Anti-TNF Safety in Pregnant and Breastfeeding Women With IBD
Anti-TNF Safety in Pregnant and Breastfeeding Women With IBD
Anti-TNF drugs seem to be low-risk in pregnancy, at least in the short term. However, they have been shown to cross the placenta from the end of the second trimester, leading to intra-uterine exposure. The preliminary results of the PIANO study demonstrated an increase in the frequency of infection (from 9 to 12 months of age) among infants exposed to a combination of immunomodulators and anti-TNF drugs during pregnancy; these findings highlight the possibility of dysfunctional immune development. Therefore, we believe that it may be recommended to stop this combination during the second trimester (around week 20–22)—if the mother is in remission—in order to avoid intra-uterine exposure. Certolizumab is a Fab fragment of an anti-TNF monoclonal antibody that cannot be transported across the placenta; therefore, it can probably be continued during pregnancy. Vaccination of infants exposed to biological therapy in utero should be given according to standard vaccine schedules, with the exception of live-virus vaccines, which should be provided when there is no detectable anti-TNF in the blood, i.e., in the second half of the first year. Miniscule amounts of anti-TNF drugs are transferred in breast milk; therefore, a deleterious effect of this exposure on the neonate, although unlikely, cannot be excluded.
Conclusions
Anti-TNF drugs seem to be low-risk in pregnancy, at least in the short term. However, they have been shown to cross the placenta from the end of the second trimester, leading to intra-uterine exposure. The preliminary results of the PIANO study demonstrated an increase in the frequency of infection (from 9 to 12 months of age) among infants exposed to a combination of immunomodulators and anti-TNF drugs during pregnancy; these findings highlight the possibility of dysfunctional immune development. Therefore, we believe that it may be recommended to stop this combination during the second trimester (around week 20–22)—if the mother is in remission—in order to avoid intra-uterine exposure. Certolizumab is a Fab fragment of an anti-TNF monoclonal antibody that cannot be transported across the placenta; therefore, it can probably be continued during pregnancy. Vaccination of infants exposed to biological therapy in utero should be given according to standard vaccine schedules, with the exception of live-virus vaccines, which should be provided when there is no detectable anti-TNF in the blood, i.e., in the second half of the first year. Miniscule amounts of anti-TNF drugs are transferred in breast milk; therefore, a deleterious effect of this exposure on the neonate, although unlikely, cannot be excluded.
