Is safety infliximab during pregnancy in patients with inflammatory bowel disease?

Argüelles-Arias, Federico; Castro-Laria, Luisa; Acosta, Manuel Barreiro‐de; García-Sánchez, M.V.; Guerrero-Jiménez, Pedro; Gómez-García, M; Cordero-Ruíz, Patricia; Iglesias-Flores, Eva; Gómez-Camacho, Federico; Domínguez-Muñoz, E.; Herrerías‐Gutiérrez, Juan Manuel

doi:10.4321/s1130-01082012000200003

Cited by 24 publications

(18 citation statements)

References 21 publications

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“…In this systematic review, identifying 17 case reports related to IFX [14,16,20,22,23,29,30,33],[34,40,41,45,47,63-66], 13 case series [12,17,19,28,32,37-39,42,43],[46,67,68], 2 uncontrolled cohort studies [19,36, and 2 controlled cohort studies [48,69] (Table 2), we found the prevalence of pregnancy complications, including preterm delivery, stillbirth, low birth weight, miscarriages, or congenital malformations in children exposed to IFX throughout pregnancy is limited, even after exposure to biologics throughout the third trimester. However, the use of IFX up to week 30 of gestation results in fetal intra-uterine exposure to high IFX levels (up to three-fold higher than in the maternal peripheral blood), which may raise concerns about the long-term effects of IFX on these children, including effects on their immune system [50].…”

Section: Resultsmentioning

confidence: 99%

Safety of TNF-α inhibitors during IBD pregnancy: a systematic review

Nielsen

Loftus

Jess

2013

BMC Med

117

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BackgroundTumor necrosis factor (TNF)-α inhibitors are increasingly being used in inflammatory bowel disease (IBD). Because this chronic intestinal disorder often affects women of fertile age, it is essential to assess the effect of biologics on pregnancy outcome.MethodsWe performed a systematic review of the English-language literature to investigate if treatment with TNF-α blockers during pregnancy in women with IBD increases the risk of spontaneous abortions, preterm delivery, stillbirth, low birth weight, congenital malformations, or risk of infections in the offspring. Of 552 articles and abstracts reviewed, 58 articles or abstracts with unique content were identified and included in this systematic review. However, most presentations were case reports or case series supplied by a limited number of observational studies. No randomized controlled studies were available.ResultsTNF-α inhibitors do not seem to affect either outcome of pregnancy in mothers with IBD, or the outcome in the offspring (congenital malformations and immunosuppression). Further, recent data have not identified any increased risk of infections in the first year of life in the offspring of mothers who received biologics, even in combination with immunomodulators (thiopurines).ConclusionsFrom the present systematic review, no association was found between administration of TNF inhibitors for IBD during pregnancy and adverse pregnancy outcome or congenital abnormalities. Further, no increased relative risk of infections has been reported in the first year of life in offspring of mothers who received biologics. Biologics should be discontinued during pregnancy solely if the IBD is in remission using the same stopping criteria as for patients with IBD in general, as uncontrolled activity of IBD may expose the mother and child to a risk greater than those only potentially coming from the use of TNF-α inhibitors. In such cases, inoculation of the offspring with live vaccines is contraindicated until the biologic agent is no longer detectable in the child’s circulation.

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Section: Resultsmentioning

confidence: 99%

Safety of TNF-α inhibitors during IBD pregnancy: a systematic review

Nielsen

Loftus

Jess

2013

BMC Med

117

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“…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%

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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“…[23][24][25][26][27][28]34,35,39,41,[43][44][45][46][47][48][49][50][51] Overall, the proportion of CAs reported in published studies was 2.72% (95% CI 1.68-3.74). The population registries identified were pooled using a random-effects meta-analysis and demonstrated a proportion of CAs of 2.35% (95% CI 1.80-2.98).…”

Section: Comparison With Population Datamentioning

confidence: 99%

“…However, 19 eligible studies were included in the calculation of total CA prevalence from all published studies (Table 2). [23][24][25][26][27][28]34,35,39,41,[43][44][45][46][47][48][49][50][51] Also excluded were case reports or small case series (n < 10), or manuscripts where there was incomplete information on birth outcomes such that ORs could not be calculated. [79][80][81][82][83][84][85][86] Of the studies with repeat population groups, 27,29,30,36,45,46,49,51,79,80,82,[84][85][86][87][88][89][90][91] the most recent study was selected for inclusion provided data could be extracted.…”

Section: Studies Retrievedmentioning

confidence: 99%

Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis

Shihab

Yeomans

Cruz

2016

ECCOJC

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Background and Aims: Inflammatory bowel disease (IBD) commonly affects women during their reproductive years, leading to concerns regarding pregnancy outcomes and therapeutic safety. The aim of this study was to assess the risks associated with anti-tumour necrosis factor α (anti-TNFα) therapy for pregnancy outcomes, including rates of congenital abnormality, based on published studies. Methods: Published studies were screened from on-line databases and international meeting abstracts. A meta-analysis was performed for adverse pregnancy outcomes (APOs), congenital abnormalities (CAs), preterm birth (PTB) and low birth weight (LBW). The prevalence of CAs was compared with whole-population pooled registry data. Results: In women exposed to anti-TNFα the pooled odds ratio for APOs was 1.14 (95% confidence interval [CI] 0.73-1.78; p = 0.55) compared with disease-matched controls. The pooled odds ratios for CAs, PTB and LBW were 0.89 (0.37-2.13; p = 0.79), 1.21 (0.74-2.00; p = 0.45) and 1.36 (0.77-2.38; p = 0.29) respectively. The rate of CAs in TNFα-exposed women was not statistically different from that in population-wide registries (difference 0.4%, 95% CI −2.0 to +2.7). Conclusions: Anti-TNFα therapy does not increase the risk of APOs, CAs, PTB or LBW compared with disease-matched controls. Furthermore, the risk of CAs is not increased when published prevalence data are compared with data for the general population. These findings may offer some reassurance for women and physicians regarding the safety profile of anti-TNFα during pregnancy in IBD.

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Is safety infliximab during pregnancy in patients with inflammatory bowel disease?

Cited by 24 publications

References 21 publications

Safety of TNF-α inhibitors during IBD pregnancy: a systematic review

Safety of TNF-α inhibitors during IBD pregnancy: a systematic review

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

Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis

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