Exposure during pregnancy to Il-1 targeted therapies and pregnancy, fetal and neonatal outcomes: a study from the French Teratology Information Service.

Objective: To describe the outcomes of pregnancies exposed to IL-1 targeted therapies (anti-IL-1): anakinra and/or canakinumab.

Methods: We performed a descriptive observational study based on data from CRAT, the French Teratology Information Service. We included prospective and retrospective pregnancies exposed to anakinra and/or canakinumab with known outcomes.

[The new version of the French teratology information service "CRAT" website].

The Centre de Référence sur les Agents Tératogènes (CRAT) is a unique French national reference center involved in the risk assessment of exogenous agents (mainly drugs, but also medical imaging and addictions) on pregnancy, breastfeeding and fertility. To help improve patient care, CRAT makes its expertise available to healthcare professionals via its website (www.lecrat.

[Use of anti-IL-1 drugs during pregnancy].

Anti-Interleukin-1 (Anti-IL-1) drugs are used to treat some chronic rheumatic diseases that can affect young people, including women of childbearing age. Two anti-IL-1 drugs are available in France: anakinra and canakinumab. Data on their use during pregnancy are still limited.

[Evaluation of the satisfaction of healthcare professionals using the CRAT website, and launch of a new version].

In preparation for a new version of the CRAT (Centre de référence sur les agents tératogènes) website, an evaluation of user satisfaction was carried out. An invitation to complete an online questionnaire covering the various dimensions of the website (appearance, content, interactivity, ease of use, technical performance) was sent in April 2022 to healthcare professionals who referred to CRAT for clinical expertise over the previous two years. After sending out 3224 individual e-mail invitations, 758 evaluators completed the questionnaire in full (response rate: 23.

[Varicella vaccination, pregnancy and breastfeeding: The current situation].

The varicella vaccine is recommended for women with no history of varicella who are planning to become pregnant, as well as for post-pregnancy women, to prevent the occurrence of this illness and its severe complications, especially an embryopathy, when it occurs in a pregnant woman (congenital varicella syndrome). This live attenuated vaccine should not be administered during pregnancy, nor in the month preceding it. However, when this occurs inadvertently, the data collected on the outcomes of exposed pregnancies, although few in women seronegative at the time of vaccination, allow to reassure the patients to date, as no congenital varicella syndrome has been reported to date following accidental vaccination in early pregnancy.

Effects of maternal modafinil treatment on fetal development and neonatal growth parameters - a multicenter case series of the European Network of Teratology Information Services (ENTIS).

Objective: In recent years, safety concerns about modafinil exposure during pregnancy have emerged. In particular, increased risks for major congenital anomalies (MCA) and impaired fetal growth were reported, although study results were conflicting. Our investigation aims to examine previously reported safety signals.

Pregnancy outcome after first trimester exposure to ionizing radiations.

Objective: To evaluate the effects of ionizing radiation exposure during the first trimester of pregnancy in usual clinical situations.

Study Design: We conducted a prospective observational cohort study using data collected between 1987 and 2014. This database was authorized by the French "Commission Nationale de l'Informatique et des Libertés".

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

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.

Exposure to aripiprazole during embryogenesis: a prospective multicenter cohort study.

Purpose: The main purpose of this study was to evaluate the risk of major malformations after aripiprazole exposure during the embryonic period. The secondary purposes were to assess the risk of miscarriage, prematurity, fetal growth retardation and maternal complications and to describe possible neonatal adverse effects.

Methods: We conducted a cohort study using data prospectively collected by the French Pharmacovigilance Centres participating to the Terappel program and the Centre de Référence sur les Agents Tératogènes between 2004 and 2011.

Pregnancy outcome after methotrexate treatment for rheumatic disease prior to or during early pregnancy: a prospective multicenter cohort study.

Objective: High-dose methotrexate (MTX) exposure during pregnancy is associated with embryopathy. The teratogenic potential of MTX at dosages typically used in the treatment of rheumatic diseases remains uncertain. The aim of this study was to evaluate the risk of spontaneous abortion, major birth defects, elective termination of pregnancy, shortened gestational age at delivery, and reduced birth weight in women exposed to MTX.

Birth defects after exposure to misoprostol in the first trimester of pregnancy: prospective follow-up study.

Misoprostol during the first trimester of pregnancy is associated with a specific malformative pattern (Moebius sequence and limb defects) whose incidence remains unknown. Data originate mostly from illegal use for abortion and are mainly retrospective. The present prospective controlled study analyses outcomes of first trimester misoprostol exposures after medical prescriptions.

Paternal exposure to methotrexate and pregnancy outcomes.

Objective: To assess the risk of major malformation in the case of paternal exposure to methotrexate (MTX) at the time of conception.

Methods: Using prospective data of our Teratology Information Service, we analyzed outcomes of paternal MTX exposure at the time of conception or up to 3 months before conception.

Results: We report on the outcomes of 42 pregnancies involving 40 men treated with MTX at the time of conception.

Rheumatology drugs and pregnancy.

Medication exposure during pregnancy, especially in the first trimester, is a common event that causes considerable concern among patients and healthcare professionals alike. Once the pregnancy is known, the response often consists in stopping or substantially diminishing the use of medications. Some medications are teratogenic and/or fetotoxic, requiring effective birth control and prior information of women of childbearing potential.

Modulation of endocrine and transport functions in human trophoblasts by saquinavir and nelfinavir.

Objectives: The distribution of drugs to the maternal-fetal interface is influenced by the expression of various efflux transporters. Among these transporters, P-glycoprotein (P-gp) is responsible for the efflux of a great number of drugs such as protease inhibitors of the human immunodeficiency virus, thus reducing the chemical exposure of the fetus.

Study Design: The effects of saquinavir and nelfinavir were evaluated on human trophoblast functions and integrity by investigating their effect on human chorionic gonadotropin (hCG) secretion and on P-gp expression and functionality.

[Placental transfer of drugs].

As the sole interface between the mother and fetus, the placenta is essential for normal fetal development, ensuring the transfer of nutrients and metabolic waste products. The authors examine the barrier function of the placenta, together with the diferent mechanisms of drug transport and the experimental models used to investigate them.

Contribution and limit of the model of perfused cotyledon to the study of placental transfer of drugs. Example of a protease inhibitor of HIV: nelfinavir.

Objectives: The perfused cotyledon model is a very useful method to study placental transfer of drugs. Here we studied placental transfer of the human immunodeficiency virus protease inhibitor nelfinavir using the non-recirculating dual human placental perfusion with a main goal to determining the clearance index of nelfinavir as related to maternal concentrations, and analyze the conditions under which ex vivo and in vivo data can be correlated.

Study Design: Thirteen human cotyledons, obtained after uneventful term pregnancies, were perfused in an open double circuit with nelfinavir (320-4436 microg/l) and a freely diffusing marker antipyrine 20 mg/l, in the presence of an albumin concentration of 2 g/l.