Research conducted by Dana Ďuricová, MD, Ph.D and Katarína Mitrová, MD, Ph.D., has been published in the Clinical Gastroenterology and Hepatology (CGH).
Six women, who suffer from ulcerative colitis were studied to identify and understand the effect of tofacitinib on pregnancy and breastfeeding. The results of this research support the recommendation to avoid breastfeeding due to the unknown risks of infant exposure.
This is an important and influential research, and teams at Iscare and FutureLife are proud of the commitment shown to the research and its contribution to the study of gastroenterology.
CGH is an official clinical journal of the American Gastroenterological Association (AGA) Institute, circulated to more than 20,000 individuals and clinics worldwide, and is ranked as one of the top 10 gastroenterological journals in the world.
Existing evidence regarding the safety of tofacitinib during pregnancy is scarce.
In this case series of six women with ulcerative colitis exposed to tofacitinib during conception and pregnancy, no negative pregnancy or infant outcomes were observed. Tofacitinib demonstrated, for the first time, effective placental transfer with a cord plasma concentration of 74% of the maternal plasma concentration at the time of delivery. The present case is also the first to report tofacitinib breast milk concentrations in a lactating woman on tofacitinib 5 mg twice daily, as the only other report so far was on 10 mg twice daily. Tofacitinib was detected in all 18 milk samples collected at days 20-22 postpartum with the peak concentration 3.5h after tofacitinib intake. The maximum relative exposure of a fully breastfed infant was calculated as 3.4% of the weight-adjusted maternal dose. These findings support the recommendation of avoiding breastfeeding due to the unknown risks of infant exposure.