Congenital malformations
There were 28 eligible studies in the congenital malformation
meta-analysis. There were 1288762 infants in this cohort, (7811 born to
women using biologics in pregnancy, 29171 infants born to women with CID
who were not treated with biologics in pregnancy and 1251780 infants
born to women who were CID free) (Table 1). The proportion of congenital
malformations in the treated group was 4% (95% CI 0.03-0.04), the
disease matched group was 4% (0.03 to 0.05) and the disease free group
4% (0.03 to 0.05). No differences were observed in proportions between
disease matched compared with disease treated women (p=0.238, nor in
disease free compared with disease treated women (p=0.579 Figure 1 and
Table S1).
Sub analysis by chronic inflammatory disease type did not significantly
change results. Those women with IBD treated with biologics had a
proportion of congenital malformations of 4% (95% CI 0.02 to 0.05)
compared to CID overall having 4% (0.02 to 0.06) and RA alone of 4%
(0.02 to 0.05) (Figure S5).