Trial reportInternational journal of clinical pharmacology and therapeutics2013
Pharmacokinetics and pharmacodynamics of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, following single-dose administration by subcutaneous and intravenous routes to healthy subjects.
Trial report in International journal of clinical pharmacology and therapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis 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
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Effect of subcutaneous vs. intravenous tocilizumab in patients with severe COVID-19: a systematic review.European journal of clinical pharmacology · 2024Pooled it
- Safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WBP216, a novel IL-6 monoclonal antibody, in patients with rheumatoid arthritis: A phase Ia randomized placebo-controlled study.Frontiers in immunology · 2022Trial
- A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (ActemraAnnals of medicine · 2021Trial
- Subcutaneous tocilizumab in adults with severe and critical COVID-19: A prospective open-label uncontrolled multicenter trial.International immunopharmacology · 2020Trial
- Subcutaneous tocilizumab alone or with a csDMARD in rheumatoid arthritis patients: subanalysis of Italian data from a multicenter phase IIIb/IV trial.Clinical rheumatology · 2019Trial
- Short-term application of tocilizumab during myocardial infarction (STAT-MI).Rheumatology international · 2018Trial
- Mechanism-based approach using a biomarker response to evaluate tocilizumab subcutaneous injection in patients with rheumatoid arthritis with an inadequate response to synthetic DMARDs (MATSURI study).Journal of clinical pharmacology · 2014Trial
- Subcutaneous Versus Intravenous Tocilizumab in Aortitis Associated With Giant Cell Arteritis: Multicenter Study of 196 Patients.Arthritis care & research · 2026Observational
- A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product.Rheumatology and therapy · 2025Article
- Modeling the subcutaneous pharmacokinetics of antibodies co-administered with rHuPH20.Clinical and translational science · 2024Article
- Mitigating target interference challenges in bridging immunogenicity assay to detect anti-tocilizumab antibodies.Bioanalysis · 2024Article
- The Combination of a Human Biomimetic Liver Microphysiology System with BIOLOGXsym, a Quantitative Systems Toxicology (QST) Modeling Platform for Macromolecules, Provides Mechanistic Understanding of Tocilizumab- and GGF2-Induced Liver Injury.International journal of molecular sciences · 2023Article
- Tocilizumab for Severe COVID-19 Infection and Multisystem Inflammatory Syndrome in Adults and Children.Life (Basel, Switzerland) · 2023Review
- Comparison of Anakinra and Tocilizumab in Anticytokine Therapy in the Treatment of Coronavirus Disease-2019.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2022Article
- Determination of the Monoclonal Antibody Tocilizumab by a Validated Micellar Electrokinetic Chromatography Method.Chromatographia · 2022Article
- Tocilizumab reduces COVID-19 mortality and pathology in a dose and timing-dependent fashion: a multi-centric study.Scientific reports · 2021Article
- Herpes Simplex Virus Re-Activation in Patients with SARS-CoV-2 Pneumonia: A Prospective, Observational Study.Microorganisms · 2021Article
- The effects of targeted immune-regulatory strategies on tumor-specific T-cell responses in vitro.Cancer immunology, immunotherapy : CII · 2021Article
- The Role of Convalescent Plasma and Tocilizumab in the Management of COVID-19 Infection: A Cohort of 110 Patients from a Tertiary Care Hospital in Oman.Journal of epidemiology and global health · 2021Article
- Immunomodulation for the management of severe SARS-CoV2 infections. State of the art and review of the literature.Biochemical and biophysical research communications · 2021Review
Corrections and comments
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Authors and funding
3 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTocilizumab, a humanized anti-interleukin-6 receptor (IL-6R) monoclonal antibody, given by intravenous (i.v.) infusion every 4 weeks has been approved for treatment of patients with rheumatoid arthritis. The objective of the study was to determine pharmacokinetics (PK) and pharmacodynamics (PD) of tocilizumab including absolute PK and PD bioavailabilities following subcutaneous (s.c.) administration.
methodsThe PK and PD of tocilizumab 162 mg or 81 mg after single s.c. and i.v. administration were evaluated in an open-label, 4-parallel group study involving 48 healthy subjects (n = 12/group).
resultsFollowing single-dose s.c. administration of tocilizumab, area under the serum concentration-time curve (AUC∞) increased by 6.4-fold, and maximum serum concentration (Cmax) increased by 4-fold, as the dose was doubled from 81 mg to 162 mg. Tocilizumab absolute PK bioavailability (AUC∞ ratio (s.c./i.v.)) was higher at 162 mg (48.8%) than at 81 mg (22.7%). Tocilizumab PD bioavailability for soluble IL-6R (sIL-6R) (AUClast ratio (s.c./i.v.)) was 109% at 162 mg and 80.9% at 81 mg. Tocilizumab PD bioavailability for C-reactive protein (CRP) effect was 98.2% (CRP AUC480h ratio) at 162 mg and 80.4% (AUC240h ratio (s.c./i.v.)) at 81 mg. Tocilizumab was well tolerated at both doses after s.c. and i.v. administration.
conclusionsTocilizumab absolute PK bioavailability for s.c. vs. i.v. administration was low; however, the PD effects for sIL-6R and CRP levels were comparable after 162-mg s.c. and i.v. administration. Therefore, 162 mg s.c. dose is a comparable dose for 162 mg i.v. dose based on PD bioavailability.
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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.