Evidence map›Paper›PMID 34514598›Full record

Trial reportClinical pharmacology and therapeutics2021

Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID-19 Infection.

Emmanuel Chigutsa, Lisa O'Brien, Lisa Ferguson-Sells, Amanda Long, Jenny Chien

Abstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Serum AZD7442 (tixagevimab-cilgavimab) concentrations andClinical & translational immunology · 2024
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Immune-based therapeutic approaches in COVID-19.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2022
    Review
  17. Review
  18. Article
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

5 authors.

Emmanuel ChigutsaGlobal PK/PD & Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.
Lisa O'BrienGlobal PK/PD & Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.
Lisa Ferguson-SellsGlobal PK/PD & Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.
Amanda LongGlobal PK/PD & Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.
Jenny ChienGlobal PK/PD & Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

Bamlanivimab and etesevimab are neutralizing antibodies indicated for treatment of coronavirus disease 2019 (COVID-19) in patients with early mild or moderate disease. We present the use of pharmacokinetic/pharmacodynamic (PK/PD) modeling that characterizes the timecourse of viral load obtained from 2,970 patients from 2 phase II clinical trials. The model was used for identification of optimal doses that would result in at least 90% of patients achieving serum drug concentrations that result in 90% of maximum drug effect (IC90) for at least 28 days. The serum IC90 (95% confidence interval) was estimated to be 4.2 (3.2-4.3) µg/mL for bamlanivimab and 12.6 (9.7-12.8) µg/mL for etesevimab. Observed clinical trial data confirmed PK and PK/PD model predictions that doses of 700 mg bamlanivimab and 1,400 mg etesevimab would result in maximum reduction in viral load, with no additional effect seen at higher doses. No dose adjustment is recommended as age, sex, race, baseline viral load, and hepatic impairment did not have a significant impact on the PK of the antibodies. Earlier drug administration resulted in greater reductions in viral load, demonstrating the importance of receiving treatment as soon as possible. Relative to placebo, typical reduction in viral load over a 7-day period was estimated to be 80 or 93% (drug administered 4 days or 1 day after the onset of symptoms, respectively), P < 0.0001. PK/PD modeling and simulation was pivotal throughout the drug development and emergency use authorization process.

Indexed as

COVID-19 Drug TreatmentAdministration, IntravenousAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntiviral AgentsBody WeightCOVID-19Double-Blind MethodDrug CombinationsDrug Therapy, CombinationHumansModels, TheoreticalPopulationTime FactorsViral LoadAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntiviral Agentsbamlanivimabbamlanivimab and etesevimab drug combinationDrug Combinationsetesevimab

Identifiers

PMID34514598
PMCPMC8652670

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Registered trials

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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.