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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The three included studies were a randomized prospective trial in Greece, a retrospective multicenter propensity score-matched cohort in Italy, and a prospective non-randomized controlled study in France.
“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]
Three clinical studies met inclusion criteria, comprising 164 adult patients with thrombotic primary antiphospholipid syndrome, of whom 82 received hydroxychloroquine and 82 received standard therapy alone.
“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 Kravvariti et al., in multivariable Cox regression adjusting for cardiovascular risk factors, prior recurrences, antiphospholipid antibody profile, and quality of anticoagulation control, hydroxychloroquine use was associated with a hazard ratio of 0.09 (95% CI 0.01-1.26).
“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]
Across included studies, patients were predominantly female (approximately 70-80% when reported) and all had a documented history of objectively confirmed thrombosis fulfilling APS classification criteria.
“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 Kravvariti et al., 50 patients with thrombotic primary antiphospholipid syndrome were randomized to hydroxychloroquine plus standard antithrombotic therapy (n=25) or standard therapy alone (n=25) and followed for a mean of 2.6 years.
“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]
High-risk antiphospholipid antibody profiles (lupus anticoagulant positivity and/or double antiphospholipid antibody positivity) were frequent, although reporting of triple positivity was heterogeneous.
“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]
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.
“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 Kravvariti et al., recurrent thrombotic events occurred far less frequently in the hydroxychloroquine group, with an incidence rate of 0.001 events per patient-year versus 0.007 events per patient-year in controls, representing an approximate 86% relative reduction.
“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]
The absence of a bleeding signal attributable to hydroxychloroquine in any of the included studies supports its favorable risk-benefit profile.
“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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Self-citationRuiz‐Irastorza, G., Tektonidou, M. G., & Khamashta, M. A. (2024) · Lara D. Veeken · doi:10.1093/rheumatology/kead538 · Cited by 20 · see citing works
Self-citationBiologic Functions of Hydroxychloroquine in Disease: From COVID-19 to Cancer
Niemann, B. R., Puleo, A., Stout, C., Markel, J., & Boone, B. A. (2022) · Pharmaceutics · doi:10.3390/pharmaceutics14122551 · Cited by 19 · see citing works
Towards precision medicine in antiphospholipid syndrome
López-Pedrera, C., Pérez-Sánchez, C., & Tektonidou, M. G. (2025) · The Lancet Rheumatology · doi:10.1016/s2665-9913(25)00094-3 · Cited by 16 · see citing works
Self-citationBelimumab reduces antiphospholipid antibodies in primary triple-positive antiphospholipid syndrome
Klemm, P., Müller‐Ladner, U., Tarner, I. H., et al. (2020) · Autoimmunity Reviews · doi:10.1016/j.autrev.2020.102594 · Cited by 16 · see citing works
Emerging Therapies in Antiphospholipid Syndrome
Hubben, A. K., & McCrae, K. R. (2022) · Transfusion Medicine Reviews · doi:10.1016/j.tmrv.2022.09.002 · Cited by 15 · see citing works
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“This study also revealed that long-term HCQ was associated with a reduction in all aPL titres except IgM aCL [77].”
BackgroundBarilaro, G., Esteves, A., Rocca, C. D., Pérez-Isidro, A., Araújo, O., da Rosa, G. P., Ruiz‐Ortiz, E., Penella, D. T., Viñas, O., Reverter, J. C., et al. (2022) · Rheumatology · doi:10.1093/rheumatology/keac485 · Cited by 14 · see citing works
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“(Kravvariti et al., 2020) reported the results of a randomized controlled study, which suggested that HCQ could also reduce the incidence of thrombosis and lower APL titers in APS patients.”
Sadr, M. S., Heydarinasab, A., Panahi, H. A., et al. (2020) · Polymers for Advanced Technologies · doi:10.1002/pat.5110 · Cited by 13 · see citing works
Ugarte, A., de Bustos, A. G., Ruiz‐Arruza, I., Soto-Peleteiro, A., Martín‐Iglesias, D., González-Echávarri, C., & Ruiz‐Irastorza, G. (2021) · Rheumatology · doi:10.1093/rheumatology/keab307 · Cited by 13 · see citing works
Barilaro, G., Coloma, E., Chacur, C. A., Rocca, C. D., Pérez-Isidro, A., Ruiz‐Ortiz, E., Viñas, O., Penella, D. T., Reverter, J. C., Andújar, A. M., et al. (2022) · Autoimmunity Reviews · doi:10.1016/j.autrev.2022.103208 · Cited by 13 · see citing works
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“24 Zhou et al conducted an additional comparative analysis of the live birth rate in primary APS and secondary APS (SLE-APS; SAPS) patients treated with HCQ.”
