Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13)

Systematic comparison of drug-tolerant assays for anti-drug antibodies in a cohort of adalimumab-treated rheumatoid arthritis patients

(2015) Karien Bloem et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

(2014) G. Shankar et al.   AAPS Journal

Clinical Implications of Measuring Drug and Anti-Drug Antibodies by Different Assays When Optimizing Infliximab Treatment Failure in Crohn's Disease: Post Hoc Analysis of a Randomized Controlled Trial

(2014) Casper Steenholdt et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Comparison of two ELISA versions for infliximab serum levels in patients diagnosed with ankylosing spondylitis

(2014) Diana Hernández-Flórez et al.   RHEUMATOLOGY INTERNATIONAL

A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

(2013) Dae Hyun Yoo et al.   ANNALS OF THE RHEUMATIC DISEASES

A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study

(2013) Won Park et al.   ANNALS OF THE RHEUMATIC DISEASES

The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab

(2013) Bella Ungar et al.   GUT

The decline of anti-drug antibody titres after discontinuation of anti-TNFs: implications for predicting re-induction outcome in IBD

(2012) S. Ben-Horin et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays

(2012) N. Vande Casteele et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Biosimilars: what clinicians should know

(2012) M. Weise et al.   BLOOD

Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum

(2012) Shui-Long Wang et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Assay interference caused by antibodies reacting with rat kappa light-chain in human sera

(2011) Søren E. Degn et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis

(2011) D. Pascual-Salcedo et al.   RHEUMATOLOGY

Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases

(2011) Emilie Ducourau et al.   ARTHRITIS RESEARCH & THERAPY

Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension

(2010) N. Ruperto et al.   ANNALS OF THE RHEUMATIC DISEASES

Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development

(2010) Alvydas Mikulskis et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

(2010) Frank R. Brennan et al.   mAbs

Exploring the Binding Sites of Anti-Infliximab Antibodies in Pediatric Patients With Rheumatic Diseases Treated With Infliximab

(2010) Miha Kosmač et al.   PEDIATRIC RESEARCH

Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions

(2009) A. Vultaggio et al.   ALLERGY

Immunogenicity of Anti-TNF-α Agents in Autoimmune Diseases

(2009) Nádia Emi Aikawa et al.   CLINICAL REVIEWS IN ALLERGY & IMMUNOLOGY

Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period

(2008) Jürgen Braun et al.   ARTHRITIS AND RHEUMATISM

Immunogenicity of anti-tumor necrosis factor antibodies—toward improved methods of anti-antibody measurement

(2008) Lucien Aarden et al.   CURRENT OPINION IN IMMUNOLOGY

Population Pharmacokinetics of Infliximab in Patients With Ankylosing Spondylitis

(2008) Zhenhua Xu et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

(2008) Gopi Shankar et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS