TOPLINE:
A study reveals that hydroxychloroquine levels during the first trimester in pregnant women with systemic lupus erythematosus (SLE) are linked to severe maternal flares but not to adverse pregnancy outcomes.
METHODOLOGY:
- Researchers included pregnant women with SLE (median age, 32.1 years; median duration of disease, 8.3 years) who were enrolled in an ongoing French prospective observational study and were receiving hydroxychloroquine.
- The study assessed hydroxychloroquine blood levels during the first trimester. It defined severe nonadherence as having levels < 200 ng/mL and classified levels < 500 ng/mL as subtherapeutic.
- Primary outcomes were maternal flares during pregnancy and adverse pregnancy outcomes, including fetal/neonatal death and preterm delivery.
TAKEAWAY:
- Overall, 32 women experienced at least one flare during the second and third trimester; four had severe flares.
- The rates of severe maternal SLE flares were significantly associated with hydroxychloroquine levels in the first trimester that were classified as subtherapeutic (8.8% vs 0.7% with above subtherapeutic levels, P = .02) and severely nonadherent (13.3% vs 1.3% with above severely nonadherent levels, P = .04).
- There was no significant difference in adverse pregnancy outcomes by hydroxychloroquine level, suggesting its specific effect on maternal health rather than fetal health.
IN PRACTICE:
According to the authors, “this study supports hydroxychloroquine blood level assessment in pregnant women with SLE, as a predictor of severe maternal disease activity in pregnancy.”
SOURCE:
The study was led by Gelsomina Alle, MD, Assistance Publique-Hôpitaux de Paris, Paris, France. It was published online in Rheumatology.
LIMITATIONS:
The study’s sample size limited the ability to perform multivariate analyses for severe flares. Patients had to have an ongoing pregnancy at 12 weeks to be included, potentially excluding those with early pregnancy loss. The study only observed first-trimester hydroxychloroquine levels, not accounting for adherence variations throughout pregnancy.
DISCLOSURES:
The study funding source was not disclosed. Several authors declared financial relationships with pharmaceutical companies, including research support and consulting fees.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.