Xie, W., Ji, L., & Zhang, Z. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.857424 · Cited by 12 · see citing works
Deciphering the clinical significance of longitudinal antiphospholipid antibody titers
Chighizola, C. B., Willis, R., Maioli, G., Sciascia, S., Andréoli, L., Amengual, O., Radin, M., Gerosa, M., Atsumi, T., de Jesús, G. R., et al. (2024) · Autoimmunity Reviews · doi:10.1016/j.autrev.2023.103510 · Cited by 15 · see citing works
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Update on antiphospholipid syndrome
Tektonidou, M. G. (2024) · Lara D. Veeken · doi:10.1093/rheumatology/kead633 · Cited by 12 · see citing works
Self-citationCecchi, I., Radin, M., Foddai, S. G., Barinotti, A., ANDRADE, D. C. O. D., Tektonidou, M. G., Pengo, V., Ruiz‐Irastorza, G., Belmont, M. H., López-Pedrera, C., et al. (2024) · Lara D. Veeken · doi:10.1093/rheumatology/keae583 · Cited by 11 · see citing works
Self-citationNeurologic Manifestations of Catastrophic Antiphospholipid Syndrome
Mustafa, R. (2022) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-022-01228-0 · Cited by 10 · see citing works
Nasonov, E. L. (2024) · Rheumatology Science and Practice · doi:10.47360/1995-4484-2024-32-54 · Cited by 12 · see citing works
Cardiovascular disease and antiphospholipid syndrome: how to predict and how to treat?
Calcaterra, I. L., Tufano, A., Lupoli, R., Iannuzzo, G., Emmi, G., & Minno, M. N. D. D. (2020) · Polskie Archiwum Medycyny Wewnętrznej · doi:10.20452/pamw.15415 · Cited by 12 · see citing works
Scoping insight on antiviral drugs against COVID-19
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Liu, M., Li, G., Song, X., Fan, Y., & Li, C. (2023) · Scientific Reports · doi:10.1038/s41598-023-35955-2 · Cited by 10 · see citing works
Botelho, M. S., Bolfi, F., Leite, R. G. O. F., Leite, M. S. F., Banzato, L. R., Soares, L. T., Olivatti, T. O. F., Mangolim, A. S., Oliveira, F. R. K., Abbade, L. P. F., et al. (2021) · Systematic Reviews · doi:10.1186/s13643-021-01835-x · Cited by 9 · see citing works
Can hydroxychloroquine be protective against COVID-19-associated thrombotic events ?
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New frontiers in rheumatoid arthritis therapy: From classic DMARDs to biologics and beyond
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Risk Assessment and Antithrombotic Strategies in Antiphospholipid Antibody Carriers
Calcaterra, I. L., Ambrosino, P., Vitelli, N., Lupoli, R., Orsini, R. C., Chiurazzi, M., Maniscalco, M., & Minno, M. N. D. D. (2021) · Biomedicines · doi:10.3390/biomedicines9020122 · Cited by 8 · see citing works
“The study also showed that long-term HCQ is associated with a decrease in all aPL titers, except for IgM aCL [73].”
BackgroundNavigating antiphospholipid syndrome: from personalized therapies to cutting-edge research
Kortright‐Maldonado, K., Reyes‐Torres, B. E., Cabrera-Lopez, L. S., et al. (2024) · Rheumatology Advances in Practice · doi:10.1093/rap/rkaf005 · Cited by 7 · see citing works
“Their study also showed that HCQ might reduce vascular inflammation by modulating Toll-like receptor pathways and inhibiting platelet aggregation [46].”
Antiphospholipid antibodies and atherosclerotic vascular disease: recent advances
Undas, A., Musiał, J., & Ząbczyk, M. (2025) · Rheumatology International · doi:10.1007/s00296-025-06050-8 · Cited by 7 · see citing works
“APS is not a contraindication for PCSK9 inhibitors and should be used if a target LDL cholesterol 1 3 Hydroxychloroquine This common disease-modifying antirheumatic drug exerts anti-inflammatory and cardioprotective actions [ 99, 100].”
