Evidence map›Paper›PMID 39219320›Full record

ArticleCPT: pharmacometrics & systems pharmacology2024

Population PK modeling of certolizumab pegol in pregnant women with chronic inflammatory diseases.

Denis Menshykau, Jagdev Sidhu, Laura Shaughnessy, Rocio Lledo-Garcia, Pinky Dua, Marie Teil, Akash Khandelwal

2 registry-linked trialsAbstract readClinical Trial, Phase I
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04163016 phase1completednot on this map

A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

TypeinterventionalSponsorUCB Biopharma SRLRan2020 to 2023Enrolled22ConditionsRheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Axial SpondyloarthritisArmsPharmacokinetics of certolizumab pegol
NCT04740814 phase1completednot on this map

A Multi-Center, Open-Label Study to Evaluate the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis Using an Electrochemiluminescent Immuno-Assay

TypeinterventionalSponsorUCB Biopharma SRLRan2021 to 2022Enrolled33ConditionsRheumatoid ArthritisArmsCertolizumab pegol
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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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

7 authors.

Denis MenshykauUCB Biosciences GmbH, Monheim am Rhein, Germany.
Jagdev SidhuUCB Australia Pty Ltd, Malvern, Victoria, Australia.
Laura ShaughnessyUCB BioSciences Inc, Raleigh, North Carolina, USA.
Rocio Lledo-GarciaUCB Pharma, Slough, UK.
Pinky DuaUCB Pharma, Slough, UK.
Marie TeilUCB Biopharma SRL, Brussels, Belgium.
Akash KhandelwalUCB Biosciences GmbH, Monheim am Rhein, Germany.ORCID 0000-0002-0472-7173

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Certolizumab pegol (CZP; CIMZIA™) is the only Fc-free tumor necrosis factor inhibitor with data from a clinical study demonstrating no to minimal placental transfer. The pharmacokinetics (PK) of certolizumab pegol during pregnancy and postpartum in women with chronic inflammatory diseases were assessed using a population PK model based on data from the CHERISH study (NCT04163016), a longitudinal, prospective, open-label PK phase IB study. Model development was performed in NONMEM using a frequentist prior approach, with prior information based on a population PK model for certolizumab pegol in non-pregnant adult patients (NCT04740814). A one-compartment model with first-order absorption (K

Indexed as

Certolizumab PegolModels, BiologicalPregnancy ComplicationsAdultChronic DiseaseFemaleHumansInflammationLongitudinal StudiesPostpartum PeriodPregnancyProspective StudiesYoung AdultCertolizumab Pegol

Identifiers

PMID39219320
PMCPMC11578139

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.