85which were healthy without any congenital defects or adverse events compared to
90.7% (68/75) live births and 85.3% (58/68) of which were healthy with no con-
genital defects or adverse events in the IBD patients on other therapies [ 32 ]. An
early retrospective chart review including ten women exposed to IFX during preg-
nancy reported live births of normal infants in all cases, three were born premature
(<37 weeks gestation) and one had a low birth weight (<2500 g) [ 33 ]. In another
case series of four women who continued IFX treatment during pregnancy, all deliv-
ered full-term, healthy infants, with detectable cord blood drug levels in 75% (3/4)
and undetectable drug levels in one infant with the longest duration between last
infusion, at gestational week (GW) 21, and delivery [ 28 ]. None of the children were
noted to have an increased rate of infections, and all developed protective antibody
levels at 6 months of age to the Haemophilus influenzae type B and pneumococcal
vaccines.
Adalimumab
With respect to studies that only included ADA, there are several case reports of
ADA use during preconception, and into the first trimester [ 34 ], several reports of
ADA continued throughout pregnancy due to ongoing active IBD [ 35 , 36 ] and a
report of the use of ADA during pregnancy for worsening, steroid-refractory disease
[ 37 ]. In each of these case reports, regardless of when treatment with ADA was
initiated or how long into the pregnancy it was continued, all pregnancies resulted
in the birth of a healthy infant without any developmental abnormalities at 6 months
[ 35 , 36 ], at 1 year [ 37 ], and at up to 2 years of observation [ 34 ]. In a prospective
cohort study by the Organization of Teratology Information Specialists (OTIS), data
presented in abstract form showed no increase in adverse fetal outcomes among
women with RA treated with ADA compared to a cohort of women with RA not
treated with ADA and compared to a cohort of healthy controls [ 38 ]. A recent analy-
sis of adverse events data from the Adalimumab Pregnancy Exposure Registry
(APER), which is a prospective observational cohort study conducted by OTIS,
includes 15,132 patients with RA exposed to ADA and found no increase in the risk
of SA or major birth defects in the ADA-exposed RA cohort compared to the unex-
posed RA cohort and the healthy controls [ 39 ].
Certolizumab Pegol
An initial case report of the use of CZP during pregnancy included a 22-year-old
woman who received 11 injections preconception, 1 injection during the first tri-
mester, and 1 injection in the third trimester due to active Crohn’s disease [ 40 ].
The patient delivered a normal healthy infant with normal development as of
1 month of age. More recently, outcomes from 339 pregnancies (192 in women
6 Biologics in Pregnancy and Breastfeeding