Evidence map›Paper›PMID 25959571›Full record

ReviewClinical and experimental immunology2015

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

B Rup, M Pallardy, D Sikkema, T Albert, M Allez, P Broet, C Carini, P Creeke, J Davidson, N De Vries and 25 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Clinical and experimental immunology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  7. Article
  8. Review
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  14. Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Review
  15. Article
  16. Article
  17. Immunogenicity of biologic agents in rheumatology.Nature reviews. Rheumatology · 2021
    Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors.

B RupPfizer, Immunogenicity Sciences Disciple, Pharmacokinetics, Dynamics and Metabolism.
M PallardyINSERM, UMR996, Faculté Pharmacie, Université Paris Sud, France.
D SikkemaGlaxoSmithKline, Clinical Immunology-Biopharm, King of Prussia, PA, USA.
T AlbertInstitute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany.
M AllezHôpital Saint-Louis, Department of Gastroenterology, GETAID, Paris, France.
P BroetINSERM, UMR669, University of Paris Sud, France.
C CariniPfizer, Early Biotech Clinical Development, Cambridge, MA, USA.
P CreekeCentre for Neuroscience and Trauma, Blizard Institute, Queen Mary University of London, London, UK.
J DavidsonGlaxoSmithKline, Worldwide Epidemiology, Southall, UK.
N De VriesClinical Immunology and Rheumatology, University of Amsterdam, Amsterdam, the Netherlands.
D FincoPfizer, Drug Safety R&D, Groton, CT, USA.
A Fogdell-HahnDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
E HavrdovaDepartment of Neurology and Center for Clinical Neuroscience, MS Center, Charles University in Prague, Prague, Czech Republic.
A Hincelin-MerySanofi-Aventis, Clinical Exploratory and Pharmacology, Chilly-Mazerin, FR.
M C HollandGlaxoSmithKline, Clinical Immunology-Biopharm R&D, King of Prussia, PA, USA.
P E H JensenDepartment of Neurology, University of Copenhagen, Copenhagen, Denmark.
E C JuryCentre for Rheumatology, University College London, London, UK.
H KirbyUCB Pharma, Bioanalytical R&D, Slough, UK.
D KramerMerck-Serono, Institute of Drug Metabolism and Pharmacokinetics, Grafing, Germany.
S Lacroix-DesmazesINSERM, UMR S 1138, Université Pierre et Marie Curie, Paris, France.
J LegrandIpsen Innovation, Pharmacokinetics Drug Metabolism Department, Les Ulis, France.
E MaggiDipartimento di Medicina Sperimentale e Clinica, Universita di Firenze, Firenze, Italy.
B MaillèreCEA-Saclay Institute of Biology and Technologies, Gif sur Yvette, France.
X MarietteINSERM, U1012, Hôpitaux Universitaires Paris Sud, Rhumatologie, Paris, France.
C MauriCentre for Rheumatology Research, University College London, London, UK.
V MikolSanofi Aventis, Structural Biology, Paris, France.
D MullemanUniversity of Tours Francois Rabelais, CNRS UMR 7292, Tours, France.
J OldenburgInstitute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany.
G PaintaudCNRS UMR 7292 'GICC', Faculty of Medicine, Tours, France.
C R PedersenNovo Nordisk, Immunogenicity, Måløv, Denmark.
N RupertoIstituto Giannina Gaslini, Pediatria II, Rheumatology, Genova, Italy.
R SeitzDivision of Haematology/Transfusion Medicine, Paul-Ehrlich-Institut, Langen, Germany.
S SpindeldreherDrug Metabolism Pharmacokinetics-Biologics, Novartis Institutes for Biomedical Research, Basel, Switzerland.
F DeisenhammerDepartment of Neurology, Innsbruck Medical University, Innsbruck, Austria.
ABIRISK Consortium

Funding

Arthritis Research UK 19314Versus Arthritis 17707Versus Arthritis 20085
6 · The paper itself

Abstract

Biopharmaceuticals (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).

Indexed as

Terminology as TopicAllergy and ImmunologyDrug HypersensitivityDrug IndustryDrugs, InvestigationalGuidelines as TopicHumansOrganizational InnovationOrganizational PolicyReference StandardsDrugs, InvestigationalABIRISK consortiumanti-drug antibodiesbiopharmaceuticalsimmunogenicity

Identifiers

PMID25959571
PMCPMC4557374

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.