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[Evolution of biological management during pregnancy: from uncertainty to evidence in rheumatoid arthritis]. | LitMetric

[Evolution of biological management during pregnancy: from uncertainty to evidence in rheumatoid arthritis].

Medicina (B Aires)

Instituto de Investigaciones Clínicas Quilmes, Buenos Aires, Argentina.

Published: August 2025


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Article Abstract

Over the last decade, the management of biologic therapies during pregnancy in rheumatoid arthritis (RA) patients has significantly evolved, shifting from uncertainty to robust evidence. Initially, in 2006, the use of these treatments was discouraged due to insufficient safety data and potential fetal risks. Notable cases, such as the fatal disseminated BCG infection in a newborn exposed to infliximab, highlighted the importance of neonatal monitoring and led to guidelines restricting live-virus vaccinations until 12 months. Later studies demonstrated significant differences in placental transfer among biologics: infliximab and adalimumab exhibit high transplacental transfer, whereas certolizumab pegol shows minimal transfer due to its molecular structure. Recent observational studies and meta-analyses have not demonstrated significant increases in spontaneous abortions, major congenital defects, or serious infections among offspring exposed to anti-TNF biologics. However, certain studies suggest a slight elevation in congenital defects, potentially attributable to methodological biases. Current international guidelines recommend the continued use of anti-TNF biologics throughout pregnancy, with individualized evaluation during the third trimester for biologics containing the Fc fragment. Evidence remains limited for non-anti-TNF biologics and JAK inhibitors, underscoring the need for further research. Postnatal monitoring remains critical, particularly deferring live attenuated vaccines in exposed infants until 6-12 months. In summary, accumulated evidence now supports the relative safety of continuing anti-TNF biologics throughout pregnancy in RA patients but emphasizes the necessity for ongoing long-term safety assessments.

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