HYdroxychloroquine to Improve Pregnancy Outcome in Women with AnTIphospholipid Antibodies (HYPATIA) Protocol: A Multinational Randomized Controlled Trial of Hydroxychloroquine versus Placebo in Addition to Standard Treatment in Pregnant Women with Antiphospholipid Syndrome or Antibodies

Schreiber, Karen; Breen, Karen; Cohen, Hannah; Jacobsen, Søren; Middeldorp, Saskia; Pavord, Sue; Regan, Lesley; Roccatello, Dario; Robinson, S.; Sciascia, Savino; Seed, Paul; Watkins, Linda R.; Hunt, Beverley J.

doi:10.1055/s-0037-1603359

Cited by 87 publications

(51 citation statements)

References 59 publications

(78 reference statements)

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“…Three upcoming trials (not yet recruiting) on women with autoimmune diseases will aim to evaluate the impact of HCQ in addition to conventional therapy in the prevention of obstetrical complications (ILIFE trial: NCT03671174; HYDROSAPL; and HYPATIA).…”

Section: Clinical Studies On Hcq In Rm and Ementioning

confidence: 99%

Hydroxychloroquine may be beneficial in preeclampsia and recurrent miscarriage

Moreuil

Alavi

Pasquier

2019

Brit J Clinical Pharma

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Recurrent miscarriage (RM) and vasculoplacental disorders, such as preeclampsia (PE), affect women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with both RM and PE. To date, there is no effective or optimal therapeutic approach for these conditions. Notably, aspirin use is only partially effective in the prevention of PE. Hydroxychloroquine (HCQ) has demonstrated beneficial effects on disease flares, pregnancy outcomes and cardiovascular impairment in systemic erythaematosus lupus (SLE) through its immunomodulatory, vasculoprotective and antithrombotic properties. Here, in the context of the underlying physiological dysregulation associated with PE and RM, the beneficial properties and potential therapeutic efficacy of HCQ are reviewed in anticipation of the results of current and future trials. Two related trials addressing RM in the absence of maternal autoimmune disease are ongoing. Other trials addressing pregnancy outcomes in the presence of maternal autoimmune disease are forthcoming. In this review, we hypothesise that the immunological and endothelial effects of HCQ may be beneficial in the context of PE and RM, regardless of the maternal autoimmune status. K E Y W O R D S hydroxychloroquine, pregnancy, preeclampsia, recurrent miscarriage

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Section: Clinical Studies On Hcq In Rm and Ementioning

confidence: 99%

Hydroxychloroquine may be beneficial in preeclampsia and recurrent miscarriage

Moreuil

Alavi

Pasquier

2019

Brit J Clinical Pharma

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“…They were also able to show a decreased rate of preeclampsia and/or HELLP syndrome in the group receiving HCQ [55]. Schreiber and colleagues initiated the HYPATIA protocol, a randomized controlled trial of women with antiphospholipid antibodies, comparing HCQ versus placebo in addition to conventional treatment with regard to pregnancy outcomes [51]. Previous data from this research group has shown that pregnancy duration was longer and fetal losses after 10 weeks of gestation less frequent in patients with antiphospholipid antibodies receiving HCQ than in controls not treated with HCQ.…”

Section: Hcqa Promising Treatment For Preeclampsiamentioning

confidence: 99%

Hydroxychloroquine as a Preventive and Therapeutic Option in Preeclampsia – a Literature Review

Deharde

Klockenbusch

Schmitz

et al. 2020

Geburtshilfe Frauenheilkd

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Preeclampsia is one of the most feared complications of pregnancy and puerperium and represents a serious threat to mother and child. In addition, a history of preeclampsia increases the risk of future cardiovascular events. New diagnostic and therapeutic approaches are needed. New therapeutic options are currently being discussed, one of which is the administration of hydroxychloroquine. It is an antimalarial drug which is also used to treat rheumatological disease and its use in pregnancy is considered safe. A reduced incidence of preeclampsia in patients with selected rheumatological disorders after administration of hydroxychloroquine has already been shown; however, the case numbers are very low. Neither the full pathogenesis of preeclampsia nor the exact modes of action of hydroxychloroquine have been completely elucidated, but there are several common features which make hydroxychloroquine a promising option for the prevention and treatment of preeclampsia. Further research, especially prospective, randomized controlled trials, is needed to prove its efficacy. This review discusses the pathogenesis of preeclampsia and gives an overview of new options for its prevention and treatment, including the administration of hydroxychloroquine in pregnancy.

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“…18,19 There is an ongoing randomized, placebocontrolled trial examining hydroxychloroquine for this indication; if the final results of this study are consistent with those of prior observational studies, there may be a shift in screening and management of this population. 20 We found that only a small minority of women with severe early onset hypertensive disease of pregnancy are being screened for APS via aPL testing in the inpatient setting at the time of initial diagnosis and that those who deliver at earlier gestational ages are more likely to undergo screening. Despite the known obstetric and thrombotic complications of APS, there is little consensus regarding screening for this disease and for managing women with obstetric-only APS.…”

Section: Discussionmentioning

confidence: 82%

Early Onset Severe Hypertensive Disease in Pregnancy and Screening for Antiphospholipid Syndrome

Sobhani

Shulman

Tran

et al. 2020

AJP Rep

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Objective Although preterm delivery (PTD) before 34 weeks for severe hypertensive disease is a diagnostic criterion for antiphospholipid syndrome (APS), there is no consensus regarding testing for antiphospholipid antibodies (aPL) in this setting. We aim to describe the frequency of and the characteristics associated with inpatient aPL testing in this population. Study Design In this retrospective study of PTD before 34 weeks for severe hypertensive disease, charts were reviewed for aPL testing, gestational age at delivery, fetal complications, and severity of maternal disease. Wilcoxon rank-sum test, Fisher's exact, and chi-squared tests were used for analyses of continuous and categorical variables, and multivariate logistic regression for adjusted odds ratios. Results Among 133 cases, 14.3% had APS screening via aPL testing. Screened patients delivered earlier than unscreened patients (28.9 vs. 31.7 weeks, p <0.001). Each additional week of gestation was associated with a 39% decrease in the odds of screening (95% confidence interval: 0.43–0.85). There were no other differences between the groups. Conclusion APS screening after PTD for severe hypertensive disease is uncommon but more likely with earlier PTD. Despite conflicting recommendations from professional organizations, prior studies demonstrate contraceptive, obstetrical, and long-term risks associated with APS, suggesting that we should increase our screening efforts.

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HYdroxychloroquine to Improve Pregnancy Outcome in Women with AnTIphospholipid Antibodies (HYPATIA) Protocol: A Multinational Randomized Controlled Trial of Hydroxychloroquine versus Placebo in Addition to Standard Treatment in Pregnant Women with Antiphospholipid Syndrome or Antibodies

Cited by 87 publications

References 59 publications

Hydroxychloroquine may be beneficial in preeclampsia and recurrent miscarriage

Hydroxychloroquine may be beneficial in preeclampsia and recurrent miscarriage

Hydroxychloroquine as a Preventive and Therapeutic Option in Preeclampsia – a Literature Review

Early Onset Severe Hypertensive Disease in Pregnancy and Screening for Antiphospholipid Syndrome

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