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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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“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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“However, hydroxychloroquine use itself has also been associated with a reduction in aPL in patients with primary APS [73], which may thus constitute a confounding factor.”
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“The study also showed that long-term HCQ is associated with a decrease in all aPL titers, except for IgM aCL [73].”
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Kortright‐Maldonado, K., Reyes‐Torres, B. E., Cabrera-Lopez, L. S., Rodríguez‐Henríquez, P., Tenorio-Aguirre, E. K., & Martínez‐Sánchez, F. D. (2024) · Rheumatology Advances in Practice · doi:10.1093/rap/rkaf005 · Cited by 7
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“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
“…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
“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 8
“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
Barilaro, G., Rocca, C. D., Esteves, A., Cervera, R., & Espinosa, G. (2022) · Rheumatology · doi:10.1093/rheumatology/keac619 · Cited by 6
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
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
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
Aljubailah, A., Alharbi, W. N. O., Haidyrah, A. S., et al. (2021) · Polymers · doi:10.3390/polym13234072 · Cited by 5
“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 6
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 8
“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
“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
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
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
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
Early HELLP Syndrome or Catastrophic Antiphospholipid Syndrome? A Diagnostic Dilemma
Bae, S., Comfort, L., Ng, J., et al. (2023) · Cureus · doi:10.7759/cureus.38244 · Cited by 3
“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
“cohort [24] and also in patients with primary APS [25].”
BackgroundAntiphospholipid Syndrome and the Kidney
Taghavi, M., Jacobs, L., Roccatello, D., & Sciascia, S. (2025) · Kidney International Reports · doi:10.1016/j.ekir.2025.09.010 · Cited by 3
“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
“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
Sciascia, S., Foddai, S. G., Alessandri, C., Alunno, A., Andréoli, L., Barinotti, A., Calligaro, A., Canti, V., Carubbi, F., Cecchi, I., et al. (2022) · Thrombosis and Haemostasis · doi:10.1055/a-1798-2400 · Cited by 2
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
Matys, V., Rizzo, F., Carolis, M. P. D., et al. (2025) · Frontiers in Lupus · doi:10.3389/flupu.2025.1480867 · Cited by 2
Should coronavirus disease 2019 concern rheumatologists?
Kucharz, E. J. (2020) · Polskie Archiwum Medycyny Wewnętrznej · doi:10.20452/pamw.15366 · Cited by 2
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
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
“…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].”
Tektonidou, M. G., Cervera, R., Tincani, A., Pons‐Estel, G., Sciascia, S., Stamm, T., Landewé, R., & Ward, M. M. (2025) · EULAR Rheumatology Open · doi:10.1016/j.ero.2025.07.009 · Cited by 1
Self-citationEvolution of therapy for autoimmune diseases in pregnancy: a retrospective study from 2000 to 2023
Garufi, C., Rizzo, F., Matys, V., Garufi, E., Botta, A., Andreozzi, V., Salvi, S., Ghi, T., & Carolis, S. D. (2026) · Frontiers in Medicine · doi:10.3389/fmed.2026.1716385 · Cited by 2
Catastrophic antiphospholipid syndrome: A prototype of autoimmune thromboinflammation
Nasonov, E. L., Reshetnyak, T. M., Клименко, А. А., & Nikolaeva, E. V. (2026) · Rheumatology Science and Practice · doi:10.47360/1995-4484-2026-227-248 · Cited by 2
Hydroxychloroquine dans les maladies systémiques et auto-immunes : où en sommes-nous ?
Dima, A., Jurcuț, C., & Arnaud, L. (2021) · Revue du Rhumatisme · doi:10.1016/j.rhum.2021.05.002 · Cited by 1
Antiphospholipid Syndrome and Stroke
Grimes, K., Klein, A. P., Lalla, R., Morawo, A., Somani, S., Woodward, M. J., & Cole, J. W. (2022) · IntechOpen eBooks · doi:10.5772/intechopen.101777 · Cited by 2
Anticardiolipin Antibodies in COVID-19 – Report of Three Cases
Dima, A., Moroti, R., Popescu, D. N., et al. (2021) · Internal Medicine · doi:10.2478/inmed-2021-0151 · Cited by 1
de Carvalho, J. F., Hautz, E., & Cervera, R. (2026) · Rheumatology and Therapy · doi:10.1007/s40744-026-00858-x · Cited by 3
Bose, D., Konwar, M., Maurya, M. R., et al. (2021) · Current Clinical Pharmacology · doi:10.2174/1574884716666210726104424
The place of hydroxychloroquine in modern dermatology
Dańczak‐Pazdrowska, A., & Polańska, A. (2021) · Dermatology Review · doi:10.5114/dr.2021.108614
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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