Paternal exposure to most IBD medications not linked to adverse neonatal outcomes
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SAN DIEGO — Paternal exposure to the majority of therapies for inflammatory bowel disease did not increase the risk for adverse neonatal outcomes, according to data from a small patient subset presented at Digestive Disease Week 2022.
“Over the past couple of decades, our ability to care for pregnant women with IBD has improved considerably; we have a good understanding of risk factors and we have learned a lot about the safety of medications that we use for our pregnant mothers,” Grant E. Barber, MD, resident physician at Stanford University Hospital, told attendees. “An area that hasn't been explored nearly as thoroughly is the importance of health and IBD medications that we use in our fathers who wish to conceive.”
In a retrospective cohort study of U.S. insurance claims from 2009 to 2016, Barber and colleagues identified 13,535 pregnancies where a paternal immune-mediated diagnosis required IBD medication; medications included thiopurines, methotrexate, tumor necrosis factor-alpha antagonists, ustekinumab (Stelara, Janssen), prednisone, budesonide, mesalamine and sulfasalazine. The researchers defined exposure as the presence of an insurance claim for the respective medication within 90 days of conception. Studied outcomes included neonatal outcomes as well as maternal outcomes.
Compared with fathers unexposed to IBD medication, TNF-alpha antagonists had no increased risk for adverse neonatal or pregnancy outcome including no live birth (OR = 0.92; 95% CI, 0.8-1.05) and preterm birth (OR = 0.97; 95% CI, 0.75-1.25). Similarly, neither thiopurine monotherapy or thiopurine combination therapy (OR = 0.9; 95% CI, 0.74-1.09) was associated with no live birth.
However, paternal exposure to methotrexate was linked to an increased risk for no live birth (OR = 2.58; 95% CI, 1.2105.5) and exposure to ustekinumab was linked to an increased risk for preterm birth (OR = 2.49; 95% CI, 1.26-4.89), low birth weight (OR = 2.86; 95% CI, 1.33-6.12) and newborn ICU stay (OR = 3.67; 95% CI, 1.09-12.4).
Therapeutic exposure did not correlate with birth defects.
“The majority of paternal medications used in IBD had no association with adverse neonatal/reproductive outcomes,” Barber said. “Paternal methotrexate exposure was
associated with increased stillbirths and ustekinumab associated with preterm birth, low birth weight and need for NICU stay. While this is the first study to suggest risks, the total numbers are too low to draw meaningful conclusions or change practice.”
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Barber GE, et al. Abstract 452. Presented at: Digestive Disease Week; May 21-24, 2022; San Diego (hybrid meeting).
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