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. 2019 Jan;46(1):57-63.
doi: 10.3899/jrheum.180158. Epub 2018 Oct 1.

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

Stephen J Balevic  1   2 , Michael Cohen-Wolkowiez  3   4 , Amanda M Eudy  3   4 , Thomas P Green  3   4 , Laura E Schanberg  3   4 , Megan E B Clowse  3   4
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Hydroxychloroquine Levels throughout Pregnancies Complicated by Rheumatic Disease: Implications for Maternal and Neonatal Outcomes

Stephen J Balevic et al. J Rheumatol. 2019 Jan.

Abstract

Objective: Pregnancies 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.

Methods: We 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.

Results: We 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.

Conclusion: With 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.

Keywords: HYDROXYCHLOROQUINE; PREGNANCY; SYSTEMIC LUPUS ERYTHEMATOSUS.

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Figure 1:. SLE Disease Activity by HCQ Level
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References

    1. Clowse ME. Lupus activity in pregnancy. Rheum Dis Clin North Am. 2007;33:237–52, v. - PMC - PubMed
    1. Peart E, Clowse ME. Systemic lupus erythematosus and pregnancy outcomes: an update and review of the literature. Curr Opin Rheumatol 2014;26:118–23. - PubMed
    1. Ostensen M, Andreoli L, Brucato A, Cetin I, Chambers C, Clowse ME, et al. State of the art: Reproduction and pregnancy in rheumatic diseases. Autoimmun Rev 2015;14:376–86. - PubMed
    1. Clowse ME. Managing contraception and pregnancy in the rheumatologic diseases. Best Pract Res Clin Rheumatol 2010;24:373–85. - PubMed
    1. de Man YA, Hazes JM, van der Heide H, Willemsen SP, de Groot CJ, Steegers EA, et al. Association of higher rheumatoid arthritis disease activity during pregnancy with lower birth weight: results of a national prospective study. Arthritis Rheum 2009;60:3196–206. - PubMed

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