ReviewClinical & translational immunology2015
Clinical development methodology for infusion-related reactions with monoclonal antibodies.
Review in Clinical & translational immunology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 2 of them syntheses that pooled it.
What it found
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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
61 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Infusion-Related Reactions Among Cancer Patients Receiving Immune Checkpoint Inhibitors: The ARON-MOUSEION-013 Systematic Review and Meta-Analysis.Drug design, development and therapy · 2025Pooled it
- Non-allergic Hypersensitivity Reactions to Immunoglobulin Preparations in Antibody Deficiencies: What Role for Anti-IgA IgG and Complement Activation?Clinical reviews in allergy & immunology · 2024Pooled it
- Comparing the Risk of Infusion-Related Reactions and Tolerability in Patients Given Cetirizine or Diphenhydramine Prior to Ocrelizumab Infusion (PRECEPT).Medicina (Kaunas, Lithuania) · 2024Trial
- Severe bradycardia after amivantamab administration in a patient with epidermal growth factor receptor-positive non-small cell lung cancer: A case report.Fujita medical journal · 2026Article
- Article
- Safety and Efficacy of Mosunetuzumab: Experience in the Hospital Cardinale Giovanni Panico.Antibodies (Basel, Switzerland) · 2026Article
- Lecanemab appropriate use recommendations for clinical practice in the UK.Journal of neurology, neurosurgery, and psychiatry · 2026Review
- Immediate and delayed hypersensitivity to biologicals in children-A practical approach: An EAACI task force report.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026Review
- Evolocumab-Induced Angioedema: First Documented Case and Review of a Rare Adverse Event.JACC. Case reports · 2026Article
- Comprehensive Study of Drug-Associated Severe Allergic Reactions: An Analysis of High-Risk Medications and Epidemiological Trends Based on the FAERS Database.Allergy, asthma & immunology research · 2026Article
- Immunocytokines in cancer: a safety perspective.Frontiers in immunology · 2026Review
- A Comprehensive Analysis of Adverse Events Associated with HER2 Inhibitors Approved for Breast Cancer Using the FDA Adverse Event Report System (FAERS).Pharmaceuticals (Basel, Switzerland) · 2025Article
- Management of hypersensitivity in a patient with late-onset Pompe disease experiencing recurrent infusion-related reactions.Journal of neurology · 2025Article
- Comparative inhibitory effects of bepotastine and diphenhydramine on rituximab-induced infusion reactions.International journal of hematology · 2025Article
- The Evolution of Anti-CD20 Treatment for Multiple Sclerosis: Optimization of Antibody Characteristics and Function.CNS drugs · 2025Review
- Donanemab: Appropriate use recommendations.The journal of prevention of Alzheimer's disease · 2025Article
- Article
- Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform.Frontiers in immunology · 2025Review
- Cytokine release syndrome induced by immune checkpoint inhibitor treatment for uterine cervical cancer recurrence: A case report.Oncology letters · 2024Article
- Reversible Chemical Modification of Antibody Effector Function Mitigates Unwanted Systemic Immune Activation.Bioconjugate chemistry · 2024Article
1 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
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Infusion-related reactions (IRRs) are common with monoclonal antibodies (mAbs) and timely related to drug administration and have been reported as anaphylaxis, anaphylactoid reactions and cytokine release syndrome, among other terms used. We address risk management measures for individual patients and for the study and propose a consistent reporting approach in an attempt to allow cross-molecule comparisons. Once the symptoms of IRR have resolved, the mAb may be restarted. Rechallenge should not be done for suspected IgE-mediated anaphylaxis and Grade 4 IRRs. Management of IRRs for subsequent patients includes administration of premedication, which, however, does not prevent IgE-mediated anaphylaxis. Reporting approach: (1) Report as IRRs, reactions occurring during or within 24 h after an infusion. Negative skin Prick test and absent or undetectable allergen-specific IgE levels have high negative predictive value for an IgE-mediated allergic reaction. If IgE-mediated anaphylaxis is suspected based on medical history and/or laboratory test results, the reaction should be reported as suspected (IgE mediated) anaphylaxis. (2) Collect signs and symptoms with grades to allow characterization of IRRs. IRRs pathogenesis is of scientific interest and has impact on drug development. Animal toxicology studies are neither predictive of severe IRRs nor of anaphylaxis in human. Preclinical tests should be further developed to identify patients at risk for severe IRRs, for complement activation-related pseudoallergy and for IgE-mediated anaphylaxis. The proposed approach should help standardizing data collection and analysis of IRRs in an attempt to enable comparisons across molecules.
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.