86
with Crohn’s disease, 118 in women with rheumatic disease) exposed to CZP
were obtained through review of a large pharmaceutical safety database [ 41 ]. Of
the 339 pregnancies (113 reported retrospectively and 226 reported prospec-
tively), 254 (74.9%) resulted in live births, 52 (15.3%) miscarriages, 32 (9.4%)
induced abortions, and 1 stillbirth. Of the 226 prospectively reported pregnancies,
there were 182 (80.5%) live births, 21 (9.3%) miscarriages, 22 (9.7%) induced
abortions, and 1 stillbirth. Overall, the authors found that there were some differ-
ences in outcomes by report source (i.e., prospective vs. retrospective reporting)
with improved outcomes in the prospectively reported cohort, but overall there
was no increase in the risk of adverse pregnancy or fetal outcomes with the use of
CZP in pregnancy.
Golimumab
Using individual patient cases reported to the manufacturer, one study presented in
abstract form has looked at the outcomes of 47 pregnancies among women with
autoimmune diseases (30 RA, 1 psoriatic arthritis [PsA], 5 ankylosing spondylitis,
11 UC) treated with golimumab [ 42 ]. There were 26 (55.3%) live births, 13 (27.7%)
SAs, 7 (14.9%) induced abortions, and 1 (2.1%) ectopic pregnancy. Methotrexate
was taken concurrently in 12 pregnancies and was used in 4 of the 13 (30.8%) of the
reported SAs and in the 1 case of reported congenital anomaly. Overall, however,
the rate of SA was noted to be similar to the background rate.
Studies Including More Than One Anti-TNFα Agent
Most studies looking at pregnancy and neonatal outcomes following exposure to
anti-TNF agents during pregnancy have not found any difference in the rates of
adverse outcomes between those exposed to these medications compared to the
women who are treated with alternative therapies [ 43 – 46 ]. In fact, one study
reported improved pregnancy and neonatal outcomes with anti-TNF monotherapy
(OR 0.57, 95% CI 0.41–0.79) and particularly with CZP use (OR 0.12, 95% CI
0.07–0.20, P < 0.001) [ 47 ]. To address the specific questions raised about the risks
of adverse pregnancy and fetal outcomes with intrauterine anti-TNF exposure, the
Multicenter National Prospective Study of Pregnancy in Inflammatory Bowel
Disease and Neonatal Outcomes (PIANO) registry was created [ 48 ]. The study
cohorts are divided into groups based on drug exposures and, at the time of initial
data presentation, included 1052 women (337 unexposed; 265 in AZA/6MP; 102 in
IFX, ADA, or CZP; 59 on combination) and found no increased risk for adverse
pregnancy or fetal outcomes associated with use of thiopurines or anti-TNF agents;
however, there was an increased rate of infections noted at 12 months in the infants
who had been exposed to combination therapy in utero.
J.K.J. Gaidos and S.V. Kane