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.