Journal of Crohn's & colitis · 2026
Limited placental transfer and clearance of risankizumab by 6 months following in utero exposure.
СтатьяКлинический случайНазвание и аннотация: Перевод в очереди
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Balmer Christina, Korgaard Julie, Holmboe Charlotte Henneberg, Neldeborg Signe, Julsgaard Mette
Аннотация
BACKGROUND AND AIMS: The recent Global Consensus supports the use of risankizumab during pregnancy. However, infant clearance following in utero exposure remains unknown, and data on placental transfer are scarce. We report on infant clearance following in utero exposure to risankizumab, and characterize placental transfer and infant outcomes.
METHODS: Two pregnant women with inflammatory bowel disease exposed to risankizumab during pregnancy were included. Maternal serum and umbilical cord blood were collected at delivery, and infant serum at 3 and 6 months postpartum. Infant development was assessed using the Ages and Stages Questionnaire®, and infections and vaccine tolerance were assessed by maternal questionnaire, telephone follow-up, and review of infant medical records.
RESULTS: One woman with ulcerative colitis initiated risankizumab during pregnancy following disease flare, whereas one woman with Crohn's disease continued intravenous maintenance therapy. Maternal concentrations exceeded cord blood concentrations in both pairs, with a median cord blood-to-maternal ratio of 0.19 (range, 0.14-0.23). At 3 months, the median infant concentration was 0.42 μg/mL (range, 0.37-0.47). At 6 months, the concentration was below the lower limit of quantification in one infant (sampling failed in the other). No adverse pregnancy or infant outcomes were observed.
CONCLUSIONS: Risankizumab showed limited placental transfer, with cord blood concentrations substantially lower than maternal concentrations and clearance within the first 6 months of life. These early findings support the Global Consensus recommendations that risankizumab may be continued during pregnancy and that live BCG vaccine may be administered from 6 months of age, although larger prospective studies are needed.
METHODS: Two pregnant women with inflammatory bowel disease exposed to risankizumab during pregnancy were included. Maternal serum and umbilical cord blood were collected at delivery, and infant serum at 3 and 6 months postpartum. Infant development was assessed using the Ages and Stages Questionnaire®, and infections and vaccine tolerance were assessed by maternal questionnaire, telephone follow-up, and review of infant medical records.
RESULTS: One woman with ulcerative colitis initiated risankizumab during pregnancy following disease flare, whereas one woman with Crohn's disease continued intravenous maintenance therapy. Maternal concentrations exceeded cord blood concentrations in both pairs, with a median cord blood-to-maternal ratio of 0.19 (range, 0.14-0.23). At 3 months, the median infant concentration was 0.42 μg/mL (range, 0.37-0.47). At 6 months, the concentration was below the lower limit of quantification in one infant (sampling failed in the other). No adverse pregnancy or infant outcomes were observed.
CONCLUSIONS: Risankizumab showed limited placental transfer, with cord blood concentrations substantially lower than maternal concentrations and clearance within the first 6 months of life. These early findings support the Global Consensus recommendations that risankizumab may be continued during pregnancy and that live BCG vaccine may be administered from 6 months of age, although larger prospective studies are needed.