{"title":"Hydroxychloroquine and pregnancy outcomes in patients with anti-phospholipid syndrome: a systematic review and meta-analysis.","authors":"Aya Berman, Gili Kenet, Aharon Lubetsky, Nancy Agmon-Levin, Shelly Soffer, Assaf A Barg, Sarina Levy-Mendelovich, Omri Cohen, Liat Waldman-Radinsky, Shadan Lalezari, Eyal Klang, Orly Efros","doi":"10.1136/rmdopen-2025-005825","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>To evaluate the impact of HCQ on live birth and obstetric complication rates in pregnant women diagnosed with APS.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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>I</i> <sup>2</sup>=81%) and 73.9% (95% CI 51.8% to 88.2%; <i>I</i> <sup>2</sup>=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>I</i> <sup>2</sup>=81%; four studies) of the HCQ group and 55.0% (95% CI 39.4 to 69.7; <i>I</i> <sup>2</sup>=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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Prospero registration number: </strong>The study was registered with PROSPERO, the prospective international register of systematic reviews (identification number CRD42024574097).</p>","PeriodicalId":21396,"journal":{"name":"RMD Open","volume":"11 3","pages":""},"PeriodicalIF":4.7000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12410631/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"RMD Open","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/rmdopen-2025-005825","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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%; I2=81%) and 73.9% (95% CI 51.8% to 88.2%; I2=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; I2=81%; four studies) of the HCQ group and 55.0% (95% CI 39.4 to 69.7; I2=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).
背景:约20%的抗磷脂综合征(APS)女性患者尽管接受阿司匹林和肝素的标准治疗,但仍会出现产科并发症。羟基氯喹(HCQ)治疗可减少系统性红斑狼疮患者妊娠期间的疾病发作,并改善妊娠结局。目的:评价HCQ对APS孕妇活产率和产科并发症发生率的影响。方法:我们于2024年4月系统检索PubMed和EMBASE数据库,检索有关HCQ对APS患者疗效和安全性的原始同行评审研究。测量的主要结果是活产和产科并发症,比较HCQ加标准治疗和单独标准治疗。结果:7项观察性研究符合我们的纳入标准,meta分析共纳入750例患者。HCQ组的总总活产比例为89.9% (95% CI 76.5% ~ 96.0%; i2 =81%),非HCQ治疗组的总总活产比例为73.9% (95% CI 51.8% ~ 88.2%; i2 =81%)。产科并发症的总合并比例在HCQ组为19.3% (95% CI 9.4% ~ 35.4; I 2=81%; 4项研究),在非HCQ治疗组为55.0% (95% CI 39.4 ~ 69.7; I 2=79%; 4项研究)。与非HCQ治疗相比,HCQ治疗与更高的活产率(OR 2.66; 95% CI 1.44至4.91)和更低的产科并发症(OR 0.19; 95% CI 0.19至0.39)相关。妊娠期HCQ治疗耐受性良好。结论:我们的研究结果表明,HCQ可能通过增加活产率和降低产科并发症的风险,为妊娠期APS患者提供潜在的益处。普洛斯彼罗注册号:本研究已在普洛斯彼罗注册,普洛斯彼罗是国际前瞻性系统评价注册库(识别号CRD42024574097)。
期刊介绍:
RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.