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

Schouwenburg, Pauline A. van; Bartelds, Geertje M; Hart, Mia van der; Aarden, Lucien A.; Wolbink, Gertjan; Wouters, Diana

doi:10.1016/j.jim.2010.09.005

Cited by 154 publications

(105 citation statements)

References 22 publications

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“…Immunoglobulin therapies have previously been shown to induce expansion of Tregs in vitro and in vivo [72,74]. suggesting that observed immunogenicity for some therapeutics has been underreported due to inadequate assays [86], this retrospective study supports the use of in silico immunogenicity assessment as part of a comprehensive preclinical development strategy [9].…”

Section: Regulatory T Cell Epitopes In Igg Framework Regions: Tregitopessupporting

confidence: 52%

Immunogenicity of Therapeutic Fusion Proteins: Contributory Factors and Clinical Experience

Jawa

Cousens

Groot

2013

Fusion Protein Technologies for Biopharmaceuticals

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Section: Regulatory T Cell Epitopes In Igg Framework Regions: Tregitopessupporting

confidence: 52%

Immunogenicity of Therapeutic Fusion Proteins: Contributory Factors and Clinical Experience

Jawa

Cousens

Groot

2013

Fusion Protein Technologies for Biopharmaceuticals

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“…21 Maxisorp ELISA plates were coated overnight with 2 lg/mL monoclonal anti-TNF-7 (Sanquin) in Phosphate buffered saline (PBS) at room temperature (RT). After five times washing with PBS/0.02% Tween (PT), plates were incubated for 1 h at RT with recombinant TNFa (0.01 lg/mL) (Strathmann Biotech HmbH, Hannover, Germany) diluted in high performance ELISA buffer (HPE, Sanquin Bloodbank, Division Reagents).…”

Section: Methodsmentioning

confidence: 99%

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

Casteele

Buurman

Sturkenboom

et al. 2012

Aliment Pharmacol Ther

185

179

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“…the drug tolerance level will be higher for samples with higher levels of ADA and lower for samples with lower levels of ADA). Whenever possible, drug interference should be minimized using various strategies, including sample acidification pretreatment, more drug‐tolerant assay formats and platforms, use of competing antibodies or monovalent versions of multivalent BP and longer incubation times 39, 59, 62, 63, 64, 65. However, there are caveats to each of these strategies, as they may dissociate incompletely the immune complexes, may denature and reduce the binding activity of some ADA, may reduce detection of ADA against some epitopes or may increase the level of target interference.…”

Section: Ada Immune Response Assaysmentioning

confidence: 99%

Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium

Rup

Pallardy

Sikkema

et al. 2015

Clinical and Experimental Immunology

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SummaryBiopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted immunogenic responses to BPs, in particular those affecting clinical safety or efficacy, remain among the most common negative effects associated with this important class of drugs. To manage and reduce risk of unwanted immunogenicity, diverse communities of clinicians, pharmaceutical industry and academic scientists are involved in: interpretation and management of clinical and biological outcomes of BP immunogenicity, improvement of methods for describing, predicting and mitigating immunogenicity risk and elucidation of underlying causes. Collaboration and alignment of efforts across these communities is made difficult due to lack of agreement on concepts, practices and standardized terms and definitions related to immunogenicity. The Innovative Medicines Initiative (IMI; www.imi-europe.org), ABIRISK consortium [Anti‐Biopharmaceutical (BP) Immunization Prediction and Clinical Relevance to Reduce the Risk; www.abirisk.eu] was formed by leading clinicians, academic scientists and EFPIA (European Federation of Pharmaceutical Industries and Associations) members to elucidate underlying causes, improve methods for immunogenicity prediction and mitigation and establish common definitions around terms and concepts related to immunogenicity. These efforts are expected to facilitate broader collaborations and lead to new guidelines for managing immunogenicity. To support alignment, an overview of concepts behind the set of key terms and definitions adopted to date by ABIRISK is provided herein along with a link to access and download the ABIRISK terms and definitions and provide comments (http://www.abirisk.eu/index_t_and_d.asp).

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

Cited by 154 publications

References 22 publications

Immunogenicity of Therapeutic Fusion Proteins: Contributory Factors and Clinical Experience

Immunogenicity of Therapeutic Fusion Proteins: Contributory Factors and Clinical Experience

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

Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortium

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