Observational studyClinical pharmacokinetics2019
Pharmacokinetics of Hydroxychloroquine in Pregnancies with Rheumatic Diseases.
Observational study in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.
- Hydroxychloroquine in the pregnancies of women with lupus: a meta-analysis of individual participant data.Lupus science & medicine · 2022Pooled it
- Hydroxychloroquine levels in pregnancy and materno-fetal outcomes in systemic lupus erythematosus patients.Rheumatology (Oxford, England) · 2025Trial
- Pharmacokinetics of hydroxychloroquine in paediatric lupus: data from a novel, direct-to-family clinical trial.Lupus science & medicine · 2022Trial
- Pharmacokinetics of Certolizumab Pegol in Pregnancy: Results from the Open-Label CHERISH Study.Rheumatology and therapy · 2026Article
- A review of immunosuppressive therapy in the context of uterine VCA and pregnancy.Frontiers in transplantation · 2026Review
- Hydroxychloroquine withdrawal triggers pregnancy-associated pulmonary arterial hypertension in systemic lupus erythematosus: a case report and exploration of the Complement-EndMT axis.Frontiers in pharmacology · 2026Article
- Refining lupus management: a comprehensive review of HCQ blood levels.Rheumatology advances in practice · 2025Review
- The Role of Pharmacometrics in Advancing the Therapies for Autoimmune Diseases.Pharmaceutics · 2024Review
- Risk Assessment and Optimization for Pregnancy in Patients with Rheumatic Diseases.Diagnostics (Basel, Switzerland) · 2024Review
- The effects of hydroxychloroquine and its promising use in refractory obstetric antiphospholipid syndrome.Rheumatology international · 2024Review
- Whole blood hydroxychloroquine: Does genetic polymorphism of cytochrome P450 enzymes have a role?Clinical and experimental medicine · 2023Review
- Association Between Severe Nonadherence to Hydroxychloroquine and Systemic Lupus Erythematosus Flares, Damage, and Mortality in 660 Patients From the SLICC Inception Cohort.Arthritis & rheumatology (Hoboken, N.J.) · 2023Article
- Population Pharmacokinetics of Hydroxychloroquine Sulfate in Healthcare Workers, Given for Prophylaxis Against Coronavirus Disease 2019 (COVID-19) in India.Journal of clinical pharmacology · 2022Article
- LC-MS/MS Method for Determination of Hydroxychloroquine and Metabolites: Application in a Pharmacokinetic Study.Journal of analytical methods in chemistry · 2022Article
- Hydroxychloroquine PK and exposure-response in pregnancies with lupus: the importance of adherence for neonatal outcomes.Lupus science & medicine · 2022Article
- Optimization of hydroxychloroquine dosing scheme based on COVID-19 patients' characteristics: a review of the literature and simulations.Xenobiotica; the fate of foreign compounds in biological systems · 2021Review
- Pre-Exposure Prophylaxis for COVID-19 in Pregnant Women.International journal of general medicine · 2021Article
- Population Pharmacokinetics of Hydroxychloroquine in COVID-19 Patients: Implications for Dose Optimization.European journal of drug metabolism and pharmacokinetics · 2020Article
- Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID-19 Infection.Clinical pharmacology and therapeutics · 2020Review
- Simulated Assessment of Pharmacokinetically Guided Dosing for Investigational Treatments of Pediatric Patients With Coronavirus Disease 2019.JAMA pediatrics · 2020Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundHydroxychloroquine is an oral drug prescribed to pregnant women with rheumatic disease to reduce disease activity and prevent flares. Physiologic changes during pregnancy may substantially alter drug pharmacokinetics. However, the effect of pregnancy on hydroxychloroquine disposition and the potential need for dose adjustment remains virtually unknown.
methodsWe performed a population-pharmacokinetic analysis using samples from the Duke Autoimmunity in Pregnancy Registry from 2013 to 2016. We measured hydroxychloroquine concentration using high-performance liquid chromatography/tandem mass spectrometry and analyzed data using non-linear mixed-effect modeling. We calculated differences between pregnancy and postpartum empirical Bayesian estimates using paired t tests. We computed steady-state concentration profiles for hydroxychloroquine during pregnancy and postpartum using individual clinical data and empirical Bayesian estimates developed from the final pharmacokinetic model.
resultsWe obtained 145 serum samples from 50 patients, 25 of whom had paired pregnancy and postpartum specimens. Five subjects had average concentrations (pregnancy and postpartum) < 100 ng/mL, consistent with medication non-adherence, and were excluded. The population estimated apparent volume of distribution was 1850 L/70 kg and estimated apparent clearance was 51 L/h. Compared with postpartum, median apparent volume of distribution increased significantly during pregnancy (p < 0.001), whereas apparent clearance and 24-h area under the curve did not change.
conclusionsWe developed a one-compartment population-pharmacokinetic model for hydroxychloroquine in pregnant women with rheumatic disease. Estimates for serum CL were within the expected range for plasma in non-pregnant adults. Because CL and 24-h area under the curve did not change during pregnancy compared with postpartum, our modeling in this small cohort does not support adjusting hydroxychloroquine dose during pregnancy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.