Biologics and pregnancy: a clinician’s guide to the management of IBD in pregnant women

ABSTRACT

Introduction: Women with inflammatory bowel disease (IBD) endorse a tremendous amount of concern about medication exposure during pregnancy and their effects on the fetus. Medical providers caring for this patient population should be well informed and feel comfortable counseling their patients for the best pregnancy outcome possible.

Areas covered: It is of particular importance to understand the implications of use of biologics in preconception, pregnancy, and postpartum timeframes. Herein, we aim to inform the clinician about the impact of uncontrolled inflammation during pregnancy, the mechanisms of biologic transport through the placenta, the effects of biologics in maternal and neonatal outcomes, and additional postpartum considerations such as breastfeeding and vaccination safety.

Expert opinion: The groundwork already set by previous research in terms of safety of biologic therapy during pregnancy has been reassuring. With the advent of more mechanisms of action but similar protein structure, i.e. they are IgG1 antibodies; the authors anticipate the recommendation of continuation of therapy throughout pregnancy will be sustained.

KEYWORDS:

• Inflammatory bowel disease
• pregnancy
• biologics
• anti-TNF
• outcomes

Article highlights

• Active inflammation prior to conception and during pregnancy has been associated with unfavorable maternal and neonatal outcomes.

• Biologics do not cross the placenta during the first trimester, a crucial time for organogenesis; therefore, they are FDA category B for pregnancy and compatible with lactation per recommendations from the Drugs and Lactation Database (LactMed).

• There is substantial evidence of active intestinal inflammation outweighing the risk of use of biologics during pregnancy; therefore, current North American guidelines recommend continuation of biologics throughout pregnancy.

• A baseline drug level should be obtained prior to conception and adjust the dose as needed. During pregnancy, there is no need for drug level monitoring or dose adjustment.

• There have been isolated case reports of neonatal infections after in-utero exposure to biologics; however, several meta-analyses have demonstrated no difference in risk of infections between exposed versus non-exposed newborns.

• Newborns exposed to biologics in-utero should avoid live vaccines until complete clearance of the biologic has been confirmed in the newborn’s serum.

Declaration of interest

S Kane is a consultant for Pfizer and TechLab. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.