Maternal and neonatal outcomes associated with biologic exposure before and during pregnancy in women with inflammatory systemic diseases: a systematic review and meta-analysis of observational studies

Abstract

Objective To determine the association between exposure to biologics in pregnant women with inflammatory systemic diseases and maternal and neonatal outcomes through a meta-analysis of findings from studies identified in a systematic review. Methods We conducted a systematic review of Medline, Embase, and Cochrane Database of Systematic Reviews to identify observational studies assessing the perinatal impacts of biologic in women with inflammatory systemic disease. Findings were meta-analysed across included studies with random-effects models. Crude risk estimates and, where possible, adjusted risk estimates were pooled to determine the impact on results when confounding is addressed. Results Overall, 24 studies were included in the meta-analysis. Meta-analyses of crude risk estimates resulted in pooled odds ratios (OR) for the association of biologic use during pregnancy and the following respective outcomes: congenital anomalies (1.30, 95% CI: 1.02, 1.67), preterm birth (OR 1.61, 95% CI: 1.37, 1.89), and low birth weight (OR 1.68, 95% CI: 1.21, 2.31). However, in pooled analyses of adjusted risk estimates we observed that the association between biologics use during pregnancy in disease-matched exposed and unexposed pregnant women was no longer statistically significant for congenital anomalies (adjusted OR 1.18, 95% CI: 0.88, 1.57). Conclusion Pooled results from studies reporting adjusted risk estimates showed no increased risk of congenital anomalies associated with biologics use, suggesting that increased rates of adverse outcomes may be due to disease activity itself or other confounders.

Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review

“…Regarding the association of CMs, preterm birth, and birth weight with biologic use during pregnancy, a recent meta-analysis by Tsao et al also showed no increased odds ratios [11]. Nonetheless, it should be considered that the methods in the two studies are different.…”

“…A PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) [ 11 ] guideline was followed in the design of this study.…”

“…However, it is important to provide up-to-date knowledge based on published data after this period. In this regard, a meta-analysis that included data from 24 studies was published by Tsao et al, in which the authors pooled the available evidence to assess the impact of biologic therapy during pregnancy [11]. This current systematic review aimed to update the data on the impact of maternal exposure to biological therapy by focusing specifically on miscarriages and (major) CMs.…”

Pregnancy and Neuromyelitis Optica Spectrum Disorder – Reciprocal Effects and Practical Recommendations: A Systematic Review

“…• Immunosuppressive Agents: Along with corticosteroids, other immunosuppressive agents form the mainstay of treatment of initial attacks and relapses. Azathioprine is a relatively safe option for use during pregnancy and lactation (49,61), despite indications of a slightly increased risk of adverse outcomes, and should be initiated or continued, regardless of gestational age, should the clinical condition require pharmacologic management (62,63). Tacrolimus has been used effectively, but is not among the first line treatments approved for NMOSD.…”

“…Monoclonal antibodies: are being increasingly used in pregnancy. A recent systematic review of systemic autoimmune conditions showed that there is no association between their use during pregnancy and the risk of congenital anomalies or preterm deliveries compared with disease matched unexposed pregnant women ( 64 ). Owing to their high molecular weight, only small amounts are likely to be transferred into breast milk.…”