Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study.
Aliment Pharmacol Ther
; 51(1): 129-138, 2020 01.
Article
em En
| MEDLINE
| ID: mdl-31692017
ABSTRACT
BACKGROUND:
Women with inflammatory bowel diseases (IBD) often receive biologicals during pregnancy to maintain disease remission. Data on outcome of vedolizumab-exposed pregnancies (VDZE) are sparse.AIMS:
To assess pregnancy and child outcomes of VDZE pregnancies and to compare these results to anti-TNF exposed (TNFE) or both immunomodulatory and biologic unexposed (CON IBD) pregnancies.METHODS:
A retrospective multicentre case-control observational study was performed.RESULTS:
VDZE group included 79 pregnancies in 73 IBD women. The TNFE and CON IBD group included 186 pregnancies (162 live births) in 164 IBD women and 184 pregnancies (163 live births) in 155 IBD women, respectively. At conception, cases more often had active disease ([VDZE 36% vs TNFE 17%, P = .002] and [VDZE 36% vs CON IBD 24%, P = .063]). No significant difference in miscarriage rates were found between groups (VDZE and TNFE 16% vs 13%, P = .567; VDZE and CON IBD 16% vs 10%, P = .216). In live-born infants, median gestational age and birthweight were similar between groups. Median Apgar score at birth was numerically equal. Prematurity was similar in the VDZE group compared to the control groups, even when correcting for disease activity during pregnancy. The frequency of congenital anomalies was comparable between groups as were the percentages of breastfed babies. During the first year of life, no malignancies were reported and infants' infection risk did not significantly differ between groups.CONCLUSION:
No new safety signal was detected in VDZE pregnancies although larger, prospective studies are required for confirmation.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Complicações na Gravidez
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Resultado da Gravidez
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Doenças Inflamatórias Intestinais
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Anticorpos Monoclonais Humanizados
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Fatores Imunológicos
Tipo de estudo:
Observational_studies
/
Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Infant
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Male
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Newborn
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Pregnancy
País/Região como assunto:
Europa
Idioma:
En
Revista:
Aliment Pharmacol Ther
Assunto da revista:
FARMACOLOGIA
/
GASTROENTEROLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Bélgica