Evidence map›Paper›PMID 29314183›Full record

ArticleBritish journal of clinical pharmacology2018

Fixed dosing of intravenous tocilizumab in rheumatoid arthritis. Results from a population pharmacokinetic analysis.

Carla Bastida, Virginia Ruiz-Esquide, Mariona Pascal, Aurelia H M de Vries Schultink, Jordi Yagüe, Raimon Sanmartí, Alwin D R Huitema, Dolors Soy

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03895879 (Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% of its field
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.

NCT03895879 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)

TypeinterventionalSponsorReade Rheumatology Research InstituteRan2020 to 2024Enrolled98ConditionsRheumatoid ArthritisArmsTocilizumab
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Drug dosing in hospitalized obese patients with COVID-19.Critical care (London, England) · 2022
    Review
  9. Review
  10. Article
  11. Article
  12. Observational
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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

8 authors at 3 institutions in 2 countries.

Carla BastidaPharmacy Department, Division of Medicines, Hospital Clinic Barcelona, Universitat de Barcelona, Spain.ORCID 0000-0003-0845-8107
Virginia Ruiz-EsquideArthritis Unit, Rheumatology Department, Hospital Clinic Barcelona, Universitat de Barcelona, Spain.
Mariona PascalImmunology Department, CDB, Hospital Clinic Barcelona, Universitat de Barcelona, Spain.
Aurelia H M de Vries SchultinkDepartment of Pharmacy & Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Jordi YagüeImmunology Department, CDB, Hospital Clinic Barcelona, Universitat de Barcelona, Spain.
Raimon SanmartíArthritis Unit, Rheumatology Department, Hospital Clinic Barcelona, Universitat de Barcelona, Spain.
Alwin D R HuitemaDepartment of Pharmacy & Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Dolors SoyPharmacy Department, Division of Medicines, Hospital Clinic Barcelona, Universitat de Barcelona, Spain.
Hospital Clínic de Barcelona · ESThe Netherlands Cancer Institute · NLUtrecht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsIntravenous tocilizumab is currently dosed on body weight, although a weak correlation between body weight and clearance has been described. The aim of the study was to assess the current dosing strategy and provide a scientific rational for dosing using a modelling and simulation approach.

methodsSerum concentrations and covariates were obtained from intravenous tocilizumab treated subjects at a dose of 4, 6 or 8 mg every 28 days. A population pharmacokinetic analysis was performed using nonlinear mixed effects modelling. The final model was used to simulate tocilizumab exposure to assess a dosing strategy based on body weight or fixed dosing, using as target a cumulative area under the curve at 24 weeks of treatment above 100 × 10

resultsA one-compartment disposition model with parallel linear and nonlinear elimination best described the concentration-time data. The typical population mean values for clearance, apparent volume of distribution, maximum elimination rate and Michaelis-Menten constant were 0.0104 l h

conclusionsOur study provides evidence to support fixed dosing of intravenous tocilizumab in rheumatoid arthritis patients since it reduces variability in tocilizumab exposure among weight categories compared to the current weight-based dosing approach.

Indexed as

Models, BiologicalAdministration, IntravenousAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidBody WeightComputer SimulationC-Reactive ProteinDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedNonlinear DynamicsAntibodies, Monoclonal, HumanizedAntirheumatic AgentsC-Reactive Proteintocilizumabbody weightfixed dosingmonoclonal antibodiespopulation pharmacokineticsrheumatoid arthritistocilizumab

Identifiers

PMID29314183
PMCPMC5867112
OpenAlexW2783051410

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.