Mo1194 Anti-TNFα Therapies Are Safe During Pregnancy in Women With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Narula, Neeraj; Al-Dabbagh, Raed; Dhillon, Amit; Sands, Bruce E.; Marshall, John K.

doi:10.1016/s0016-5085(14)62110-7

Cited by 20 publications

(26 citation statements)

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“…The present study builds on a previous meta-analysis by Narula et al 93 by the inclusion of two recent large studies 46,92 as well as comparison with population-based prevalence data. The inclusion of the most recent studies by Seirafi et al 46 and Diav-Citrin et al 92 contributed 26 and 49% of the weighting for APOs and CAs respectively, highlighting the importance of their contribution to this meta-analysis.…”

Section: Discussionmentioning

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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Section: Discussionmentioning

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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“…Thus, exposure during either planned or unintended pregnancy is considered a likely occurrence. Possible risks discussed after immunosuppressant therapy during pregnancy include teratogenicity, higher rates of spontaneous abortion, preterm birth, growth retardation and compromised fetal immunity [3,4]. Since all the approved TNF-α inhibitors are substances of high molecular weight, they are expected to require active transport to cross the human placenta.…”

Section: Introductionmentioning

confidence: 99%

“…Clinical experience is limited and varies widely between the five agents. In total, approximately 500 pregnancies exposed to TNF-α inhibitors have been published via registries, pharmacovigilance surveillance, case series [3,[5][6][7][8], and cohort studies [9,10]. Additionally a variety of case reports, abstracts and conference communications are available [1,11].…”

Section: Introductionmentioning

confidence: 99%

Pregnancy outcome after TNF‐α inhibitor therapy during the first trimester: a prospective multicentre cohort study

Weber-Schoendorfer

Oppermann

Wacker

et al. 2015

Brit J Clinical Pharma

131

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Aims TNF‐α inhibitors are considered relatively safe in pregnancy but experience is still limited. The aim of this study was to evaluate the risk of major birth defects, spontaneous abortion, preterm birth and reduced birth weight after first trimester exposure to TNF‐α inhibitors. Methods Pregnancy outcomes of women on adalimumab, infliximab, etanercept, certolizumab pegol or golimumab were evaluated in a prospective observational cohort study and compared with outcomes of a non‐exposed random sample. The samples were drawn from pregnancies identified by institutes collaborating in the European Network of Teratology Information Services. Results In total, 495 exposed and 1532 comparison pregnancies were contributed from nine countries. The risk of major birth defects was increased in the exposed (5.0%) compared with the non‐exposed group (1.5%; adjusted odds ratio (ORadj) 2.2, 95% CI 1.0, 4.8). The risk of preterm birth was increased (17.6%; ORadj 1.69, 95% CI 1.1, 2.5), but not the risk of spontaneous abortion (16.2%; adjusted hazard ratio [HRadj] 1.06, 95% CI 0.7, 1.7). Birth weights adjusted for gestational age and sex were significantly lower in the exposed group compared to the non‐exposed cohort (P = 0.02). As a diseased comparison group was not possible to ascertain, the influence of disease and treatment on birth weight and preterm birth could not be differentiated. Conclusions TNF‐α inhibitors may carry a risk of adverse pregnancy outcome of moderate clinical relevance. Considering the impact of insufficiently controlled autoimmune disease on the mother and the unborn child, TNF‐α inhibitors may nevertheless be a treatment option in women with severe disease refractory to established immunomodulatory drugs.

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“…The long-term effects of in utero exposure to anti-TNF are not extensively explored. A recent study shows a normal health outcome and first year development in children exposed to anti-TNF, comparable to children of non-IBD controls [47] . Also preliminary results of 2 ongoing studies showed normal growth and development in anti-TNF exposed children in the first few years of life [48,49] .…”

Section: Anti-tnf Agentsmentioning

confidence: 85%

Proper Use of Inflammatory Bowel Disease Drugs during Pregnancy

Kanis

Woude²

2016

Dig Dis

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Crohn's disease and ulcerative colitis, referred to as inflammatory bowel disease (IBD), are chronic, relapsing conditions. Patients are often diagnosed at a reproductive age, and therefore questions about fertility and reproductions often arise. Preconceptional counseling is the most important aspect in the management of IBD patients with a pregnancy wish. Patients should be counseled on the influence of IBD and IBD drugs on pregnancy. Most drugs are not related to adverse outcome while used during pregnancy. Active disease is related to adverse outcomes; therefore, it is of utmost importance to strive for remission before conception and during pregnancy.

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Mo1194 Anti-TNFα Therapies Are Safe During Pregnancy in Women With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Cited by 20 publications

References 0 publications

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

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

Pregnancy outcome after TNF‐α inhibitor therapy during the first trimester: a prospective multicentre cohort study

Proper Use of Inflammatory Bowel Disease Drugs during Pregnancy

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