Evidence map›Paper›PMID 33149762›Full record

ArticleTherapeutic advances in gastroenterology2020

Safety of vedolizumab in the treatment of pregnant women with inflammatory bowel disease: a targeted literature review.

Birgit Terjung, Renate Schmelz, Robert Ehehalt, Jochen Klaus, Jana Knop, Sabine Schwind, Thomas Wilke, Andreas Stallmach

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.4field-weighted citation impact, top 16% 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

1 citing paper in PubMed, 9 citations in OpenAlex.

  1. Raising the bar in ulcerative colitis management.Therapeutic advances in gastroenterology · 2024
    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

8 authors at 7 institutions in 1 country.

Birgit TerjungDepartment of Internal Medicine - Gastroenterology, GFO Kliniken Bonn, Nordrhein-Westfalen, Germany.
Renate SchmelzMedical Department 1, University Hospital Dresden, TU Dresden, Germany.
Robert EhehaltGastroenterology Outpatient Clinic Heidelberg, Heidelberg, Germany.
Jochen KlausInnere Medizin I, Universitätsklinikum Ulm, Ulm, Germany.
Jana KnopTakeda Pharma Vertrieb GmbH & Co. KG, Berlin, Germany.
Sabine SchwindTakeda Pharma Vertrieb GmbH & Co. KG, Berlin, Germany.
Thomas WilkeInstitut für Pharmakoökonomie und Arzneimittellogistik (IPAM) an der Hochschule Wismar, Wismar, Germany.ORCID https://orcid.org/0000-0001-8932-6426
Andreas StallmachInnere Medizin IV (Gastroenterologie, Hepatologie und Infektiologie), Universitätsklinikum Jena, Am Klinikum 1, Jena 07743, Germany.
Takeda (Germany) · DEJena University Hospital · DESt. Marien-Hospital Bonn · DETechnische Universität Dresden · DEUniversity Hospital Heidelberg · DEUniversity Hospital Ulm · DEWismar University of Applied Sciences · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCrohn's disease (CD) and ulcerative colitis (UC) commonly affect women in their childbearing years. Vedolizumab (VDZ) is approved for treatment of moderate-to-severe CD and UC, but there is a knowledge gap regarding its use during pregnancy. This targeted literature review describes available evidence on safety of VDZ in pregnant patients in order to offer physicians a detailed and balanced view on persistent data during their decision-making process for an individualized treatment concept.

methodsThe search included literature from the MEDLINE database and abstracts of five gastroenterological conferences published until November 2019. Publications were included if pregnancy outcomes in women receiving VDZ or neonatal outcomes in newborns of women previously exposed to VDZ were reported.

resultsOut of 196 initially identified records, 18 publications reporting results of five different studies were identified. In total, for 213 of 284 VDZ-exposed documented pregnancies the following pregnancy outcomes were reported: 167 live births (172 infants due to twin births), 1 stillbirth, 35 miscarriages, 10 elective terminations (1 due to detected Down syndrome). Furthermore, during pregnancy, the following complications were observed: seven cases of (pre) eclampsia, three cases of premature rupture of membranes and one case each of placenta previa, chorioamnionitis, pneumonia, first-trimester bleeding, cholestasis, sepsis, or neonatal intraventricular hemorrhage. Based on 172 infants, 30 preterm deliveries (17.4%), 9 cases of low birth weight (5.2%), 5 infections (2.9%), and 6 cases (3.8%) with congenital anomalies were reported.

conclusionThere was no evidence for safety concerns regarding pregnancy outcomes associated with VDZ therapy. Due to the limited scope of included records, further research is needed to understand the safety profile regarding the use of VDZ during pregnancy.

Indexed as

inflammatory bowel diseasepregnancyvedolizumab

Identifiers

PMID33149762
PMCPMC7580131
OpenAlexW3092874882

What OpenQuestion holds

Textmetadata
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.