Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations

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

Adalimumab elicits a restricted anti-idiotypic antibody response in autoimmune patients resulting in functional neutralisation

(2012) Pauline A van Schouwenburg et al.   ANNALS OF THE RHEUMATIC DISEASES

Comparison of long-term clinical outcome with etanercept treatment and adalimumab treatment of rheumatoid arthritis with respect to immunogenicity

(2012) Charlotte L. Krieckaert et al.   ARTHRITIS AND RHEUMATISM

Epitope characterization of pre-existing and developing antibodies to an aglycosylated monoclonal antibody therapeutic of G1m17,1 allotype

(2012) Suzanna M. Tatarewicz et al.   JOURNAL OF IMMUNOLOGICAL METHODS

In support of the European Union biosimilar framework

(2012) Christian K Schneider et al.   NATURE BIOTECHNOLOGY

A Survey of Applications of Biological Products for Drug Interference of Immunogenicity Assays

(2012) Yow-Ming C. Wang et al.   PHARMACEUTICAL RESEARCH

Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease

(2011) C. Steenholdt et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: A case series and cohort study

(2011) L. A. Korswagen et al.   ARTHRITIS AND RHEUMATISM

Is there a need for immunopharmacologic guidance of anti-tumor necrosis factor therapies?

(2011) Klaus Bendtzen   ARTHRITIS AND RHEUMATISM

Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study

(2011) Marianne Haag-Weber et al.   CLINICAL NEPHROLOGY

Clinical utility of antihuman lambda chain-based enzyme-linked immunosorbent assay (ELISA) versus double antigen ELISA for the detection of anti-infliximab antibodies

(2011) Uri Kopylov et al.   INFLAMMATORY BOWEL DISEASES

Development of Antidrug Antibodies Against Adalimumab and Association With Disease Activity and Treatment Failure During Long-term Follow-up

(2011) Geertje M. Bartelds   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Acute and delayed hypersensitivity reactions to infliximab and adalimumab in a patient with Crohn's disease

(2011) Casper Steenholdt et al.   Journal of Crohns & Colitis

Differential effect of drug interference in immunogenicity assays

(2011) Margreet H. Hart et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity

(2011) Andreas Seidl et al.   PHARMACEUTICAL RESEARCH

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

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

Surprising negative association between IgG1 allotype disparity and anti-adalimumab formation: a cohort study

(2011) Geertje M Bartelds et al.   ARTHRITIS RESEARCH & THERAPY

Correlation of antinuclear antibody and anti-double-stranded DNA antibody with clinical response to infliximab in patients with rheumatoid arthritis: a retrospective clinical study

(2011) Naoichiro Yukawa et al.   ARTHRITIS RESEARCH & THERAPY

Are we ready for therapeutic drug monitoring of biologic therapeutics?

(2011) Charlotte LM Krieckaert et al.   ARTHRITIS RESEARCH & THERAPY

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

The immunogenic part of infliximab is the F(ab')2, but measuring antibodies to the intact infliximab molecule is more clinically useful

(2010) S. Ben-Horin et al.   GUT

A novel method for the detection of antibodies to adalimumab in the presence of drug reveals “hidden” immunogenicity in rheumatoid arthritis patients

(2010) Pauline A. van Schouwenburg et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Cut-off levels and diagnostic accuracy of infliximab trough levels and anti-infliximab antibodies in Crohn's disease

(2010) Casper Steenholdt et al.   SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY

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

(2009) A. Vultaggio et al.   ALLERGY

Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis

(2009) Adedigbo A. Fasanmade et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Influence of Trough Serum Levels and Immunogenicity on Long-term Outcome of Adalimumab Therapy in Crohn's Disease

(2009) Konstantinos Karmiris et al.   GASTROENTEROLOGY

Incidence and clinical significance of immunogenicity to infliximab in Crohnʼs disease

(2009) Andrea Cassinotti et al.   INFLAMMATORY BOWEL DISEASES

Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn’s disease

(2008) R. L. WEST et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis

(2008) T R D J Radstake et al.   ANNALS OF THE RHEUMATIC DISEASES

Immediate Type I Hypersensitivity Response Implicated in Worsening Injection Site Reactions to Adalimumab

(2008) Michael Paltiel et al.   ARCHIVES OF DERMATOLOGY

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

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

Withdrawal of Immunosuppression in Crohn's Disease Treated With Scheduled Infliximab Maintenance: A Randomized Trial

(2008) Gert Van Assche et al.   GASTROENTEROLOGY

Population Pharmacokinetics of Infliximab in Patients With Ankylosing Spondylitis

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

Toward biosimilar monoclonal antibodies

(2008) Christian K Schneider et al.   NATURE BIOTECHNOLOGY

Tumor Necrosis Factor-Alpha Binding Capacity and Anti-Infliximab Antibodies Measured by Fluid-Phase Radioimmunoassays as Predictors of Clinical Efficacy of Infliximab in Crohn's Disease

(2007) Mark A. Ainsworth et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY