Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2022 Mar;9(1):e000651.
doi: 10.1136/lupus-2021-000651.

Hydroxychloroquine in the pregnancies of women with lupus: a meta-analysis of individual participant data

Megan E B Clowse  1 , Amanda M Eudy  2 , Stephen Balevic  3   4 , Gillian Sanders-Schmidler  5 , Andrzej Kosinski  6 , Rebecca Fischer-Betz  7 , Dafna D Gladman  8 , Yair Molad  9 , Cecilia Nalli  10 , Abir Mokbel  11 , Angela Tincani  12 , Murray Urowitz  13 , Caroline Bay  14 , Megan van Noord  15 , Michelle Petri  16
Affiliations
Meta-Analysis

Hydroxychloroquine in the pregnancies of women with lupus: a meta-analysis of individual participant data

Megan E B Clowse et al. Lupus Sci Med. 2022 Mar.

Abstract

Objective: Multiple guidelines recommend continuing hydroxychloroquine (HCQ) for SLE during pregnancy based on observational data. The goal of this individual patient data meta-analysis was to identify the potential benefits and harms of HCQ use within lupus pregnancies.

Methods: Eligible studies included prospectively collected pregnancies in women with lupus. After a systematic literature search, seven datasets meeting inclusion criteria were obtained. Pregnancy outcomes and lupus activity were compared for pregnancies with a visit in the first trimester in women who did or did not take HCQ throughout pregnancy. Birth defects were not systematically collected. This analysis was conducted in each dataset, and results were aggregated to provide a pooled OR.

Results: Seven cohorts provided 938 pregnancies in 804 women. After selecting one pregnancy per patient with a first trimester visit, 668 pregnancies were included; 63% took HCQ throughout pregnancy. Compared with pregnancies without HCQ, those with HCQ had lower odds of highly active lupus, but did not have different odds of fetal loss, preterm delivery or pre-eclampsia. Among women with low lupus activity, HCQ reduced the odds of preterm delivery.

Conclusions: This large study of prospectively-collected lupus pregnancies demonstrates a decrease in lupus activity among woman who continue HCQ through pregnancy and no harm to pregnancy outcomes. Like all studies of HCQ in lupus pregnancy, this study is confounded by indication and non-adherence. As this study confirms the safety of HCQ and diminished SLE activity with use, it is consistent with current recommendations to continue HCQ throughout pregnancy.

Keywords: Epidemiology; Health services research; Lupus Erythematosus, Systemic.

PubMed Disclaimer

Conflict of interest statement

Competing interests: MC: Funding: AHRQ, Arthritis Foundation; Grants: GSK; Consulting and Advisory Board: UCB. AE: Grant funding: NIH NCATS Award 1KL2TR002554. SB: Grants: NIH, US FDA, PCORI, RRF, CARRA; Consulting: UCB; Travel: FDA; Leadership: CARRA Assistant Scientific Director. DDG: Grants and/or consulting fees from AstraZeneca; Leadership: Member of the Systemic Lupus International Collaborating Clinics group; served on the Medical advisory board of the Lupus foundation of America. MAP: Grant NIH RO-1 AR069572.

Figures

Figure 1
Figure 1
Flow diagram of search to identify eligible cohorts. IPD, independent patient data; PI, Principal Investigator.
Figure 2
Figure 2
Directed acyclic graph demonstrating the influence of confounders on hydroxychloroquine (HCQ) use and pregnancy outcomes. Adjustments were made for disease activity and lupus nephritis, as both influence HCQ prescription and pregnancy outcomes. While hypertension, race and maternal age impact pregnancy outcomes, they do not strongly influence HCQ prescription, so adjustment is not required in this analysis. Year of pregnancy could impact both HCQ prescription and pregnancy outcomes based on changes in practice over time; however, the lead physicians in each study did not significantly alter HCQ prescribing habits during the study period so this was excluded from the analysis. APS, antiphospholipid syndrome.
Figure 3
Figure 3
Forest plots for the effect of hydroxychloroquine (HCQ) use on pregnancy outcomes in women with SLE.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Canadian Hydroxychloroquine Study Group . A randomized study of the effect of withdrawing hydroxychloroquine sulfate in systemic lupus erythematosus. N Engl J Med 1991;324:150–4. 10.1056/NEJM199101173240303 - DOI - PubMed
    1. Tsakonas E, Joseph L, Esdaile JM, et al. . A long-term study of hydroxychloroquine withdrawal on exacerbations in systemic lupus erythematosus. The Canadian hydroxychloroquine Study Group. Lupus 1998;7:80–5. 10.1191/096120398678919778 - DOI - PubMed
    1. Buchanan NM, Toubi E, Khamashta MA, et al. . Hydroxychloroquine and lupus pregnancy: review of a series of 36 cases. Ann Rheum Dis 1996;55:486–8. 10.1136/ard.55.7.486 - DOI - PMC - PubMed
    1. Parke AL, Rothfield NF. Antimalarial drugs in pregnancy--the North American experience. Lupus 1996;5 Suppl 1:67–9. 10.1177/0961203396005001151 - DOI - PubMed
    1. Levy RA, Vilela VS, Cataldo MJ, et al. . Hydroxychloroquine (HCQ) in lupus pregnancy: double-blind and placebo-controlled study. Lupus 2001;10:401–4. 10.1191/096120301678646137 - DOI - PubMed

Publication types

MeSH terms