Pharmacokinetics of Anifrolumab in a Phase IIb Study of Patients with Moderate to Severe Systemic Lupus Erythematosus
Background/Purpose: Anifrolumab is a fully human IgG1 monoclonal antibody directed against subunit 1 of the type I interferon receptor (IFNAR1). Anifrolumab blocks the binding of…Abstract Number: 2058 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar Candidate (CT-P10) and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase I Randomized Controlled Trial over 72 Weeks
Background/Purpose: CT-P10 is a biosimilar candidate of innovator rituximab (RTX). PK profile and clinical data up to week 24 has been reported at ACR 20131.…Abstract Number: 2144 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Different Dose Regimens of a Selective IL-23p19 Inhibitor (BI 655066) Compared with Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis with and without Psoriatic Arthritis
Background/Purpose: IL-23 is essential for the differentiation and maintenance of Th17 cells in psoriasis and psoriatic arthritis (PsA). We assessed the efficacy and safety of…Abstract Number: 2749 • 2015 ACR/ARHP Annual Meeting
A Phase 1 Study of FPA008, an Anti-Colony Stimulating Factor 1 Receptor (anti-CSF1R) Antibody in Patients (pts) with Rheumatoid Arthritis (RA): Preliminary Results
Background/Purpose: FPA008 is a humanized IgG4 anti-CSF1R antibody that blocks the binding of CSF1 and IL34 ligands to CSF1R, resulting in inhibition of the activation…Abstract Number: 953 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Human Anti–Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis and Inhibits Radiographic Progression: Efficacy and Safety Data from a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study
Background/Purpose Secukinumab has demonstrated significant and rapid efficacy in the treatment of psoriasis in two phase 3 studies. We present the first randomized, multicenter, double-blind,…Abstract Number: 947 • 2014 ACR/ARHP Annual Meeting
Efficacy and Safety of NNC01140006, an Anti-IL-21 Monoclonal Antibody, in Patients with Active Rheumatoid Arthritis
Background/Purpose A phase 2, randomised, double-blind, placebo-controlled, parallel-group trial was conducted to evaluate the efficacy and safety of NNC0114-0006 in patients with active rheumatoid arthritis…Abstract Number: 954 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Monoclonal Antibody to Interleukin-17A, Provides Significant and Sustained Inhibition of Joint Structural Damage in Active Psoriatic Arthritis Regardless of Prior TNF Inhibitors or Concomitant Methotrexate: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study
Background/Purpose Approximately two-thirds of patients (pts) with psoriatic arthritis (PsA) experience progressive joint damage associated with varying degrees of disability. Here we present the 1-year…Abstract Number: 819 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Monoclonal Antibody to Interleukin-17A, Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: Results of a 52-Week Phase 3 Randomized Placebo-Controlled Trial with Intravenous Loading and Subcutaneous Maintenance Dosing
Background/Purpose A phase 2, proof-of-concept study indicated that secukinumab, an anti–IL-17A monoclonal antibody, suppressed signs and symptoms of active ankylosing spondylitis (AS) by Week (Wk)…Abstract Number: 550 • 2014 ACR/ARHP Annual Meeting
Secukinumab, an Anti–Interleukin-17A Monoclonal Antibody, Improves Physical Function, Quality of Life and Work Productivity in Patients with Active Psoriatic Arthritis: Results from a Phase 3, Randomized, Controlled Trial
Background/Purpose Psoriatic arthritis (PsA) has a significant adverse effect on patients’ health-related quality of life (HRQoL), affecting their physical and emotional functioning and psychological health.…Abstract Number: 538 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Monoclonal Antibody to Interleukin-17A, Significantly Improves Physical Function and Quality of Life in Subjects with Active Ankylosing Spondylitis: Results of a Phase 3 Randomized, Placebo-Controlled Trial with Intravenous Loading and Subcutaneous Maintenance Dosing
Background/Purpose: Ankylosing spondylitis (AS) can have a profound negative effect on an individual's physical functioning, health status and quality of life (QoL), affecting the ability…Abstract Number: 537 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Human Anti–Interleukin-17A Monoclonal Antibody, Significantly Reduces Psoriasis Burden in Patients with Psoriatic Arthritis: Results from a Phase 3 Randomized Controlled Trial
Background/Purpose Reducing the burden of skin manifestations of psoriatic arthritis (PsA) is an important aspect of disease management. Secukinumab, a human anti–IL-17A monoclonal antibody, has…Abstract Number: 536 • 2014 ACR/ARHP Annual Meeting
Secukinumab, a Monoclonal Antibody to Interleukin-17A, Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: Results of a Phase 3, Randomized, Placebo-Controlled Trial with Subcutaneous Loading and Maintenance Dosing
Background/Purpose: Previous data indicate that interleukin (IL)-17, a key pro-inflammatory cytokine, might play a role in the pathogenesis of ankylosing spondylitis (AS). We assessed the…