ReviewBritish journal of pharmacology2012
Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets.
Review in British journal of pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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
20 citing papers in PubMed.
- Application of new approach methodologies for nonclinical safety assessment of drug candidates.Nature reviews. Drug discovery · 2025Review
- Myasthenia Gravis Treatment: From Old Drugs to Innovative Therapies with a Glimpse into the Future.CNS drugs · 2024Review
- Accurate clinical toxicity prediction using multi-task deep neural nets and contrastive molecular explanations.Scientific reports · 2023Article
- An Anti-hTNF-α Variable New Antigen Receptor Format Demonstrates SuperiorFrontiers in immunology · 2019Article
- Monovalent TNF receptor 1-selective antibody with improved affinity and neutralizing activity.mAbs · 2019Article
- First Infusion Reactions are Mediated by FcγRIIIb and Neutrophils.Pharmaceutical research · 2018Article
- Review
- Development and Role in Therapy of Canakinumab in Adult-Onset Still's Disease.Frontiers in pharmacology · 2018Article
- Constitutive smooth muscle tumour necrosis factor regulates microvascular myogenic responsiveness and systemic blood pressure.Nature communications · 2017Article
- Use of nonhuman primates in obstructive lung disease research - is it required?Primate biology · 2017Review
- Article
- Review
- Clinical Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies Approved to Treat Rheumatoid Arthritis.Clinical pharmacokinetics · 2015Review
- Biosimilars entering the clinic without animal studies. A paradigm shift in the European Union.mAbs · 2014Article
- Inhibition of the inflammatory cytokine tumor necrosis factor-alpha with etanercept provides protection against lethal H1N1 influenza infection in mice.Critical care (London, England) · 2013Article
- Challenges and approaches for the development of safer immunomodulatory biologics.Nature reviews. Drug discovery · 2013Review
- Safety immunopharmacology: evaluation of the adverse potential of pharmaceuticals on the immune system.Journal of pharmacological and toxicological methods · 2012Article
- The successes and limitations of preclinical studies in predicting the pharmacodynamics and safety of cell-surface-targeted biological agents in patients.British journal of pharmacology · 2012Article
- Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets.British journal of pharmacology · 2012Review
- Systemic lupus erythematosus in Crohn's disease: drug-induced or idiopathic?Annals of gastroenterologyArticle
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monoclonal antibodies (mAbs) and fusion proteins directed towards soluble targets make an important contribution to the treatment of disease. The purpose of this review was to correlate the clinical and preclinical data on the 14 currently approved mAbs and fusion proteins targeted to soluble targets. The principal sources used to gather data were: the peer reviewed Literature; European Medicines Agency 'Scientific Discussions' and United States Food and Drug Administration 'Pharmacology/Toxicology Reviews' and package inserts (United States Prescribing Information). Data on the following approved biopharmaceuticals were included: adalimumab, anakinra, bevacizumab, canakinumab, certolizumab pegol, denosumab, eculizumab, etanercept, golimumab, infliximab, omalizumab, ranibizumab, rilonacept and ustekinumab. Some related biopharmaceuticals in late-stage development were also included for comparison. Good concordance with human pharmacodynamics was found for both non-human primates (NHPs) receiving the human biopharmaceutical and mice receiving rodent homologues (surrogates). In contrast, there was limited concordance for human adverse effects in genetically deficient mice, mice receiving surrogates or NHPs receiving the human pharmaceutical. In summary, the results of this survey show that although both mice and NHPs have good predictive value for human pharmacodynamics, neither species have good predictive value for human adverse effects. No evidence that NHPs have superior predictive value was found.
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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.