First-trimester hydroxychloroquine use adds no significant risk for birth defects
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Key takeaways:
- The risk for birth defect were not statistically significantly higher in pregnancies with lupus or RA exposed to hydroxychloroquine.
- Benefits of hydroxychloroquine may outweigh risks during pregnancy, the researchers wrote.
Hydroxychloroquine use for systemic lupus erythematosus or rheumatoid arthritis in the first trimester of pregnancy does not significantly increase the risk for major congenital malformations, according to data published in Rheumatology.
“Hydroxychloroquine has long been recommended and used for pregnant individuals with rheumatic diseases, including systemic lupus and rheumatoid arthritis,” Ngoc V. Nguyen, MSc, a PhD candidate at the Karolinska Institute, in Sweden, told Healio.
“However, in 2020 a large study using claims data in the United States showed that hydroxychloroquine use during the first trimester among pregnant individuals with a rheumatic disease is associated with a small but statistically significant increased risk for major birth defects,” he added. “Realizing the clinical importance of this topic, we investigated the association in a different population by using nationwide and high-quality Swedish health care registers.”
Using data from the Swedish Medical Birth Register and Swedish National Patient Register, Nguyen and colleagues conducted a population-based cohort study of all singleton live births from patients with SLE or RA from August 2006 to December 2021. The study included 1,007 births from patients with SLE, 452 of which featured exposure to hydroxychloroquine, and 2,500 births from those with RA, 144 of which were exposed to hydroxychloroquine.
Pregnancies were considered exposed to hydroxychloroquine if at least one prescription was filled within 90 days after the last menstrual period. Risk for major congenital malformations within 1 year of birth was estimated using modified Poisson regression models.
According to the researchers, births with hydroxychloroquine exposure in both the SLE (RR = 1.29; 95% CI, 0.65-2.56) and RA (RR = 1.32; 95% CI, 0.56-3.13) cohorts demonstrated a slightly higher, but not statistically significant, risk for major congenital malformations. Meanwhile, a pooled estimate found hydroxychloroquine overall “not statistically significantly associated with” risk for major congenital malformations (RR = 1.3; 95% CI, 0.76-2.23), the researchers wrote. Sensitivity analyses examining longer-term windows for exposure and outcome ascertainment yielded “similar” estimates, they added.
“For clinicians and patients, our study reassures the fetal safety of hydroxychloroquine and supports the current recommendation that it should be used for pregnant women with rheumatic disease unless contraindicated, especially systemic lupus, given that the potential risks may not outweigh hydroxychloroquine’s established benefits during pregnancy,” Nguyen said.
According to the researchers, the study’s limitations include the possibility that the findings could “stem from limited power,” given that there were few major congenital malformation events. Additionally, the filling of hydroxychloroquine prescriptions may not accurately reflect actual use of the drug.
“These reassuring findings should be spread to the scientific community and especially to patients and their treating clinicians,” Nguyen said. “It is really important for clinicians to thoroughly discuss the risks and benefits of [hydroxychloroquine] regarding disease control, and mother and infant safety, with patients in [shared clinical decision-making].”
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