TY - JOUR
T1 - Clinical and biologic predictors of thrombosis in persistently antiphospholipid antibody-positive patients
T2 - Prospective analysis of the International APS ACTION Clinical Database and Repository (‘Registry’)
AU - Thaler, Jonathan
AU - Parides, Michael
AU - de Andrade, Danieli Castro Oliveira
AU - Ruiz, Diana Paredes
AU - Tektonidou, Maria G.
AU - Pengo, Vittorio
AU - Sciascia, Savino
AU - Nalli, Cecilia
AU - de Jesús, Guilherme
AU - Fortin, Paul R.
AU - Efthymiou, Maria
AU - Belmont, H. Michael
AU - Petri, Michelle
AU - Cervera, Ricard
AU - Skeith, Leslie
AU - Atsumi, Tatsuya
AU - López-Pedrera, Chary
AU - Zuo, Yu
AU - Branch, D. Ware
AU - Willis, Rohan
AU - Kello, Nina
AU - Zhang, Zhuoli
AU - Almaraz, Esther Rodriguez
AU - Artim-Esen, Bahar
AU - Pardos-Gea, Jose
AU - Pons-Estel, Guillermo
AU - Pazzola, Giulia
AU - Shi, Hui
AU - Duarte-Garcia, Ali
AU - Barbhaiya, Medha
AU - Yelnik, Cecile
AU - Meroni, Pierluigi
AU - Roubey, Robert
AU - Bertolaccini, Maria Laura
AU - Cohen, Hannah
AU - Rand, Jacob H.
AU - Erkan, Doruk
N1 - Publisher Copyright:
© 2025 European Alliance of Associations for Rheumatology (EULAR). Published by Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
PY - 2026/3
Y1 - 2026/3
N2 - Objectives: There is a lack of high-quality data to inform risk-stratified long-term thrombosis prevention strategies in patients with persistently positive antiphospholipid antibodies (aPL). We aimed to determine independent clinical and biologic predictors of thrombosis among persistently aPL-positive patients. Methods: Patients positive for aPL according to the Revised Sapporo Classification Criteria are eligible for inclusion in the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Registry. Registrants with at least 1 year of follow-up were included in this study. We fit Cox proportional hazards models to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) for independent predictors of thrombosis. Results: In unadjusted analyses, based on 1067 patients with a mean follow-up of 4.43 years (4,727 person-years), history of thrombosis, hematologic disease (autoimmune haemolytic anaemia and/or thrombocytopenia), microvascular disease, obesity, renal disease, sedentary lifestyle, baseline anticoagulant use, and family history of early cardiovascular disease occurred more frequently (P < .05) among patients with new thrombosis (n = 93) than among those without new thrombosis (n = 974). After adjustment, independent predictors of new thrombosis were history of thrombosis (HR 2.34, 95% CI 1.14 to 4.81, P = .02) and hematologic disease (HR 1.95, 95% CI 1.19 to 3.18, P = .01); there was a trend for history of microvascular disease (P = .06) and obesity (P = .08). Conclusions: In this prospective analysis, history of thrombosis and hematologic disease each conferred an approximately twofold increased risk of new thrombosis in persistently aPL-positive patients. These findings can guide future clinical trial designs and inform patient management decisions.
AB - Objectives: There is a lack of high-quality data to inform risk-stratified long-term thrombosis prevention strategies in patients with persistently positive antiphospholipid antibodies (aPL). We aimed to determine independent clinical and biologic predictors of thrombosis among persistently aPL-positive patients. Methods: Patients positive for aPL according to the Revised Sapporo Classification Criteria are eligible for inclusion in the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) Registry. Registrants with at least 1 year of follow-up were included in this study. We fit Cox proportional hazards models to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) for independent predictors of thrombosis. Results: In unadjusted analyses, based on 1067 patients with a mean follow-up of 4.43 years (4,727 person-years), history of thrombosis, hematologic disease (autoimmune haemolytic anaemia and/or thrombocytopenia), microvascular disease, obesity, renal disease, sedentary lifestyle, baseline anticoagulant use, and family history of early cardiovascular disease occurred more frequently (P < .05) among patients with new thrombosis (n = 93) than among those without new thrombosis (n = 974). After adjustment, independent predictors of new thrombosis were history of thrombosis (HR 2.34, 95% CI 1.14 to 4.81, P = .02) and hematologic disease (HR 1.95, 95% CI 1.19 to 3.18, P = .01); there was a trend for history of microvascular disease (P = .06) and obesity (P = .08). Conclusions: In this prospective analysis, history of thrombosis and hematologic disease each conferred an approximately twofold increased risk of new thrombosis in persistently aPL-positive patients. These findings can guide future clinical trial designs and inform patient management decisions.
UR - https://www.scopus.com/pages/publications/105023842027
UR - https://www.scopus.com/pages/publications/105023842027#tab=citedBy
U2 - 10.1016/j.ard.2025.10.019
DO - 10.1016/j.ard.2025.10.019
M3 - Article
C2 - 41266210
AN - SCOPUS:105023842027
SN - 0003-4967
VL - 85
SP - 497
EP - 506
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 3
ER -