Treatment of Inflammatory Bowel Disease with Biologics

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Ustekinumab

Animal studies have confirmed the presence of UST in the milk of lactating mon-
keys [ 80 ], which has been generalized to humans with the assumption that it is also
excreted in human breast milk. Similar to anti-TNF agents, the absorption of UST
through the GI tract is assumed to be minimal, with little to no therapeutic effect;
however, that is not definitively known.

Summary and Patient Counseling

Women with IBD have an underlying increased risk for adverse pregnancy out-
comes, which are further increased in the setting of active disease. Disease remis-
sion prior to conception as well as throughout pregnancy is the most important
factor associated with good outcomes. Current available evidence suggests that the
use of anti-TNF medications during pregnancy and with breastfeeding is likely safe;
however, the use of combination anti-TNF and immunomodulatory therapy has
been shown to increase the risk of newborn infections in the first year of life.
Currently, there are limited data on the safety of anti-integrin medications and anti-
IL- 12/IL-23 therapies; however, given the molecular structure, they are likely
actively transported to the fetal circulation during pregnancy. With the active trans-
fer of these biologic medications to the fetus comes the risk of immunosuppression
and the importance of avoiding live vaccines for the first 6 months of life and pos-
sibly up to 1 year or until the serum drug concentrations are no longer detectable in
the child.

References

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2. Boyd HA, Basit S, Harpsoe MC, et al. Inflammatory bowel disease and risk of adverse preg-
   nancy outcomes. PLoS One. 2015;10:e0129567.


3. Mahadevan U, Sandborn WJ, Li DK, et al. Pregnancy outcomes in women with inflammatory
   bowel disease: a large community-based study from Northern California. Gastroenterology.
   2007;133:1106–12.


4. Bröms G, Granath F, Linder M, et al. Complications from inflammatory bowel disease during
   pregnancy and delivery. Clin Gastroenterol Hepatol. 2012;10:1246–52.


5. O’Toole A, Nwanne O, Tomlinson T.  Inflammatory bowel disease increases risk of adverse
   pregnancy outcomes: a meta-analysis. Dig Dis Sci. 2015;60:2750–61.


6. Nielsen OH, Andreasson B, Bondesen S, et  al. Pregnancy in Crohn’s disease. Scand
   J Gastroenterol. 1984;19:724–32.


7. Nielsen OH, Andreasson B, Bondesen S, et  al. Pregnancy in ulcerative colitis. Scand
   J Gastroenterol. 1983;18:735–42.

6 Biologics in Pregnancy and Breastfeeding