Continuation of Stelara during pregnancy ‘of low risk’ to women with IBD, offspring
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Key takeaways:
- Infants exposed to induction therapy were not at a “substantially increased risk” for adverse pregnancy outcomes.
- Nearly 75% of infants had undetectable ustekinumab concentrations by 6 months.
Treatment with Stelara for inflammatory bowel disease did not increase the risk for adverse maternal or fetal pregnancy outcomes, and infants exposed in utero reached developmental milestones in the first year of life, data showed.
“Activity in IBD during pregnancy increases the risk of adverse pregnancy outcomes,” Mette Julsgaard, MD, PhD, of the department of hepatology and gastroenterology at Aarhus University Hospital, and colleagues wrote in Clinical Gastroenterology and Hepatology. “International guidelines recommend that pregnant women with active disease should be managed as nonpregnant patients with respect to the use of biologics, including the use of ustekinumab.”
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They continued: “There is a paucity of data on how intrauterine exposure to ustekinumab affects offspring development and infection risks.”
In a prospective study, Julsgaard and colleagues recruited 76 pregnant women from 19 hospitals in Denmark and the Netherlands who were treated with Stelara (ustekinumab, Janssen) for IBD from 2018 to 2022. Studied outcomes included ustekinumab concentrations in umbilical cord blood as well as infant infections leading to hospitalization or treatment with antibiotics and developmental milestones.
According to results, 58% of women experienced disease activity during pregnancy, while 42% were in remission; those with ulcerative colitis had a higher risk for disease activity compared with those with Crohn’s disease (RR = 1.65; 95% CI, 1.17-2.32) and were more likely to receive induction therapy during pregnancy (RR = 3.92; 95% CI, 1.59-9.69).
Of 78 live-born infants, 8% were born with congenital malformations and 9% were born moderately preterm. Compared with maintenance exposure, infants exposed to induction therapy were not at a “substantially increased risk” for adverse pregnancy outcomes, including preterm birth, low birth weight, small for gestational age and/or congenital malformations (RR = 2.1; 95% CI, 0.84-5.24).
Median cord and maternal ustekinumab concentrations at birth were 3 µg/mL and 1.4 µg/mL, respectively, with a median infant-to-mother concentration ratio of 2.18 (95% CI, 1.69-2.81). Although all infants had detectable ustekinumab in umbilical cord blood at birth, by 6 months 74% had undetectable concentrations, with “extremely low” median concentrations (0.015 µg/mL) detected in the remaining 26%.
Researchers reported no variation in median ustekinumab concentration between infants born with (2.8 µg/mL) or without (3.1 µg/mL) infections in the first year of life.
“No adverse maternal or fetal pregnancy outcomes were observed during ustekinumab therapy and infants exposed in utero to ustekinumab demonstrated normal developmental milestones at 12 months of age,” Julsgaard and colleagues concluded. “The risk of infant infection was not associated with ustekinumab concentration at birth.”
They added, “Continuation of ustekinumab throughout pregnancy is of low risk for pregnant women and their offspring.
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