The impact of hydroxychloroquine treatment on pregnancy outcome in women with antiphospholipid antibodies

Abstract

BACKGROUND:Antiphospholipid syndrome is defined by the combination of thrombotic events and/or obstetric morbidity in patients who have tested positive persistently for antiphospholipid antibodies. With good treatment, approximately 70% of pregnant women with antiphospholipid syndrome will deliver a viable live infant. However, current management does not prevent all maternal, fetal, and neonatal complications of antiphospholipidsyndrome. OBJECTIVES:This observational, retrospective, single-center cohort study aimed to assess pregnancy outcomein women with antiphospholipid antibodies who were treated with hydroxychloroquine in addition to conventionaltreatment during pregnancy. STUDY DESIGN:One-hundred seventy pregnancies in 96 women with persistent antiphospholipid antibodies were analyzed: (1) 51 pregnancies that occurred in 31 women were treated with hydroxychloroquine for at least 6 months before pregnancy, and the therapy continued throughout gestation (group A); (2) 119 pregnancies that occurred in 65 women with antiphospholipid antibodies that were not treated with hydroxychloroquine were included as controls (group B). RESULTS:Hydroxychloroquine-treatment was associated with a higher rate of live births (67% group A vs 57% group B; P = .05) and a lower prevalence of antiphospholipid antibodiesrelated pregnancy morbidity (47% group A vs 63% B; P = .004). The association of hydroxychloroquine with a lower rate of any complication in pregnancywas confirmed after multivariate analysis (odds ratio, 2.2; 95% confidence interval, 1.2-136; P = .04). Fetal losses at >10 weeks of gestation (2% vs 11%; P = .05) and placenta-mediated complications (2% vs 11%; P = .05) were less frequent in group A than group B. Pregnancy duration was longer in group A than group B (27.6 [6-40] vs 21.5 [6-40] weeks; P = .03). There was a higher rate of spontaneous vaginal labor in hydroxychloroquine-treatedwomen compared with group B (37.3% vs 14.3%; P = .01). CONCLUSIONS:Despite the heterogeneity in the 2 groups in terms of systemic lupus erythematosus prevalence and previous pregnancy history, our results support the concept that women with antiphospholipid antibodies may benefit from treatment with hydroxychloroquine during pregnancy to improve pregnancy outcome. The addition ofhydroxychloroquine to conventional treatment is worthy of further assessment in a proper designed randomized controlled trial.

A comprehensive review of the clinical approach to pregnancy and systemic lupus erythematosus

“…The use of HCQ was recently associated with a higher rate of live births and a lower frequency of overall aPL-related pregnancy complication [130]. Retrospective observational clinical data, also supported the positive effects of HCQ during pregnancy in aPL women in a recent European multicentre study [131].…”

EULAR recommendations for women's health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome

“…111 117 118 Adjunct treatment during pregnancy Use of HCQ is recommended in women with SLE preconceptionally and throughout pregnancy. 33 56 60 A beneficial role has also been suggested for APS pregnancies, [119][120][121] but at present there is insufficient data to recommend its routine use in these patients. HCQ may reduce the odds of CHB occurrence in fetuses exposed to maternal anti-Ro/SSA antibodies, especially in mothers who already had a child with CHB.…”

Diagnosis and management of the antiphospholipid syndrome

“…179 A retrospective cohort study of pregnant women with APLA reported marginally higher rates of live births (67% versus 57%; P = .05) and a lower prevalence of APLA-related pregnancy morbidity (47% versus 63%; P = .004) in women who received hydroxychloroquine for 6 months prior to and continued throughout pregnancy. 180 Hydroxychloroquine is advised for APLA positive patients with SLE; however, there is currently no high quality that supports the use of hydroxychloroquine in patients with primary APS. Unfortunately, a multicenter, randomized trial of hydroxychloroquine for primary thrombosis prevention in patients with primary APS (clinicaltrials.gov #NCT01784523) was terminated due to poor accrual.…”