Hydroxychloroquine (Indication Antiphospholipid Syndrom)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Elsenity, 2022 Egypt
2019 - 2021
Females who had a history suggestive of autoimmune Recurrent pregnancy loss (RPL) and anti-phospholipid syndrome (APS) who experienced a bad outcome with conventional treatment in previous pregnancies. Pregnant women that took Hydroxychloroquine (200mg twice daily) for at least three months before and during gestation, in addition to low-dose aspirin and low-molecular-weight heparin (LMWH). unexposed, sick
Pregnant women that took placebo for at least three months before and during gestation, in addition to low-dose aspirin and low-molecular-weight heparin (LMWH).
53 / 54
Gerde, 2021 Argentina
2004 - 2019
Caucasian women (20–43 years old) with primary obstetric antiphospholipid syndrome (OAPS) who had been refractory to classical treatment (Low dose aspirin and enoxaparin 40 mg) in their previous pregnancies. Pregnancies in women that received 400 mg pf hydroxychloroquine, 100-150 mg of aspirin (until the 36th week of gestation) and 60 mg enoxaparin daily. unexposed, sick
Pregnancies in women that received 100-150 mg of aspirin (until the 36th week of gestation) and 60 mg enoxaparin daily.
67 / 32 None of the patients received another concomitant drug, such as steroids or a higher dose of enoxaparin other than 60 mg/daily.
Latino, 2020 Argentina and France
2010 - 2017
Pregnant women diagnosed with obstetric antiphospholipid syndrome (APS) and at least one high-risk factor who attended the included centers. Patients with obstetric antiphospholipid syndrome (APS) treated with hydroxychloroquine and conventional treatment (low-dose aspirin and molecular-weight heparin). unexposed, sick
Patients with obstetric antiphospholipid syndrome (APS) treated with conventional treatment (low-dose aspirin and molecular-weight heparin).
12 / 30
Mekinian, 2015 Europe
Not specified.
Pregnancies in patients with Antiphospholipid syndrome (APS) or asymptomatic antiphospholipid (aPL) carriers. Pregnancies treated by hydroxychloroquine in patients with Antiphospholipid syndrome (APS) or asymptomatic antiphospholipid (aPL) carriers, in addition to conventional APS treatment. unexposed, sick
Pregnancies in patients with confirmed Antiphospholipid syndrome (APS) treated by conventional APS treatment (aspirin and low-molecular weighted heparin) without hydroxychloroquine.
35 / 25
Mekinian, 2016 France
2010 - 2014
Patients with clinical obstetrical Antiphospholipid syndrome (APS). Pregnancies in patients under hydroxychloroquine during pregnancy (patients with non-conventional Antiphospholipid syndrome (APS); non-APL group and confirmed APS). unexposed, sick
Pregancies in patients not under hydroxychloroquine during pregnancy (patients with non-conventional Antiphospholipid syndrome (APS); non-APL group and confirmed APS).
12 / 462 474 pregnancies in patients: 261 pregnancies which occurred in 65 patients with non-conventional APS ; 81 pregnancies of confirmed APS patients and 132 pregnancies of 31 patients from non-APL group.
Ruffatti, 2018 20 centres (Italy, France, Spain, Russia, Poland, Argentina, UK, Israel, Emirate, Austria, Portugal)
1999 - 2016
Patients with primary antiphospholipid syndrome (PAPS) were retrospectively enrolled in the study. Administration of Hydroxychloroquine (HCQ) daily, in addition to conventional therapy (prophylactic or therapeutic doses of heparin and low-dose aspirin), in patients with primary antiphospholipid syndrome (PAPS). exposed to other treatment, sick
Administration of low dose steroid, in addition to conventional therapy (prophylactic or therapeutic doses of heparin and low-dose aspirin), in patients with primary antiphospholipid syndrome (PAPS).
94 / 36
Sciascia, 2016 United Kingdom
2008 - 2014
All the pregnancies in women with persisting antiphospholipid antibodies (aPL). Pregnancies in women with antiphospholipid antibodies (aPL) treated with hydroxychloroquine (HCQ) for at least 6 months prior to pregnancy and continued throughout gestation. unexposed, sick
Pregnancies in women with antiphospholipid antibodies (aPL) not treated with hydroxychloroquine (HCQ) during pregnancy.
51 / 119 In 26 pregnancies women received HCQ 200 mg twice daily, and in 25 pregnancies women received HCQ 200 mg once daily.
Ye, 2017 China
2011- 2016
Recurrent spontaneous abortion (RSA) patients with Antiphospholipid syndrome (APS) who underwent regular prenatal examinations and delivered at Peking University Third Hospital. Prednisone (10 mg/d), Hydroxychloroquine (0.2 g bid), Low‐dose aspirin (75 mg/d) taken from the 6th day of the menstrual cycle, then injection of low‐molecular‐weight heparin (5000 U/d). Prednisone, LDA and LMWH stopped at 14 ; 36 gestational weeks and 24 h before delivery, respectively. unexposed, sick
Low‐dose aspirin (LDA) and low‐molecular‐weight heparin (LMWH) combination therapy taken with the same usage as former.
126 / 141

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk
Lockshin, 2012 USA (Seven study sites recruited)
2003 - 2011
Patients who had any Adverse pregnancy outcomes (APOs), defined as an otherwise unexplained fetal demise after 12 weeks, neonatal death prior to discharge, associated with complications of prematurity, preterm delivery prior to 34 weeks because of gestational hypertension, preeclampsia or placental insufficiency, and small for gestational age (birth weight <5th percentile). Patients who had not Adverse pregnancy outcomes (APOs). 28 / 116 Control group: sick and healthy. Indications: SLE (n=174); antiphospholipid antibody (aPL; n=87); aPL and SLE (n=57). => analyses performed on 144 patients with aPL.
Yelnik, 2016 USA, Canada, United Kingdom
2011 - 2015
Patients who had any Adverse pregnancy outcomes (APOs), defined as: fetal death after 12 weeks of gestation, neonatal death before hospital discharge due to complications of prematurity, preterm delivery before 36 weeks of gestation due to gestational hypertension, pre-eclampsia or placental insufficiency and small-for- gestational-age (SGA) neonate (birth weight, fifth percentile). Patients who had not Adverse pregnancy outcomes (APOs). 13 / 31

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