Immune Checkpoint Inhibitors Not Linked to Increased Pregnancy Risks: JAMA

The study aimed to assess the risk of adverse outcomes associated with ICI exposure compared to other anticancer agents, providing valuable insights into the safety profile of these medications during pregnancy. This study was published in JAMA Network Open by Paul G. and colleagues. Existing data on the risk of adverse pregnancy outcomes associated with ICI exposure are limited, necessitating comprehensive research in this area.

The cohort study analyzed data extracted from the World Health Organization international pharmacovigilance database VigiBase, encompassing reports of pregnancy-related conditions and the use of anticancer agents. A total of 3558 reports were included in the analysis, with 91 involving exposure to immune checkpoint inhibitors (ICIs) and the remaining reports related to other anticancer drugs. The study sought to evaluate the incidence of adverse pregnancy, fetal, and newborn outcomes associated with ICI exposure compared to alternative anticancer treatments.

The key findings of the study were as follows:

• The analysis revealed that exposure to immune checkpoint inhibitors (ICIs) during pregnancy did not show an increased risk of specific adverse outcomes compared to other anticancer drugs.

• The combination of anti-PD1 plus anti-CTLA4 was associated with a significantly higher incidence of preterm birth compared to other anticancer drugs (80.0% vs 23.0%).

• Rare immune-related neonatal adverse events were identified, underscoring the need for caution in ICI use during pregnancy, particularly with certain combination therapies.

• These findings highlight the importance of careful risk assessment and monitoring in pregnant patients receiving ICIs.

The study concludes that while exposure to immune checkpoint inhibitors (ICIs) during pregnancy did not demonstrate an increased risk of specific adverse outcomes overall, caution is warranted, particularly with certain combination therapies. Healthcare providers should carefully weigh the potential benefits and risks when considering the use of ICIs in pregnant patients, with a focus on minimizing potential harm to maternal and fetal health. Further research is needed to better understand the risks associated with ICI exposure during pregnancy and to inform clinical practice guidelines and decision-making processes.

Reference:

Gougis, P., Hamy, A.-S., Jochum, F., Bihan, K., Carbonnel, M., Salem, J.-E., Dumas, E., Kabirian, R., Grandal, B., Barraud, S., Coussy, F., Hotton, J., Savarino, R., Marabelle, A., Cadranel, J., Spano, J.-P., Laas, E., Reyal, F., & Abbar, B. (2024). Immune checkpoint inhibitor use during pregnancy and outcomes in pregnant individuals and newborns. JAMA Network Open, 7(4), e245625. https://doi.org/10.1001/jamanetworkopen.2024.5625