Pregnancy and Humira usuage

From ACR:

Methods: Beginning in December, 2003, the OTIS Autoimmune Diseases in
Pregnancy Project has conducted a North American pregnancy registry
study for adalimumab. Using a prospective cohort study design, women
with RA who have been treated with adalimumab for some period of time
in the first trimester of pregnancy are enrolled early in gestation
and are followed to one year postpartum. Pregnancy outcomes are
compared to those in a disease-matched group of pregnant women with RA
who have not been treated with adalimumab, and a non-diseased group of
women who neither have RA nor have been treated with adalimumab. In
addition to the cohort study, the OTIS registry investigators also
collect both prospective and retrospective information on
adalimumab-exposed pregnancies that do not meet the criteria for
enrollment in the cohort.
Results: As of April 1, 2006, 69 women have enrolled in the
prospective cohort study. To date, 49 pregnancies have been completed;
no subjects have been lost-to-follow-up. Of the 49 completed
pregnancies, 6 women had first-trimester adalimumab exposure, 34 are
in the disease-matched comparison group, and 9 are in the non-diseased
comparison group. All 6 adalimumab-exposed pregnancies resulted in
full-term deliveries of live born singleton infants with no major
structural defects. Mean birth weight of the adalimumab-exposed
infants (3329 g ± SD 494) was similar to full term infants in the
disease-matched comparison group (3421 g ± SD 431) and the
non-diseased comparison group (3371 g ± SD 572) (p = 0.77). Similarly,
there were no significant differences between groups in either birth
length or head circumference. An additional 11 women with
first-trimester adalimumab exposure were ascertained prospectively but
did not meet the cohort criteria (3 enrolled late in pregnancy; 8 were
treated with adalimumab for Crohn’s or diseases other than RA). Of
these, 5 outcomes are known: one twin pregnancy resulted in
spontaneous abortion of one fetus while the other infant was delivered
prematurely and was diagnosed with congenital hip dysplasia. The
remaining 4 pregnancies resulted in healthy full-term infants with no
major structural defects reported.
Conclusions: Based on these preliminary data, no concerns have been
raised regarding increased risks for adverse pregnancy outcomes
associated with early pregnancy exposure to adalimumab. Firm
conclusions await accumulation of sufficient sample size in the cohort
study.