Women with immune-mediated diseases receiving anti-tumor necrosis factor (TNF)-alpha agents had significantly higher risks of preterm birth, spontaneous abortion, and low birth weight vs. the general population, a study published in the Journal of Autoimmunity found.
For female patients with rheumatoid arthritis, ankylosing spondylitis, and inflammatory bowel disease (IBD), the safety of anti-TNF-alpha agents during pregnancy is still unclear. Researchers from The University of Chicago Medicine, Northwestern University, and the Kagoshima University Graduate School of Medical and Dental Sciences aimed to evaluated the risk of pregnancy-related outcomes in patients with immune-mediated diseases receiving treatment with anti-TNF-alpha agents.
A total of 13 studies were identified for the analysis. Direct and network meta-analyses were performed between anti-TNF-alpha users, non-users, and the general population.
When compared to the general population, the analysis found anti-TNF-alpha users had a non-significant trend towards a reduced rate of live birth (odds ratio [OR] 0.38, 95% CI: 0.13–1.13; P=0.081) and also had a significantly higher risk of preterm birth (OR 2.62, 95% CI: 2.12–3.23; P<0.0001), spontaneous abortion (OR 4.08, 95% CI: 1.12–14.89; P=0.033), and low birth weight (OR 5.95, 95% CI: 1.17–30.38; P=0.032). The analysis did not however indicate an increased risk of anomalies (OR 1.46, 95% CI: 0.84–2.56; P=0.18).
Studies that compared anti-TNF-alpha users to non-users found no significant differences in the rates of live birth and pregnancy-related complications.
When comparing non-anti-TNF-alpha users to the general population, the risk of spontaneous abortion was higher (OR 2.60, 95% CI: 1.08-6.27; P=0.033) but no significant differences were seen in the rates of live birth and other pregnancy-related complications.
Overall, females with immune-mediated diseases treated with anti-TNF-alpha agents had comparable outcomes to non-users. However, compared to the general population, significantly increased risks of preterm birth, spontaneous abortion, and low birth weight were seen. Study authors conclude that these findings may help increase awareness among clinicians managing female patients of reproductive age.
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