Coronavirus-disease-2019-induced antiphospholipid-like syndrome: a case report
Bahramnezhad, F., Ghorbani, B., Ghaedrahamt, M., & Jamaati, H. (2021) · Journal of Medical Case Reports · doi:10.1186/s13256-021-02966-4 · Cited by 7 · see citing works
“It has been recommended to reexamine the patient at least two times in 12 weeks to confirm this diagnosis [9, 10].”
BackgroundTherapeutic Drug Monitoring in Patients with Systemic Lupus Erythematosus: Utility and Gaps
Chong, K. M., Jiang, H., Lo, E. A. G., et al. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13020451 · Cited by 7 · see citing works
“…survival [5], reduces the risk of all flares [6] and renal flares [7], improves the response to induction therapies in lupus nephritis [5], retards irreversible organ damage [8], especially cardiovascular damage, and reduces thrombosis in patients with associated antiphospholipid syndrome [9].”
BackgroundBarros Edington, F. L., de Rezende, D. F., dos Santos, L. F. S., Garcia, R. V., Gadelha, S. R., & Santiago, M. B. (2022) · Lupus · doi:10.1177/09612033221074192 · Cited by 7 · see citing works
“One hospital, though, obtained approval to continue the study as a singlecenter and published their results in 2020.(8) The authors found that hydroxychloroquine use was associated with an 85% reduction in the incidence rate of thrombosis, which until the date this manuscript was written, was the last RCT to primarily…”
ResultBucci, T., Menichelli, D., Palumbo, I., Pastori, D., Ames, P. R. J., Lip, G. Y. H., & Pignatelli, P. (2025) · Cells · doi:10.3390/cells14050353 · Cited by 6 · see citing works
“After a mean follow-up of 2.6 years, the authors found a significant reduced risk of thrombosis in HCQ users even after adjusting for confounders (HR of 0.09, 95% CI of 0.01–1.26) [87 ].”
InfluentialShen, J., Tao, Z., Chen, W., et al. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.882032 · Cited by 6 · see citing works
Barilaro, G., Rocca, C. D., Esteves, A., Cervera, R., & Espinosa, G. (2022) · Rheumatology · doi:10.1093/rheumatology/keac619 · Cited by 6 · see citing works
Revisiting antiphospholipid syndrome: A thrombo-inflammatory disorder beyond clotting
Ducker, C. B., Preece, M. V., Pericleous, C., et al. (2026) · Blood Reviews · doi:10.1016/j.blre.2026.101364 · Cited by 5 · see citing works
Antiphospholipid antibodies as potential prognostic indicators of recurrent ischemic stroke
Geng, L., Pan, K., Xu, Y., Zhang, B., Wang, J., Xue, Q., Zhang, S., Su, H., & Zhang, B. (2024) · Journal of Stroke and Cerebrovascular Diseases · doi:10.1016/j.jstrokecerebrovasdis.2024.107885 · Cited by 7 · see citing works
Precision medicine as an approach to autoimmune diseases
Fritzler, M. J., & Mähler, M. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-820239-5.00007-3 · Cited by 5 · see citing works
Aljubailah, A., Alharbi, W. N. O., Haidyrah, A. S., et al. (2021) · Polymers · doi:10.3390/polym13234072 · Cited by 5 · see citing works
“This medication is an antimalarial widely used in the treatment of systemic lupus erythematosus, rheumatoid arthritis, malaria and other autoimmune diseases [1,2].”
Thrombotic antiphospholipid syndrome: From guidelines to clinical management
Paredes, D., Martín‐Iglesias, D., & Ruiz‐Irastorza, G. (2024) · Medicina Clínica · doi:10.1016/j.medcli.2024.02.010 · Cited by 5 · see citing works
Unresolved issues in the diagnosis and management of thrombotic antiphospholipid syndrome
Arachchillage, D. J., & Laffan, M. (2025) · Research and Practice in Thrombosis and Haemostasis · doi:10.1016/j.rpth.2025.102724 · Cited by 6 · see citing works
“In another small study that included 50 patients with APS, the use of HCQ as an adjunct treatment with anticoagulation achieved a lower risk of thrombosis at 2.6 years (0.001 vs 0.007; log-rank P = .048) [46].”
InfluentialPerrella, A., Orlando, V., Trama, U., et al. (2021) · Viruses · doi:10.3390/v13102052 · Cited by 4 · see citing works
“Particularly the reduction was associated to the increase of the dosage of hydroxychloroquine [14,15].”
