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The effect of hydroxychloroquine on thrombosis prevention and antiphospholipid antibody levels in primary antiphospholipid syndrome: A pilot open label randomized prospective study
Abstract
BACKGROUND Sporadic studies suggest hydroxychloroquine (HCQ) may be effective in thrombosis prevention in patients with primary antiphospholipid syndrome (PAPS) and may lead to antiphospholipid antibody titers (aPL) reduction but data from randomized studies are lacking. METHODS We conducted a pilot open-label randomized prospective study aiming to evaluate the safety and efficacy of HCQ for thrombosis prevention in 50 patients with PAPS allocated 1:1 to HCQ plus standard care (systemic anticoagulation and/or antiplatelet therapy) vs. standard care alone, as well as the effect of HCQ on aPL titers of 50 PAPS patients and 15 asymptomatic aPL carriers. RESULTS HCQ use plus standard care was associated with lower incidence rate of thrombosis than standard care alone (0.001 vs. 0.007, log-rank p = .048) over an average 2.6-year follow-up, and a multivariate hazard ratio of 0.09 (95% CI = 0.01-1.26, p = .074) after adjusting for the effect of age, sex, traditional cardiovascular risk factors, triple aPL positivity, history of recurrent thrombotic events at baseline, and poor anticoagulation quality (INR levels within therapeutic range for ≤80% of follow-up). No significant difference in safety outcomes was observed between the two groups. Long-term HCQ use was associated with a decrease in aPL titers except for IgM anticardiolipin antibodies, which tended to decrease overtime regardless of treatment allocation. CONCLUSIONS HCQ may represent an effective adjuvant treatment for thrombosis prevention in patients with PAPS, which may be mediated via a reduction in aPL titers. Larger randomized trials are needed in order to corroborate this finding and investigate the thromboprotective role of HCQ in asymptomatic aPL carriers.
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In the citing paper
“One study was a randomized prospective trial conducted in Greece [8], one a retrospective multicenter propensity score-matched cohort from Italy [9], and one a prospective non-randomized controlled study from France [10].”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
In the citing paper
“Three clinical studies met the inclusion criteria, comprising a total of 164 adult patients with thrombotic primary antiphospholipid syndrome (PAPS), of whom 82 received hydroxychloroquine (HCQ) in addition to standard antithrombotic therapy and 82 received standard therapy alone [8–10].”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
In the citing paper
“In multivariable Cox regression analysis adjusting for cardiovascular risk factors, prior recurrences, antiphospholipid antibody profile, and quality of anticoagulation control, HCQ use was associated with a hazard ratio (HR) of 0.09 (95% CI 0.01–1.26), reflecting a strong protective signal despite limited statistical power [8].”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
In the citing paper
“Across studies, patients were predominantly female (approximately 70–80% women, when reported), and all had a documented history of objectively confirmed thrombosis fulfilling APS classification criteria.”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
In the citing paper
“In the open-label randomized prospective trial by Kravvariti et al., 50 patients with thrombotic PAPS were randomized to receive HCQ plus standard antithrombotic therapy (n = 25) or standard therapy alone (n = 25) and followed for a mean of 2.6 years [8].”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
In the citing paper
“High-risk antiphospholipid antibody profiles (lupus anticoagulant positivity and/or double aPL positivity) were frequent, although reporting of triple positivity was heterogeneous [8–10].”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
In the citing paper
“The majority of patients had experienced venous thromboembolism as the index event, while arterial thrombosis accounted for a smaller but clinically relevant proportion of cases.”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
In the citing paper
“Recurrent thrombotic events occurred far less frequently in the HCQ group, with an incidence rate of 0.001 events per patient-year, compared with 0.007 events per patient-year in controls. This represents an approximate 86% relative reduction in thrombotic recurrence.”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
In the citing paper
“The absence of a bleeding signal attributable to HCQ in any of the included studies further supports its favorable risk–benefit profile [8–10].”
From Hydroxychloroquine as an Adjunct Therapy for Secondary Thrombosis Prevention in Primary Antiphospholipid Syndrome: A Systematic Review and Meta-analysis (2026) · cites this paper as [8]
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Metadata
- Authors
- Kravvariti, E., Koutsogianni, A., Samoli, E., Sfikakis, P. P., & Tektonidou, M. G.
- Affiliations
- National and Kapodistrian University of Athens (GR)
- Corresponding author
- Tektonidou, Maria G.
- ORCID
- Venue
- Autoimmunity Reviews
- Publisher
- Elsevier BV
- Published
- 2020-04
- Volume
- 19
- Issue
- 4
- Pages
- 102491
- ISSN
- 1568-9972 (ISSN-L)
- OpenAlex
- W3008510500
- Semantic Scholar
- d74efcd098cf5d0bbdeaaac4fe85dd4a0f24befe
- Cited by
- 115
- References
- 43
- Citations by year
- 2026: 12 · 2025: 15 · 2024: 15 · 2023: 12 · 2022: 22 · 2021: 20 · 2020: 19
- FWCI
- 11.60
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Autoimmunity Reviews (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National and Kapodistrian University of Athens (11123)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Hematology › Heparin-Induced Thrombocytopenia and Thrombosis
- Keywords
- hydroxychloroquine, primary antiphospholipid syndrome, thromboprophylaxis, antiphospholipid antibodies, anticardiolipin antibodies, anticoagulation, antiplatelet therapy, drug safety
- MeSH terms
- Adult, Anticoagulants, Female, Humans, Hydroxychloroquine, Male, Middle Aged, Pilot Projects, Thrombosis, Antiphospholipid Syndrome, Antibodies, Antiphospholipid
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