P519 Anti-tumour necrosis-alpha therapy during pregnancy in patients with inflammatory bowel disease: safety in women and children

Bernardes, Carlos; Loureiro, Rafaela; Carvalho, Diana; Borges, Verónica; Russo, Pedro; Saiote, Joana; Ramos, Jaime

doi:10.1093/ecco-jcc/jjx002.643

Cited by 2 publications

(8 citation statements)

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“…No relationship was found between concomitant thiopurine use and the prevalence of preterm birth in 21 studies reporting the number of participants receiving thiopurine 17,23,25,38,[41][42][43][45][46][47]50,54,56,58,59,61,[68][69][70][71]74 (slope, 0.067; 95% CI, -0.192 to 0.327). No relationship between the risk of preterm birth and the percentage of participants with disease activity at conception were identified in 20 studies 17,23,25,38,40,41,43,50,[53][54][55][56]58,59,62,64,65,68,69,74 (slope, 0.233; 95% CI, -0.134 to 0.601). The overall pooled prevalence of preterm birth was 9% (95% CI, 7%-11%; I 2 ¼ 89.9%) with biologics use in pregnancy, comparable with a rate of preterm birth of 10% in a cohort of 1960 women with IBD including active disease 81 and 11% in the background population.…”

Section: Preterm Birthmentioning

confidence: 97%

“…Subgroup analyses identified a significantly higher prevalence of EPL in patients exposed to VDZ (P ¼ .001) or UST (P < .001) compared with TNF inhibitors, although these data should be interpreted with caution because of limited data available. No relationship was found between concomitant thiopurine and the prevalence of EPL in 19 studies adding thiopurine to anti-TNF 25,37,38,41,[43][44][45][46]48,52,54,[56][57][58][59][60][68][69][70] (slope, -0.045; 95% CI, -0.258 to 0.168). No relationship between EPL and the percentage of participants with disease activity at conception were found, including 20 studies with sufficient data on disease activity 25,38-41, 43,48,53-59,62,64,65,68,69,75 (slope, -0.033; 95% CI, -0.319 to 0.254).…”

Section: Early Pregnancy Lossmentioning

confidence: 98%

“…No impact of adding thiopurine to anti-TNF was found for stillbirth in 13 studies with sufficient data 23,41,43,44,46,52,58-60,68-70,74,84 (slope, -0.001; 95% CI, -0.008 to 0.005). No relationship between the risk of stillbirth and disease activity at conception was observed in 12 studies with sufficient data on disease activity 23,38,39,41,43,58,59,64,65,68,69,74 (slope, 0.000; 95% CI, -0.013 to 0.012). The overall pooled prevalence of stillbirth was 0% (95% CI, 0%-0%; I 2 ¼ 0%) with biologics use in pregnancy, comparable with a 1% prevalence observed in a cohort of 1960 women with IBD 81 and the 2% prevalence in the general population for stillbirth.…”

Section: Stillbirthmentioning

confidence: 99%

“…The pooled prevalence of EPL was 7% (95% CI, 5%-8%) in 31 studies with administration of TNF inhibitors, 22,25,[37][38][39]41,[43][44][45][46]48,49,[51][52][53][54][55][56][57][58][59][60]65,66,[68][69][70]72,73,75,77 18% (12%-24%) in 4 studies with VDZ, 40,62,64,65 or 17% (12%-22%) in 2 studies with UST 63,67 (Figure 1). Subgroup analyses identified a significantly higher prevalence of EPL in patients exposed to VDZ (P ¼ .001) or UST (P < .001) compared with TNF inhibitors, although these data should be interpreted with caution because of limited data available.…”

Section: Early Pregnancy Lossmentioning

confidence: 99%

“…The pooled prevalence of stillbirth was 0% (0%-0%) in 20 studies with anti-TNF, 23,38,39,41,43,44,46,49,52,[58][59][60]65,66,[68][69][70][72][73][74] 0% (0%-0%) in 3 studies with VDZ, 64,65,79 and 0% (0%-0%) in 2 studies with UST 35,63 (Supplementary Figure 2). Subgroup analyses did not identify any differences in the prevalence of stillbirth between the groups exposed for TNF inhibitors: VDZ (P ¼ .980) or UST (P ¼ .875).…”

