Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: a systematic review and meta-analysis.

Abstract

Background: Biologic medications, specifically the TNF-α inhibitors, have become increasingly prevalent in the treatment of chronic inflammatory disease (CID) in pregnancy. Objective: To determine pregnancy outcomes in women with CID exposed to biologics during pregnancy. Search strategy: PubMed and EMBASE databases were searched through January 1998-July 2021. Selection criteria: Peer reviewed, English language cohort, case-control, cross-sectional studies, and case series which contained original data. Data collection and analysis: Two authors independently conducted data extraction and assessed study quality. A meta-analysis of proportions using a random-effects model was used to pool outcomes. Linear regression analysis was used to compare the mean of proportions of outcomes across exposure groups using the ‘treated’ group as the reference category. All studies were evaluated using an appropriate quality assessment tool described by McDonald et al. Main Results: 35 studies, 11172 pregnancies, were eligible for inclusion. Analysis showed pooled proportions for congenital malformations: treated 4%(95% CI 0.03-0.4) vs disease matched 4%(0.03-0.05).Preterm delivery treated 12%(0.10-0.14) vs disease matched 10%(0.09-0.12) Severe neonatal infection: treated 5%(0.03-0.07) vs disease matched 5%(0.02-0.07) Low birth weight: treated 10%(0.07-0.12) vs disease matched 8%(0.07-0.09) The pooled Miscarriage: treated 13%(0.10-0.15) vs disease matched 8%(0.04-0.11) Pre-eclampsia; treated 1%(0.01-0.02) vs disease matched 1%(0.00-0.01). No statistical differences in proportions were observed. Conclusion: We demonstrated comparable pregnancy outcomes in pregnancies exposed to biologics, disease matched controls and CID free pregnancies. Overall, women receiving biologics in pregnancy may be reassured regarding their safety.