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.