Hydroxychloroquine and pregnancy outcomes in patients with anti-phospholipid syndrome: a systematic review and meta-analysis.

Background: About 20% of female patients with anti-phospholipid syndrome (APS) experience obstetric complications despite standard treatment with aspirin and heparin. Treatment with hydroxychloroquine (HCQ) was shown to reduce disease flares during pregnancy in patients with systemic lupus erythematosus and to improve pregnancy outcomes.

Objectives: To evaluate the impact of HCQ on live birth and obstetric complication rates in pregnant women diagnosed with APS.

Methods: We systematically searched PubMed and EMBASE databases in April 2024 for original, peer-reviewed studies on HCQ efficacy and safety in APS patients. The main outcomes measured were live births and obstetric complications, comparing HCQ plus standard therapy to standard therapy alone.

Results: Seven observational studies met our inclusion criteria, comprising a total of 750 patients included in the meta-analysis. The overall pooled proportions of live births in the HCQ group were 89.9% (95% CI 76.5% to 96.0%; I ²=81%) and 73.9% (95% CI 51.8% to 88.2%; I ²=81%) in the non-HCQ-treated group. The overall pooled proportion of obstetric complications occurred in 19.3% (95% CI 9.4% to 35.4; I ²=81%; four studies) of the HCQ group and 55.0% (95% CI 39.4 to 69.7; I ²=79%; four studies) of the non-HCQ treated group. Treatment with HCQ was associated with higher rates of live births (OR 2.66; 95% CI 1.44 to 4.91) and lower obstetric complications (OR 0.19; 95% CI 0.19 to 0.39) compared with non-HCQ treatment. HCQ treatment during pregnancy was well tolerated.

Conclusions: Our findings suggest that HCQ may offer potential benefits to APS patients during pregnancy by increasing the probability of live birth rates and lowering the risk for obstetric complications.

Prospero registration number: The study was registered with PROSPERO, the prospective international register of systematic reviews (identification number CRD42024574097).