Trial reportRheumatology (Oxford, England)2025
Hydroxychloroquine levels in pregnancy and materno-fetal outcomes in systemic lupus erythematosus patients.
Trial report in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02450396 (Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Maternal systemic lupus erythematosus and the risk of congenital cardiovascular abnormalities in offspring: a systematic review and meta-analysis.Immunologic research · 2026Pooled it
- Hydroxychloroquine Exposure Intensity During Early Pregnancy and Composite Fetal Adverse Pregnancy Outcomes in Systemic Lupus Erythematosus: A Retrospective Cohort Study.Journal of clinical medicine · 2026Article
- Pharmacokinetics of Certolizumab Pegol in Pregnancy: Results from the Open-Label CHERISH Study.Rheumatology and therapy · 2026Article
- Immune microenvironment dynamics in pregnant patients with concomitant autoimmune diseases: mechanisms, challenges, and clinical significance.Military Medical Research · 2026Review
- Exposure to hydroxychloroquine in early pregnancy and incidence of pre-eclampsia and pre-term delivery in patients with systemic lupus erythematosus in Sweden: a nationwide population-based cohort study.The Lancet. Rheumatology · 2025Article
- Risk of preterm delivery and early pregnancy hydroxychloroquine use from a Californian lupus cohort.Lupus science & medicine · 2025Article
- Impact of conflicting information on the use of antirheumatic drugs in pregnancy and breastfeeding: perspectives of healthcare providers from the global PRAISE survey.Therapeutic advances in musculoskeletal disease · 2025Article
Corrections and comments
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Authors and funding
33 authors.
Funding
Abstract
objectivesData about hydroxychloroquine (HCQ) levels during pregnancy are sparse. We assessed HCQ whole-blood levels at first trimester of pregnancy as a potential predictor of maternal and obstetric/fetal outcomes in patients with systemic lupus erythematosus (SLE).
methodsWe included pregnant SLE patients enrolled in the prospective GR2 study receiving HCQ, with at least one available first-trimester whole-blood HCQ assay. We evaluated several cut-offs for HCQ whole-blood levels, including ≤200 ng/ml for severe non-adherence. Primary outcomes were maternal flares during the second and third trimesters of pregnancy, and adverse pregnancy outcomes (APOs: fetal/neonatal death, placental insufficiency with preterm delivery, and small-for-gestational-age neonates).
resultsWe included 174 patients (median age: 32.1 years, IQR 28.8-35.2). Thirty (17.2%) patients had flares, four (2.3%) being severe. APOs occurred in 28 patients (16.1%). There were no significant differences in APOs by HCQ level for either those with subtherapeutic HCQ levels (≤500 ng/ml vs >500 ng/ml: 23.5% vs 14.3%, P = 0.19) or those with non-adherent HCQ levels (≤200 ng/ml vs >200 ng/ml: 20.0% vs 15.7%, P = 0.71). Similarly, the overall rate of maternal flares did not differ significantly by HCQ level cut-off, but patients with subtherapeutic (HCQ ≤500 ng/ml: 8.8% vs 0.7%, P = 0.02) and non-adherent HCQ levels (≤200 ng/ml: 13.3% vs 1.3%, P = 0.04) had significantly more severe flares.
conclusionIn 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.
trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT02450396.
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