Section: Stillbirthmentioning

confidence: 99%

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Biologics for Inflammatory Bowel Disease and Their Safety in Pregnancy: A Systematic Review and Meta-analysis

Nielsen

Gubatan

Juhl

et al. 2022

Clinical Gastroenterology and Hepatology

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BACKGROUND & AIMS:Biologics are used routinely in pregnant women with inflammatory bowel disease (IBD), but large-scale data reporting adverse pregnancy outcomes among biologic users are lacking. We sought to estimate the prevalence of adverse pregnancy outcomes in women with IBD on biologic therapies. METHODS:We searched major databases from inception to June 2020 for studies estimating the prevalence of adverse pregnancy outcomes in IBD when using biologics (anti-tumor necrosis factor [TNF], anti-integrins, and anticytokines). Prevalence and relative risk (RR) were pooled using a random-effects model. RESULTS:Forty-eight studies were included in the meta-analysis comprising 6963 patients. Biologic therapy in IBD pregnancies was associated with a pooled prevalence of 8% (95% CI, 6%-10%; I 2 [ 87.4%) for early pregnancy loss, 9% (95% CI, 7%-11%; I 2 [ 89.9%) for preterm birth, 0% (95% CI, 0%-0%; I 2 [ 0%) for stillbirth, 8% (95% CI, 5%-10%; I 2 [ 87.0%) for low birth weight, and 1% (95% CI, 1%-2%; I 2 [ 78.3%) for congenital malformations. These rates are comparable with those published in the general population. In subgroup analyses of a small number of studies, the prevalence of early pregnancy loss and preterm birth were higher in

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Section: Preterm Birthmentioning

confidence: 97%

Section: Early Pregnancy Lossmentioning

confidence: 98%

Section: Stillbirthmentioning

confidence: 99%

Section: Early Pregnancy Lossmentioning

confidence: 99%

Section: Stillbirthmentioning

confidence: 99%

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Biologics for Inflammatory Bowel Disease and Their Safety in Pregnancy: A Systematic Review and Meta-analysis

Nielsen

Gubatan

Juhl

et al. 2022

Clinical Gastroenterology and Hepatology

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Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review

Ghalandari

Dolhain

Hazes

et al. 2020

Drugs

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Background Inflammatory autoimmune diseases are chronic diseases that often affect women of childbearing age. Therefore, detailed knowledge of the safety profile of medications used for management of inflammatory autoimmune diseases during pregnancy is important. However, in many cases the potential harmful effects of medications (especially biologics) during pregnancy (and lactation) on mother and child have not been fully identified. Objective Our aim was to update the data on the occurrence of miscarriages and (major) congenital malformations when using biologics during pregnancy based on newly published articles. Additionally, we selected several different secondary outcomes that may be of interest for clinicians, especially information on adverse events in the use of a specific biologic during pregnancy. Material and Methods A search was conducted from 1 January 2015 until 4 July 2019 in Embase.com, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar with specific search terms for each database. Selection of publications was based on title/abstract and followed by full text (double blinded, two researchers). An overview was made based on outcomes of interest. References of the included publications were reviewed to include and minimize the missing publications. Results A total of 143 publications were included. The total number of cases ranged from nine for canakinumab to 4276 for infliximab. The rates of miscarriages and major congenital malformations did not show relevant differences from those rates in the general population. Conclusion Despite limitations to our study, no major safety issues were reported and no trend could be identified in the reported malformations.

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P519 Anti-tumour necrosis-alpha therapy during pregnancy in patients with inflammatory bowel disease: safety in women and children

Cited by 2 publications

References 0 publications

Biologics for Inflammatory Bowel Disease and Their Safety in Pregnancy: A Systematic Review and Meta-analysis

Biologics for Inflammatory Bowel Disease and Their Safety in Pregnancy: A Systematic Review and Meta-analysis

Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review

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