Maternal and foetal adverse events with tumour necrosis factor-alpha inhibitors in inflammatory bowel disease

Deepak, Parakkal; Stobaugh, Derrick J.

doi:10.1111/apt.12936

Cited by 35 publications

(21 citation statements)

References 26 publications

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“…108 In an observational study, the use of thiopurines was not associated with increased odds of maternal or fetal adverse events, either as monotherapy (OR, 2.55; 95% CI, 0.95-6.88) or in combination with anti-TNF therapy (OR, 0.97; 95% CI, 0.49-1.93). 109 Data from the large Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) registry reported that the use of combination therapy was not associated with an increase in adverse pregnancy outcomes or cesarean delivery. 110 Observational studies suggest no relationship between maternal use of combination therapy and the rate of infection among offspring compared with anti-TNF therapy alone.…”

Section: Medical Management Of Ibd During Pregnancymentioning

confidence: 99%

The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy

et al. 2016

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Section: Medical Management Of Ibd During Pregnancymentioning

confidence: 99%

The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy

et al. 2016

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“…Due to steroid refractory flare, IFX mono-therapy was begun at the 17th gestational week (in patient anti-tumor necrosis factor α (TNFα) antagonist and AZA naïve) according to the recent recommendations [2,10] . The observational study by Deepak and Stobaugh [16] found that combination therapy with anti-TNFα and thiopurines was not associated with increased odds of maternal or fetal AEs (OR 0.97, 95% CI 0.49-1.93). Data from Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) registry [17] confirmed no association of combination therapy with a higher risk for spontaneous abortion, low birth weight, or congenital abnormalities and cesarean delivery.…”

Section: Discussionmentioning

confidence: 97%

Case Report: Acute Flair of Ulcerative Colitis during Pregnancy Is Still a Major Problem

Protić

Marković²,

Tarabar³

2017

Dig Dis

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Although severe flare of ulcerative colitis (UC) is uncommon, it significantly increases the risk of preterm delivery, low birth weight and other adverse fetal outcomes. It is critical to optimize aggressive medical treatment with both mother and fetal health. Here, we present a case of a 30-year-old woman with a severe flare of UC at the 16th gestational week. The diagnosis of extensive UC was established 8 years ago. From the time she was diagnosed, she had 5 moderate flares successfully treated with oral and topical mesalamine. The relapses of disease occurred due to poor adherence to maintenance therapy. The patient had a positive family history for UC and thrombophilia (factor V Leiden mutations). At the time of admission, she presented with 8-10 bloody diarrheas and moderate abdominal pain. She was afebrile with increased heart rate (96/min). Laboratory studies showed elevated C-reactive protein (CRP, 42 mg/l), fecal-calprotectin (7,223 μg/g), and anemia (hemoglobin 10.4 g/dl). Clostridium difficile and CMV infection were excluded. Intensive treatment with systemic steroids and low-molecular weight heparin was started. Three days later, no response to the therapy was observed (8 bloody stools, CRP 40 mg/l). According to emergency symptoms, rescue therapy with infliximab (IFX; 5 mg/kg standard induction protocol) was administered a week later. A partial clinical and laboratory response was achieved after the second dose of IFX (4 stools/day, CRP 12.2 mg/l and FCP 1,078 μg/g). The patient received the third and least doses of IFX at the 23rd gestational week. She continued on corticosteroids and mesalamine with chronically active moderate disease. IFX trough levels before the third dose were 20.6 μg/ml; antibodies to IFX were negative. The patient delivered trans-vaginally a healthy girl on the 36th gestational week (the newborn weight: 3,150 kg, APGAR score 9). No live vaccines were administrated to the newborn until 6 months of age.

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“…Many studies and publications on pregnancies under IFX treatment have shown no indications of elevated malformation risks [25, 51–53]. …”

Section: Biologics: Tnf-α Inhibitorsmentioning

confidence: 99%

“…Over an observation period of 3.8 years, a prospective study in 30 children whose mothers had taken thiopurines during pregnancy and/or breastfeeding found no evidence of physical or psychosocial developmental disorders, immunodeficiencies or increased risks of infection compared to a normative control group [ 24 ]. The US Food and Drug Administration (FDA) adverse event reporting system has currently also received no reports indicating that thiopurines alone or in combination with TNF-α blockers are associated with an increased risk for mothers and their infants [ 25 ]. Finally, having published the outcomes of 797 pregnancies in abstracts only, the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) registry found no elevated risks of spontaneous miscarriages, CM, preterm deliveries, intrauterine growth disorders, abnormal development or cesarean sections under thiopurines [ 26 ]; however, a higher infection rate was described in babies aged 9–12 months in the combination group (thiopurines and TNF-α blockers) compared to non-exposed children.…”

Section: Immunosuppressives and Disease-modifying Antirheumatic Drugsmentioning

confidence: 99%

“…The FDA has classified the antibody biologic drugs infliximab (IFX), adalimumab (ADA) and golimumab (GOL) as category B, meaning that there is no evidence so far of aggravated risks of malformation in pregnant women under these treatments. Many studies and publications on pregnancies under IFX treatment have shown no indications of elevated malformation risks [ 25 , 51 – 53 ].…”

Section: Biologics: Tnf-α Inhibitorsmentioning

confidence: 99%

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Immunosuppressives and biologics during pregnancy and lactation

Puchner

Gröchenig

Sautner

et al. 2019

Wien Klin Wochenschr

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SummaryAn increasing and early-onset use of immunosuppressives and biologics has become more frequently seen among patients with inflammatory bowel diseases (IBD) and rheumatic disorders. Many women in their childbearing years currently receive such medications, and some of them in an interdisciplinary setting. Many questions arise in women already pregnant or wishing to conceive with respect to continuing or discontinuing treatment, the risks borne by the newborns and their mothers and long-term safety. Together with the Austrian Society of Rheumatology and Rehabilitation, the IBD working group of the Austrian Society of Gastroenterology and Hepatology has elaborated consensus statements on the use of immunosuppressives and biologics in pregnancy and lactation. This is the first Austrian interdisciplinary consensus on this topic. It is intended to serve as a basis and support for providing advice to our patients and their treating physicians.

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Maternal and foetal adverse events with tumour necrosis factor-alpha inhibitors in inflammatory bowel disease

Abstract: SUMMARY BackgroundTransplacental transfer of tumour necrosis factor-alpha (TNF-a) inhibitors has been shown in mothers receiving therapy for inflammatory bowel disease (IBD).

Cited by 35 publications

References 26 publications

The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy

The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy

Case Report: Acute Flair of Ulcerative Colitis during Pregnancy Is Still a Major Problem

Immunosuppressives and biologics during pregnancy and lactation

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