Lupus & antiphospholipid syndrome

Hydroxychloroquine levels in pregnancy and materno-fetal outcomes in systemic lupus erythematosus patients

Rheumatology (Oxford)Published Prospective cohort study

Authors' conclusion

In this large prospective study of pregnant SLE patients, first-trimester subtherapeutic (≤500 ng/ml) and severe non-adherent (≤200 ng/ml) HCQ levels were associated with severe maternal flares, but not with APOs.

Study context

Population
Pregnant systemic lupus erythematosus (SLE) patients in the prospective GR2 study receiving hydroxychloroquine (HCQ), with ≥1 first-trimester whole-blood HCQ assaymedian age 32.1 years
Participants
174 patients
Exposure
First-trimester HCQ whole-blood levels: subtherapeutic (≤500 ng/ml) vs >500 ng/ml; non-adherent (≤200 ng/ml) vs >200 ng/ml
Outcome
Maternal flares during 2nd and 3rd trimesters, and APOs (fetal/neonatal death, placental insufficiency with preterm delivery, small-for-gestational-age neonates)
Methodological detailssecondary analysis of the prospective GR2 study
  • Secondary analysis of the prospective GR2 study

Main finding

As reported in the abstract

APOs by first-trimester HCQ level

HCQ ≤500 ng/ml vs HCQ >500 ng/ml: P = 0.19 · HCQ ≤200 ng/ml vs HCQ >200 ng/ml: P = 0.71

APOs overall: 28 patients
16.1%
Maternal flares overall: 30 patients
17.2%

Observational data: associations, not effects.

Further findings

Severe maternal flares by first-trimester HCQ level — HCQ ≤500 ng/ml vs HCQ >500 ng/ml

P = 0.02

OutcomeP value
Severe maternal flares by first-trimester HCQ levelHCQ ≤200 ng/ml vs HCQ >200 ng/mlP = 0.04
Severe maternal flares by first-trimester HCQ level — Severe flares overall: 4 patients
2.3%

Original publication

Hydroxychloroquine levels in pregnancy and materno-fetal outcomes in systemic lupus erythematosus patients. Rheumatology (Oxford). Published 5 June 2024. doi:10.1093/rheumatology/keae302

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