Abstract | Background: Methods: Results: Of 1157 patients enrolled in the UC interventional studies, 301 were women of childbearing age. Eleven cases of maternal exposure and 14 cases of paternal exposure to tofacitinib (doses of 5 mg or 10 mg twice daily) before/at the time of conception or during pregnancy were identified. Outcomes included 15 healthy newborns, no fetal deaths, no neonatal deaths, no congenital malformations, 2 spontaneous abortions, and 2 medical terminations. Outcomes across other tofacitinib studies and postmarketing cases were consistent, with a healthy newborn being the most common outcome and no fetal deaths. Conclusions: Based on the limited data available, pregnancy and newborn outcomes among patients with prenatal (maternal/paternal) exposure to tofacitinib in UC studies appear similar to those reported for other tofacitinib clinical study populations and the general population.
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Authors | Uma Mahadevan, Marla C Dubinsky, Chinyu Su, Nervin Lawendy, Thomas V Jones, Amy Marren, Haiying Zhang, Daniela Graham, Megan E B Clowse, Steven R Feldman, Daniel C Baumgart |
Journal | Inflammatory bowel diseases
(Inflamm Bowel Dis)
Vol. 24
Issue 12
Pg. 2494-2500
(11 29 2018)
ISSN: 1536-4844 [Electronic] England |
PMID | 29982686
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Janus Kinase Inhibitors
- Piperidines
- Pyrimidines
- Pyrroles
- tofacitinib
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Topics |
- Adult
- Colitis, Ulcerative
(drug therapy)
- Databases, Factual
- Female
- Humans
- Infant, Newborn
- Janus Kinase Inhibitors
(administration & dosage)
- Male
- Maternal Exposure
- Paternal Exposure
- Piperidines
(administration & dosage)
- Pregnancy
- Pregnancy Outcome
- Pyrimidines
(administration & dosage)
- Pyrroles
(administration & dosage)
- Randomized Controlled Trials as Topic
- Young Adult
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