BackgroundHuang, Y., Liu, H., Qi, W., Dû, L. T. H., Li, M., Zeng, X., Guo, X., Zhao, J., & Zhang, S. (2022) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2022.895098 · Cited by 4 · see citing works
Endothelial dysfunction in APS: advancing pathophysiological understanding to improve management
Pericleous, C., Strauss, E., & Arachchillage, D. J. (2026) · Current Opinion in Immunology · doi:10.1016/j.coi.2026.102745 · Cited by 3 · see citing works
Chatzidionysiou, K., Samoli, E., Sfikakis, P. P., & Tektonidou, M. G. (2020) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2020-218444 · Cited by 3 · see citing works
Self-citationMedications, Therapeutic Modalities, and Regimens Used in the Management of Rheumatic Diseases
Moutsopoulos, H. Μ., & Zampeli, E. (2020) · Springer eBooks · doi:10.1007/978-3-030-56670-8_14 · Cited by 3 · see citing works
Early HELLP Syndrome or Catastrophic Antiphospholipid Syndrome? A Diagnostic Dilemma
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“However, a recent randomized prospective study shows promise with a reduction in thrombotic events and no statistically significant differences in safety outcomes [18].”
BackgroundWhat are the prospects for antiplatelet agents for thromboprophylaxis in antiphospholipid syndrome?
Ruiz‐Irastorza, G., & Khamashta, M. A. (2022) · Expert Review of Clinical Immunology · doi:10.1080/1744666x.2022.2090338 · Cited by 3 · see citing works
“cohort [24] and also in patients with primary APS [25].”
BackgroundAntiphospholipid Syndrome and the Kidney
Taghavi, M., Jacobs, L., Roccatello, D., et al. (2025) · Kidney International Reports · doi:10.1016/j.ekir.2025.09.010 · Cited by 2 · see citing works
“65-68 Some other potential targeted treatments are currently under evaluation in APS, without evaluation on aPLN outcome.”
Očková, M., Anunciación-Llunell, A., Andrada, C., Esteve‐Valverde, E., Miró‐Mur, F., & Alijotas‐Reig, J. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14207164 · Cited by 2 · see citing works
“In a recent study, heparin could lower a β 2 GPI-IgM levels while keeping aCL-IgM levels unaffected, but the molecular mechanism remains unknown [85].”
aPLs seroconversion in antiphospholipid syndrome: from definition to clinical relevance
Giorgio, A. D., Carnuccio, C., Nesci, A., Stefano, V. D., & Santoliquido, A. (2026) · Thrombosis Research · doi:10.1016/j.thromres.2026.109622 · Cited by 2 · see citing works
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Hou, X., Chang, R., Wang, Y., Kang, T., & Wei, J. C. (2024) · International Journal of Rheumatic Diseases · doi:10.1111/1756-185x.15102 · Cited by 2 · see citing works
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Should coronavirus disease 2019 concern rheumatologists?
Kucharz, E. J. (2020) · Polskie Archiwum Medycyny Wewnętrznej · doi:10.20452/pamw.15366 · Cited by 2 · see citing works
Is Hydroxychloroquine having arole for Prevention of Unexplained Recurrent Miscarriage?
Sayed, A. H. E., Mohamed, A. R., & Sekkean, I. A. (2022) · Al-Azhar International Medical Journal /Al-Azhar International Medical Journal · doi:10.21608/aimj.2022.125300.1870 · Cited by 2 · see citing works
Update on Stroke Prevention and Treatment in Patients with Antiphospholipid Antibody Syndrome
Xeros, H. K., Bates, M. C., & Mustafa, R. (2025) · Current Treatment Options in Neurology · doi:10.1007/s11940-025-00828-8 · Cited by 1 · see citing works
“…an open-label, randomized controlled trial indicated that patients receiving hydroxychloroquine in conjunction with standard care experienced lower rates of thrombosis compared to those receiving standard care alone, both in APS patients and in asymptomatic individuals who were aPL-positive [66].”
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Catastrophic antiphospholipid syndrome: A prototype of autoimmune thromboinflammation
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Hydroxychloroquine dans les maladies systémiques et auto-immunes : où en sommes-nous ?
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Antiphospholipid Syndrome and Stroke
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Anticardiolipin Antibodies in COVID-19 – Report of Three Cases
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The place of hydroxychloroquine in modern dermatology
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- 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
- 112
- References
- 43
- Citations by year
- 2026: 10 · 2025: 13 · 2024: 15 · 2023: 12 · 2022: 22 · 2021: 20 · 2020: 19
- FWCI
- 11.79
- 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 › Surgery › 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
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