Evidence map›Paper›PMID 34352114›Full record

ArticleJournal of clinical pharmacology2022

Population Pharmacokinetics and Pharmacodynamics of Burosumab in Adult and Pediatric Patients With X-linked Hypophosphatemia.

Sun Ku Lee, Nathalie H Gosselin, Julie Taylor, Mary Scott Roberts, Kathleen McKeever, Jack Shi

Open access · hybridAbstract read
In one paragraph

Article in Journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

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

7 citing papers in PubMed, 9 citations in OpenAlex.

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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

6 authors at 2 institutions in 1 country.

Sun Ku LeeUltragenyx Pharmaceutical Inc., Novato, California, USA.
Nathalie H GosselinCertara Strategic Consulting, Princeton, New Jersey, USA.
Julie TaylorUltragenyx Pharmaceutical Inc., Novato, California, USA.
Mary Scott RobertsUltragenyx Pharmaceutical Inc., Novato, California, USA.
Kathleen McKeeverUltragenyx Pharmaceutical Inc., Novato, California, USA.
Jack ShiUltragenyx Pharmaceutical Inc., Novato, California, USA.
Ultragenyx Pharmaceutical (United States) · USIntegra LifeSciences (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Burosumab is a fully human monoclonal antibody against fibroblast growth factor 23, which has been approved to treat X-linked hypophosphatemia (XLH) in adult and pediatric patients. The present work describes the pharmacokinetics (PK) of burosumab and the pharmacokinetic-pharmacodynamic (PK-PD) relationship between burosumab and serum phosphorus in adult and pediatric patients with XLH. A total of 2844 measurable serum concentrations of burosumab and 6047 measurable serum concentrations of phosphorus in 277 subjects from 9 clinical studies were included in the population PK and PK-PD modeling. The serum concentration of burosumab following a subcutaneous administration was well described by a population PK model comprising a first-order absorption, 1-compartmental distribution, and a linear elimination. The relationship between serum burosumab and serum phosphorus was adequately described by a sigmoid maximal efficacy model. Body weight was the only covariate associated with PK and PK-PD parameters. No other intrinsic factors affected PK or PK-PD relationship in adult and pediatric patients with XLH. Further simulations helped to guide the dosing regimen of burosumab in adult and pediatric patients with XLH including age groups with no clinical data.

Indexed as

AdolescentAdultAgedAge FactorsAntibodies, Monoclonal, HumanizedBody WeightChildChild, PreschoolDose-Response Relationship, DrugFamilial Hypophosphatemic RicketsFemaleFibroblast Growth FactorsHumansInfantInjections, SubcutaneousMaleAntibodies, Monoclonal, HumanizedburosumabFibroblast Growth FactorsPhosphorusburosumabpharmacodynamicspharmacokineticsserum phosphorusX-linked hypophosphatemia

Identifiers

PMID34352114
PMCPMC9292737
OpenAlexW3190700859

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.