Evidence map›Paper›PMID 35464812›Full record

ArticleTherapeutic advances in musculoskeletal disease2022

Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol.

Megan Clowse, Rebecca Fischer-Betz, Catherine Nelson-Piercy, Angela E Scheuerle, Brigitte Stephan, Marla Dubinsky, Thomas Kumke, Rachna Kasliwal, Bernard Lauwerys, Frauke Förger

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 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

10 authors at 10 institutions in 5 countries.

Megan ClowseDivision of Rheumatology, Duke University Medical Center, 3535, Durham, NC 27710, USA.ORCID https://orcid.org/0000-0002-8579-3470
Rebecca Fischer-BetzDepartment for Rheumatology and Hiller Research Institute, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Catherine Nelson-PiercyDepartment of Women and Children's Health, Guy's and St Thomas' Hospital, London, UK.
Angela E ScheuerleDepartment of Pediatrics, Division of Genetics and Metabolism, UT Southwestern Medical Center, Dallas, TX, USA.
Brigitte StephanInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Marla DubinskyThe Susan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.
Thomas KumkeUCB Pharma, Monheim am Rhein, Germany.
Rachna KasliwalUCB Pharma, Slough, UK.
Bernard LauwerysUCB Pharma, Brussels, Belgium.
Frauke FörgerDepartment of Rheumatology and Immunology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.
Duke Medical Center · USHeinrich Heine University Düsseldorf · DEMount Sinai Hospital · USSouthwestern Medical Center · USSt Thomas' Hospital · GBUCB Pharma (Belgium) · BEUCB Pharma (Germany) · DEUCB Pharma (United Kingdom) · GBUniversität Hamburg · DEUniversity of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Chronic inflammatory diseases (CIDs), including rheumatic diseases and other inflammatory conditions, often affect women of reproductive age. Tumor necrosis factor inhibitors (TNFi) are widely used to treat CID, but there is limited information on outcomes of TNFi-exposed pregnancies. We evaluated pregnancy outcomes from 1392 prospectively reported pregnancies exposed to certolizumab pegol (CZP), a PEGylated, Fc-free TNFi with no to minimal placental transfer. Methods: CZP-exposed pregnancies in patients with CID from the UCB Pharmacovigilance global safety database were reviewed from the start of CZP clinical development (July 2001) to 1 November 2020. To limit bias, the analysis focused on prospectively reported cases with known pregnancy outcomes. Results: In total, 1392 prospective pregnancies with maternal CZP exposure and known pregnancy outcomes ( Discussion and conclusion: No signal for adverse pregnancy outcomes or congenital malformations was observed in CZP-exposed pregnancies. Although the limitations of data collected through this methodology (including underreporting, missing information, and absence of a comparator group) should be considered, these data provide reassurance for women with CID who require CZP treatment during pregnancy, and their treating physicians.

Indexed as

certolizumab pegolcongenital malformationinfantmiscarriagepregnanciespreterm birthTNFi

Identifiers

PMID35464812
PMCPMC9023886
OpenAlexW4226132759

What OpenQuestion holds

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LicenceCC BY-NC
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.