Evidence map›Paper›PMID 34313019›Full record

SynthesisCPT: pharmacometrics & systems pharmacology2021

Population pharmacokinetic analysis of dupilumab in adult and adolescent patients with asthma.

Li Zhang, Yue Gao, Meng Li, Christine Xu, John D Davis, Vanaja Kanamaluru, Qiang Lu

Abstract readMeta-Analysis
In one paragraph

Synthesis in CPT: pharmacometrics & systems pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
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

7 authors.

Li ZhangSanofi, Bridgewater, New Jersey, USA.
Yue GaoSanofi, Bridgewater, New Jersey, USA.
Meng LiSanofi, Bridgewater, New Jersey, USA.
Christine XuSanofi, Bridgewater, New Jersey, USA.
John D DavisRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Vanaja KanamaluruSanofi, Bridgewater, New Jersey, USA.
Qiang LuSanofi, Bridgewater, New Jersey, USA.

Funding

Regeneron Pharmaceuticals, Inc.Sanofi
6 · The paper itself

Abstract

A population pharmacokinetic model was developed using data from healthy subjects and patients with moderate-to-severe asthma receiving intravenous or subcutaneous dupilumab doses. A total of nine phase I to phase III studies were pooled (202 healthy subjects and 1912 patients with asthma including 68 adolescents) in the model development. The best model was a two-compartment model with parallel linear and nonlinear Michaelis-Menten elimination with first order absorption. The PK parameter estimates were distribution volume of central compartment 2.76 L, linear elimination rate 0.0418 1/day, and subcutaneous bioavailability 60.9%. Pharmacokinetics (PK) properties of dupilumab in patients with asthma were determined to be comparable to those of healthy subjects and patients with atopic dermatitis. Only body weight exerts a notable effect explaining between-subject variability in dupilumab PK, but dose adjustment for weight is not warranted based on results from clinical studies. There is no PK difference between adolescent and adult patients with asthma after correction for body weight.

Indexed as

Models, BiologicalAdministration, IntravenousAdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAsthmaBiological AvailabilityCase-Control StudiesChildClinical Trials, Phase I as TopicClinical Trials, Phase III as TopicDermatitis, AtopicFemaleHumansAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID34313019
PMCPMC8376131

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.