In comparison to tumor necrosis factor inhibitors, safety outcomes of other biologics taken in pregnancy by women with autoimmune diseases are limited, and identification of fetal and neonatal adverse drug reactions is still primarily dependent on post-marketing surveillance.

Based on a disproportionality analysis of VigiBase® (the world's largest pharmacovigilance database) and after the exclusion of reports with known concomitant use of teratogenic drugs, strong significant signals were identified for musculoskeletal and connective tissue disorders with anakinra, canakinumab, and abatacept, and for immune system disorders with canakinumab and rituximab.

After the exclusion of reports with steroids, there was a strong significant disproportionality signal for neonatal infections with belimumab.