ReviewThe AAPS journal2012
Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy.
Review in The AAPS journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 159 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
159 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Population Pharmacokinetic/Pharmacodynamic Modeling of Therapeutic Enzymes in Lysosomal Storage Diseases.Clinical pharmacokinetics · 2026Pooled it
- Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.The AAPS journal · 2014Guideline
- Pooled it
- Characterization of the VHH-Fc construct rimteravimab in healthy adults and patients hospitalized for mild-to-moderate COVID-19: Two Phase 1 randomized clinical trials.PLoS medicine · 2026Trial
- No Effect of Immunogenicity on Pharmacokinetics, Efficacy, and Safety of the Oligonucleotide Telomerase Inhibitor Imetelstat in Lower-Risk Myelodysplastic Syndromes.Clinical and translational science · 2025Trial
- Population Pharmacokinetics and Exposure-Response Relationships of Etrolizumab in Patients with Moderately-to-Severely Active Crohn's Disease.Journal of clinical pharmacology · 2025Trial
- Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY).Journal of Crohn's & colitis · 2025Trial
- Effect of E7777 Immunogenicity on Pharmacokinetics, Efficacy, and Safety in Adult Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma.Clinical and translational science · 2025Trial
- Pharmacokinetics and Exposure-Response of Vosoritide in Children with Achondroplasia.Clinical pharmacokinetics · 2022Trial
- Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria.Clinical and translational science · 2021Trial
- Anti-IL-7 receptor α monoclonal antibody (GSK2618960) in healthy subjects - a randomized, double-blind, placebo-controlled study.British journal of clinical pharmacology · 2019Trial
- Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials.EBioMedicine · 2018Trial
- Andecaliximab [Anti-matrix Metalloproteinase-9] Induction Therapy for Ulcerative Colitis: A Randomised, Double-Blind, Placebo-Controlled, Phase 2/3 Study in Patients With Moderate to Severe Disease.Journal of Crohn's & colitis · 2018Trial
- Calculating Receptor Occupancy using TMDD Models - What has to be Considered?The AAPS journal · 2026Article
- Amphibian Skin-Derived Peptides as Emerging Therapeutic Scaffolds for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).Pharmaceuticals (Basel, Switzerland) · 2026Review
- Evaluation of a Therapeutic Drug Monitoring Strategy for Adalimumab in Psoriasis: A Prospective Pharmacokinetic-Pharmacodynamic Study.Clinical and translational science · 2026Observational
- Integrative structural insights into the IgG-FcRn interactions revealed by engineered FcRn-immobilized affinity chromatography.Communications biology · 2026Article
- In Vivo Clearance of Immune Complexes: Insights Into Human Drug/Anti-Drug Antibody Complex Clearance Dynamics.The AAPS journal · 2026Article
- Pharmacokinetic profiling of rituximab in glomerular diseases: key determinants and implications for personalized therapy.Frontiers in pharmacology · 2026Review
- Anti-emicizumab antibodies and their relevance in clinical practice.Research and practice in thrombosis and haemostasis · 2026Article
99 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The development of therapeutic proteins requires the understanding of the relationship between the dose, exposure, efficacy, and toxicity of these molecules. Several intrinsic and extrinsic factors contribute to the challenges for measuring therapeutic proteins in a precise and accurate manner. In addition, induction of an immune response to therapeutic protein results in additional complexities in the analysis of the pharmacokinetic profile, toxicity, safety, and efficacy of this class of molecules. Assessment of immunogenicity of therapeutic proteins is a required aspect of regulatory filings for a licensing application and for the safe and efficacious use of these compounds. A systematic strategy and well-defined criteria for measuring anti-drug antibodies (ADA) have been established, to a large extent, through coordinated efforts. These recommendations are based on risk assessment and include the determination of ADA content (concentration/titer), affinity, immunoglobulin isotype/subtype, and neutralization capacity. This manuscript reviews the requirements necessary for understanding the nature of an ADA response in order to discern the impact of immunogenicity on pharmacokinetics/pharmacodynamics and efficacy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.