Evidence map›Paper›PMID 29030361›Full record

Trial reportAnnals of the rheumatic diseases2018

Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study.

Xavier Mariette, Frauke Förger, Bincy Abraham, Ann D Flynn, Anna Moltó, René-Marc Flipo, Astrid van Tubergen, Laura Shaughnessy, Jeff Simpson, Marie Teil and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. 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 151 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 7 pooled it
33.5field-weighted citation impact, top 1% 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.

NCT02019602 phase1completednot on this map

A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)

TypeinterventionalSponsorUCB BIOSCIENCES, Inc.Ran2014 to 2016Enrolled37ConditionsAxial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's DiseaseArmsBlood sampling from mother, Blood sampling from infant, Blood sampling from umbilical cord, Certolizumab Pegol
NCT04569890 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China

TypeinterventionalSponsorRenJi HospitalRan2020 to 2023Enrolled100ConditionsRheumatoid Arthritis, Pregnancy RelatedArmsCertolizumab Pegol 200 MG/ML [Cimzia], Hydroxychloroquine, Prednisone
3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 7 syntheses or guidelines pooled it, 381 citations in OpenAlex.

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91 more citing papers are in PubMed but not listed here.

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

13 authors at 11 institutions in 6 countries.

Xavier MarietteUniversité Paris-Sud, Hôpitaux Universitaires Paris-Sud, INSERM, Le Kremlin-Bicêtre, France.
Frauke FörgerInselspital, University Hospital and University of Bern, Bern, Switzerland.
Bincy AbrahamHouston Methodist Hospital, Houston, Texas, USA.
Ann D FlynnUniversity of Utah Health, Salt Lake City, Utah, USA.
Anna MoltóDepartment of Rheumatology, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, INSERM, Paris, France.ORCID 0000-0003-2246-1986
René-Marc FlipoCentre Hospitalier Regional Universitaire de Lille, Lille, Nord-Pas-de-Calais, France.
Astrid van TubergenDepartment of Medicine, Division of Rheumatology and CAPHRI - Care and Public Health Research Institute Maastricht, Maastricht University Medical Center, Maastricht, Netherlands.
Laura ShaughnessyUCB Pharma, Raleigh, North Carolina, USA.
Jeff SimpsonUCB Pharma, Raleigh, North Carolina, USA.
Marie TeilUCB Pharma, Slough, UK.
Eric HelmerUCB Pharma, Brussels, Belgium.
Maggie WangUCB Pharma, Raleigh, North Carolina, USA.
Eliza F ChakravartyOklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.
UCB Pharma (United States) · USCentre Hospitalier Universitaire de Lille · FRInserm · FRMaastricht University · NLMethodist Hospital · USOklahoma Medical Research Foundation · USUCB Pharma (Belgium) · BEUCB Pharma (United Kingdom) · GBUniversité Paris-Sud · FRUniversity of Bern · CHUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThere is a need for effective and safe treatment during pregnancy in women with chronic inflammatory diseases. This study evaluated placental transfer of certolizumab pegol (CZP), an Fc-free anti-tumour necrosis factor drug, from CZP-treated pregnant women to their infants.

methodsCRIB was a pharmacokinetic (PK) study of women ≥30 weeks pregnant receiving commercial CZP for a locally approved indication (last dose ≤35 days prior to delivery). Blood samples were collected from mothers, umbilical cords and infants at delivery, and infants again at weeks 4 and 8 post-delivery. CZP plasma concentrations were measured with a highly sensitive and CZP-specific electrochemiluminescence immunoassay (lower limit of quantification 0.032 μg/mL).

resultsSixteen women entered and completed the study. Maternal CZP plasma levels at delivery were within the expected therapeutic range (median [range] 24.4 [5.0-49.4] μg/mL). Of the 16 infants, 2 were excluded from the per-protocol set: 1 due to missing data at birth and 1 due to implausible PK data. Of the remaining 14 infants, 13 had no quantifiable CZP levels at birth (<0.032 μg/mL), and 1 had a minimal CZP level of 0.042 μg/mL (infant/mother plasma ratio 0.0009); no infants had quantifiable CZP levels at weeks 4 and 8. Of 16 umbilical cord samples, 1 was excluded due to missing data; 3/15 had quantifiable CZP levels (maximum 0.048 μg/mL).

conclusionsThere was no to minimal placental transfer of CZP from mothers to infants, suggesting lack of TRIAL REGISTRATION NUMBER: NCT02019602; Results.

Indexed as

AdolescentAdultAntirheumatic AgentsAutoimmune DiseasesCertolizumab PegolFemaleFetal BloodHumansInfantInfant, NewbornLuminescent MeasurementsPlacentaPregnancyProduct Surveillance, PostmarketingProspective StudiesYoung AdultAntirheumatic AgentsCertolizumab Pegolanti-tnfpsoriatic arthritisrheumatoid arthritisspondyloarthritistreatment

Identifiers

PMID29030361
PMCPMC5867410
OpenAlexW2764022867

What OpenQuestion 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 OpenQuestion graph.