Study Finds Hydroxychloroquine Use in Early Pregnancy Safe for SLE and RA Patients

by Ella

A recent study published in Rheumatology suggests that the use of hydroxychloroquine (HCQ) during the first trimester of pregnancy is not associated with major congenital malformations (MCMs) among individuals with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).


Given the heightened risk of adverse outcomes in pregnancies involving SLE or RA patients, understanding the impact of pharmacological treatments on maternal and fetal health is crucial. Although HCQ is generally considered safe during pregnancy, concerns persist regarding its potential teratogenic effects due to its ability to cross the placenta and affect DNA synthesis. To address these concerns, researchers conducted a population-based cohort study to evaluate the risk of MCMs associated with HCQ exposure during early pregnancy in SLE and RA patients.


The study utilized data from the Swedish Medical Birth Register and the Swedish National Patient Register spanning from August 2006 to December 2021. Singleton births resulting from pregnancies of SLE or RA patients were included in the analysis.


Results showed that among pregnancies exposed to HCQ during the first trimester, there was no significant association with the risk of MCMs compared to unexposed pregnancies. The study included 454 HCQ-exposed pregnancies and 553 unexposed pregnancies in the SLE cohort, and 144 exposed pregnancies and 2356 unexposed pregnancies in the RA cohort.


While exposed pregnancies showed higher levels of education and lower rates of first-trimester smoking, they also exhibited a greater burden of comorbidities and increased medication use. The majority of exposed pregnancies had a daily HCQ dose of less than 300 mg.

Cardiac malformations were the most common type of MCM observed, followed by urinary tract malformations. However, no clear patterns of malformations were identified among affected births.

Adjusted analyses indicated a slightly higher but statistically insignificant risk of MCMs in the exposed group from both the SLE and RA cohorts. Further analyses based on HCQ dose did not reveal any significant associations.

The study authors emphasized the importance of healthcare providers thoroughly assessing the risk-benefit ratio of HCQ and effectively communicating with mothers to facilitate informed decision-making, ultimately optimizing maternal and fetal health outcomes. However, the study’s limitations, including potential underestimation of MCM risk and reduced generalizability to populations outside of Sweden, were acknowledged.

In conclusion, the study provides reassurance regarding the safety of HCQ use during early pregnancy for individuals with SLE or RA, highlighting the need for careful consideration and individualized management approaches in clinical practice.


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