Evidence map›Paper›PMID 30275257›Full record

ArticleThe Journal of rheumatology2019

Hydroxychloroquine Levels throughout Pregnancies Complicated by Rheumatic Disease: Implications for Maternal and Neonatal Outcomes.

Stephen J Balevic, Michael Cohen-Wolkowiez, Amanda M Eudy, Thomas P Green, Laura E Schanberg, Megan E B Clowse

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of rheumatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  9. The relationship between hydroxychloroquine plasma concentration and COVID-19 outcomes in rheumatoid arthritis patients in Saudi Arabia.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022
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  12. Hydroxychloroquine in systemic lupus erythematosus: overview of current knowledge.Therapeutic advances in musculoskeletal disease · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Stephen J BalevicFrom the departments of Internal Medicine and Pediatrics, Duke University, and Duke Clinical Research Institute, Durham, North Carolina; Department of Pediatrics, Children's Hospital of Chicago, Chicago, Illinois, USA. Stephen.balevic@duke.edu.ORCID 0000-0002-4016-1680
Michael Cohen-WolkowiezFrom the departments of Internal Medicine and Pediatrics, Duke University, and Duke Clinical Research Institute, Durham, North Carolina; Department of Pediatrics, Children's Hospital of Chicago, Chicago, Illinois, USA.
Amanda M EudyFrom the departments of Internal Medicine and Pediatrics, Duke University, and Duke Clinical Research Institute, Durham, North Carolina; Department of Pediatrics, Children's Hospital of Chicago, Chicago, Illinois, USA.
Thomas P GreenFrom the departments of Internal Medicine and Pediatrics, Duke University, and Duke Clinical Research Institute, Durham, North Carolina; Department of Pediatrics, Children's Hospital of Chicago, Chicago, Illinois, USA.
Laura E SchanbergFrom the departments of Internal Medicine and Pediatrics, Duke University, and Duke Clinical Research Institute, Durham, North Carolina; Department of Pediatrics, Children's Hospital of Chicago, Chicago, Illinois, USA.
Megan E B ClowseFrom the departments of Internal Medicine and Pediatrics, Duke University, and Duke Clinical Research Institute, Durham, North Carolina; Department of Pediatrics, Children's Hospital of Chicago, Chicago, Illinois, USA.
Duke Medical Center · USDuke University · US

Funding

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
NIGMS NIH HHS T32 GM086330
6 · The paper itself

Abstract

objectivePregnancies in women with active rheumatic disease often result in poor neonatal outcomes. Hydroxychloroquine (HCQ) reduces disease activity and flares; however, pregnancy causes significant physiologic changes that may alter HCQ levels and lead to therapeutic failure. Therefore, our objective was to evaluate HCQ concentrations during pregnancy and relate levels to outcomes.

methodsWe performed an observational study of pregnant patients with rheumatic disease who were taking HCQ from a single center during 2013-2016. Serum samples were analyzed using high-performance liquid chromatography/mass spectrometry. Primary HCQ exposure was categorized as nontherapeutic (≤ 100 ng/ml) or therapeutic (> 100 ng/ml). Categorical outcomes were analyzed using Fisher's exact test and continuous outcomes using linear regression models, Wilcoxon signed-rank test, Kruskal-Wallis test, t test, and ANOVA.

resultsWe analyzed 145 samples from 50 patients with rheumatic disease, 56% of whom had systemic lupus erythematosus (SLE). HCQ concentration varied widely among individuals at each trimester. Mean physician's global assessment scores in patients with SLE were significantly higher in those with average drug levels ≤ 100 ng/ml compared to > 100 ng/ml (0.93 vs 0.32, p = 0.01). Of patients with SLE, 83% with average drug levels ≤ 100 ng/ml delivered prematurely (n = 6), compared to only 21% with average levels > 100 ng/ml (n = 19; p = 0.01). HCQ levels were not associated with prematurity or disease activity in non-SLE patients.

conclusionWith both high and low HCQ levels associated with preterm birth and disease activity in SLE, further study is necessary to understand HCQ disposition throughout pregnancy and to clarify the relationship between drug levels and outcomes.

Indexed as

AdultAntirheumatic AgentsFemaleHumansHydroxychloroquineInfant, NewbornLupus Erythematosus, SystemicPregnancyPregnancy ComplicationsPregnancy OutcomeAntirheumatic AgentsHydroxychloroquineHYDROXYCHLOROQUINEPREGNANCYSYSTEMIC LUPUS ERYTHEMATOSUS

Identifiers

PMID30275257
PMCPMC6314916
OpenAlexW2894901334

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.