BJOG. 2022 Jan 11. doi: 10.1111/1471-0528.17093. Online ahead of print.
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. 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. The GRADE approach was used to assess the overall certainty of evidence.
MAIN RESULTS: 35 studies, 11172 pregnancies, were eligible for inclusion. Analysis showed pooled proportions for congenital malformations: treated 0.04(95% CI 0.03-0.04; I2 77) vs disease matched 0.04(0.03-0.05. I2 86) p=0.238. Preterm delivery treated 0.04(0.10-0.14. I2 88) vs disease matched 0.10(0.09-0.12. I2 87) p=0.250. Severe neonatal infection: treated 0.05(0.03-0.07. I2 88) vs disease matched 0.05(0.02-0.07. I2 94) p=0.970. Low birth weight: treated 0.10(0.07-0.12. I2 93) vs disease matched 0.08(0.07-0.09. I2 0) p=0.241. The pooled Miscarriage: treated 0.13(0.10-0.15. I2 77) vs disease matched 0.08(0.04-0.11. I2 5) p=0.078. Pre-eclampsia; treated 0.01(0.01-0.02. I2 0) vs disease matched 0.01(0.00-0.01. I2 0). p=0.193. No statistical differences in proportions were observed. GRADE certainty of findings were low to very low.
CONCLUSION: We demonstrated comparable pregnancy outcomes in pregnancies exposed to biologics, disease matched controls and CID free pregnancies using the GRADE approach.
PMID:35014759 | DOI:10.1111/1471-0528.17093