Treatment of Inflammatory Bowel Disease with Biologics

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for low birth weight, preterm birth, and stillbirth [ 8 – 13 ]. Preconception counseling
about the importance of obtaining disease remission at least 3  months prior to
conception as well as the importance of adherence to the appropriate medical treat-
ment in order to maintain remission during pregnancy is paramount to optimizing
pregnancy and neonatal outcomes (Table 6.1). This chapter will provide the most
recent evidence regarding the safety of the currently available biologic medications,
including anti-TNFα inhibitors, anti-integrin medications, and anti-IL-12/IL-23
agents, during pregnancy and with breastfeeding. The US Food and Drug
Administration has implemented a revision to the medication labeling used to indi-
cate safety in pregnancy and breastfeeding and is no longer using letters to indicate
the pregnancy category (i.e., A, B, C, D, X) [ 14 ]. As such, we will not be referencing
these previously used categories in this chapter.

Antitumor Necrosis Factor Agents

Tumor necrosis factor plays a major role in the development and continuation of
inflammation in IBD.  The antitumor necrosis factor α (anti-TNFα) agents are a
group of monoclonal antibodies that inhibit the activity of TNFα, thus blocking the
signaling that leads to inflammation. This group of medications includes infliximab
(Remicade®, Janssen, Malvern PA), which is a chimeric mouse/human immuno-
globulin (Ig) G1 monoclonal antibody approved for use in Crohn’s disease and
ulcerative colitis; adalimumab (Humira®, Abbott, Abbott Park, IL), which is also a
fully human IgG1 monoclonal antibody approved for use in Crohn’s disease and
ulcerative colitis; certolizumab pegol (Cimzia®, UCB, Brussels, Belgium), which is
a polyethylene glycol (PEG)ylated Fab’ fragment of a humanized anti-TNFα mono-
clonal antibody approved in the United States for the treatment of Crohn’s disease;
and golimumab (Simponi®, Janssen, Malvern PA), which is also a fully human

Table 6.1 Outcomes definitions

Term Definition

Adverse pregnancy outcomes Spontaneous abortion/miscarriage

Induced abortion

Preterm birth (delivery <37 weeks of gestation)

Small for gestational age (birth weight <10th percentile for

gestational age)

Stillbirth

Ectopic pregnancy

Adverse fetal/neonatal

outcomes

Congenital anomalies

Low birth weight (<2500 g)

Intrauterine growth restriction

Newborn seizure

Neonatal intensive care unit admission

Infant mortality

J.K.J. Gaidos and S.V. Kane