Evidence map›Paper›PMID 38479815›Full record

ArticleRheumatology (Oxford, England)2025

Hydroxychloroquine in lupus or rheumatoid arthritis pregnancy and risk of major congenital malformations: a population-based cohort study.

Ngoc V Nguyen, Elisabet Svenungsson, Annica Dominicus, Maria Altman, Karin Hellgren, Julia F Simard, Elizabeth V Arkema

Open access · hybridAbstract read
In one paragraph

Article in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
9.2field-weighted citation impact, top 2% 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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  4. Review
  5. Observational
  6. Review
  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Ngoc V NguyenClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-4455-3171
Elisabet SvenungssonDivision of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.ORCID 0000-0003-3396-3244
Annica DominicusClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Maria AltmanClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Karin HellgrenClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0001-7149-0973
Julia F SimardClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0001-5735-9856
Elizabeth V ArkemaClinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Karolinska Institutet · SEKarolinska University Hospital · SE

Funding

Can hydroxychloroquine prevent preeclampsia and preterm delivery in lupus pregnancy?R01AR077103 · NIAMS · STANFORD UNIVERSITY · PI SIMARD, JULIA F · 2020 to 2024
$2.4M
Ingegerd Johansson Donation SLS-714651NIAMS NIH HHS R01 AR077103NIH HHS
6 · The paper itself

Abstract

objectivesTo assess the infant risk of major congenital malformations (MCM) associated with first-trimester exposure to hydroxychloroquine (HCQ) among mothers with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).

methodsThis population-based cohort study utilized Swedish nationwide registers and included all singleton births (2006-2021) among individuals with prevalent SLE or RA in Sweden. The exposure was filling ≥1 HCQ prescription during the first trimester. The outcome was infant MCM within 1 year of birth. Inverse probability of treatment weighting was applied to adjust for potential confounders (e.g. maternal smoking, body mass index, pregestational diabetes and corticosteroids). Modified Poisson regression models with robust variance were used to estimate risk ratios (RR) and 95% CI.

resultsWe included 1007 births (453 exposed) and 2500 births (144 exposed) in the SLE and RA cohorts, respectively. The MCM risks in the SLE overall cohort, exposed and unexposed groups were 3.6%, 3.7% and 3.4%, respectively. The corresponding figures in the RA cohort were 4.4%, 5.6% and 4.3%, respectively. The adjusted RRs (95% CI) were 1.29 (0.65, 2.56) in the SLE cohort, 1.32 (0.56, 3.13) in the RA cohort and 1.30 (0.76, 2.23) in the pooled analysis. The adjusted risk difference (exposed vs unexposed) was small (0.9% in SLE and 1.3% in RA). Sensitivity analyses examining different exposure and outcome windows yielded similar findings.

conclusionFirst-trimester exposure to HCQ was not associated with a significantly increased risk of MCM. HCQ's benefits may outweigh the risks in managing SLE or RA during pregnancy.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidHydroxychloroquineLupus Erythematosus, SystemicPregnancy ComplicationsAbnormalities, Drug-InducedAdultCohort StudiesFemaleHumansInfant, NewbornPregnancyPregnancy Trimester, FirstRegistriesSwedenAntirheumatic AgentsHydroxychloroquineautoimmune diseasehydroxychloroquineinverse probability of treatment weightingmajor congenital malformationsrheumatoid arthritissystemic lupus erythematosus

Identifiers

PMID38479815
PMCPMC11701318
OpenAlexW4392791116

What OpenQuestion holds

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Registered trials

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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.